A liver, gallbladder, pancreas and spleen puncture sampling device

Abstract

The present application relates to the technical field of puncture sampling, in particular to a liver, gallbladder and pancreas and spleen puncture sampling device, which comprises a puncture sampling needle, a negative pressure sampling cylinder arranged at the tail of the puncture sampling needle, a negative pressure interface and a handle ring arranged respectively on the tail and the side wall of the negative pressure sampling cylinder, the puncture sampling needle is rotationally connected to the head of the negative pressure sampling cylinder through the connecting seat of the tail of the puncture sampling needle, and the device further comprises a control mechanism arranged in the negative pressure sampling cylinder and connected to the tail of the puncture sampling needle, and a pressure adjusting ring is arranged on the control mechanism, so that the problems that the existing device is easy to mix non-target tissues or tissue fluids into the sample during puncture, affects the accuracy of pathological diagnosis, the negative pressure suction is opened in a multiple sudden jump mode, the sample integrity is easy to be damaged, the linear impact or sudden cutting action of puncture produces tissue vibration and displacement, reduces the sampling success rate, the sample is easy to be polluted, dried or lost during the sample transfer process, and the sampling sequence of part of the device lacks a reasonable mechanical linkage mechanism, and it is difficult to avoid the problem of mixing of tissue fluids.

Description

Technical Field

[0001] This invention relates to the field of puncture sampling technology, specifically to a liver, gallbladder, pancreas, and spleen puncture sampling device. Background Technology

[0002] In the diagnosis of diseases of abdominal solid organs such as the liver, gallbladder, pancreas, and spleen, puncture biopsy is a commonly used and important minimally invasive diagnostic method. Obtaining tissue samples from lesions through a puncture needle allows for pathological, cytological, or molecular biological analysis, providing crucial information for early disease detection, qualitative diagnosis, and treatment planning. Currently, widely used puncture sampling devices in clinical practice mainly include negative pressure suction biopsy needles, cutting biopsy needles, and combinations thereof.

[0003] Chinese Patent Publication No. CN114587432A discloses a painless clinical puncture and sampling device for the liver, gallbladder, pancreas, and spleen. One end of the puncture needle is equipped with a suction tube, and the upper and lower ends of the suction tube have grooves. A slider adapted to the grooves is slidably connected within the grooves. One end of the slider is fixedly connected to the puncture needle. A spring is installed in the groove near the puncture needle, and both ends of the spring are fixedly connected to the slider and the inner wall of the groove, respectively. A limiting block is fitted onto the end of the puncture needle near the groove, and a sampling hole is opened on the outer wall of the end of the puncture needle near the limiting block. A piston is slidably connected to the inner wall of the puncture needle. This invention, by setting up a puncture needle, an arc-shaped soft rubber sleeve, a fixing seat, a slider, a connecting rod, a connecting ring, a limiting block, and a pressing plate, facilitates painless clinical puncture and sampling of the liver, gallbladder, pancreas, and spleen, avoiding slippage and patient injury, and achieving a stable puncture effect.

[0004] However, existing puncture sampling devices such as those described above still have the following technical shortcomings in clinical puncture sampling: 1. Negative pressure suction is often activated by a sudden burst, which increases the negative pressure instantaneously. This can easily cause mucosal tears, local bleeding, tissue fragmentation, and even severe pain for the patient. It can also damage the integrity of the sample and reduce its diagnostic value.

[0005] 2. Linear impact or sudden cutting motion during puncture will cause significant tissue vibration and displacement, which not only increases patient discomfort, but may also cause the needle tip to deviate from the target area, reducing the sampling success rate. 3. During the process of the puncture needle entering the lesion tissue, the sampling window is often exposed to normal tissue fluid in advance, resulting in non-target tissue or tissue fluid being mixed into the sample, which seriously affects the accuracy of pathological diagnosis.

[0006] 4. The lack of a reasonable mechanical linkage mechanism in the sampling sequence makes it impossible to ensure that the cutting and sampling are carried out only after the surrounding tissue has been pushed aside to form an operating cavity, thus making it difficult to fundamentally avoid the mixing of tissue fluid. Summary of the Invention

[0007] The purpose of this invention is to provide a liver, gallbladder, pancreas, and spleen biopsy sampling device that overcomes the shortcomings of existing devices. Existing devices often introduce non-target tissues or tissue fluid into the sample when the needle enters the lesion, affecting the accuracy of pathological diagnosis. Their multi-sudden, snap-action negative pressure suction can instantly increase negative pressure, easily damaging sample integrity. Furthermore, the linear impact or sudden cutting motion of the puncture can cause tissue vibration and displacement, increasing patient discomfort and causing the needle tip to deviate from the target area, reducing the sampling success rate. In addition, transferring the sample to a preservation bottle or fixative after acquisition can easily lead to sample contamination, drying, or loss, affecting the reliability of subsequent testing. Finally, some devices lack a reasonable mechanical linkage mechanism for the sampling sequence, making it difficult to avoid the problem of tissue fluid contamination.

[0008] To achieve the above objectives, the technical solution adopted by the present invention to solve its technical problem is as follows: A liver, gallbladder, pancreas, and spleen biopsy sampling device was designed. Through the coordination of the control mechanism, the air bladder, and the elastic air bladder, tissue damage and bleeding can be reduced, sample contamination can be avoided, and patient discomfort can be minimized. Simultaneously, the unique structural design of the sampling needle improves the sampling success rate and sample quality. All components are tightly assembled and work in concert. The specific scheme is as follows: A liver, gallbladder, pancreas, and spleen biopsy sampling device includes a biopsy needle and a negative pressure sampling cylinder disposed at the tail of the biopsy needle. The negative pressure sampling cylinder has a negative pressure interface and a handle ring respectively disposed at its tail and side wall. The biopsy needle is rotatably connected to the head of the negative pressure sampling cylinder via a connecting seat at its tail. The device also includes: The control mechanism is located inside the negative pressure sampling cylinder and connected to the tail of the puncture sampling needle, and a pressure regulating ring is provided on the control mechanism.

[0009] Preferably, the control mechanism includes: The movable connecting seat has a frustum-shaped structure with a small head and a large tail, and is slidably connected inside the negative pressure sampling cylinder. Several insert rods for cooperating with the connecting seat are provided on the outer side of the head of the movable connecting seat, and the pressure regulating ring is provided at the tail of the movable connecting seat. The push rod is fixedly connected to the tail of the movable connecting seat, and the tail of the push rod is connected to the push handle after penetrating the tail wall of the negative pressure sampling cylinder. The first spring is sleeved on the push rod, with one end connected to the end face of the tail of the movable connecting seat and the other end connected to the inner wall of the tail of the negative pressure sampling cylinder.

[0010] Preferably, the tail of the puncture sampling needle is provided with a connecting seat, the connecting seat is provided with a rotating ring, and the rotating ring is rotatably connected in the rotating groove of the head of the negative pressure sampling cylinder.

[0011] Preferably, a plurality of the insertion rods are arranged in a circular array on the head end face of the movable connector, and each of them is provided with a guide protrusion on the outer side of its head; The tail of the connecting seat is provided with an annular drive groove along its axial direction, and the inner wall of the outer side of the annular drive groove is provided with a number of spiral guide grooves arranged in an annular array. Each of the aforementioned insert rods corresponds to one of the aforementioned guide grooves, allowing the guide protrusions to slide forward within the guide grooves and thus rotate the connecting seat.

[0012] Preferably, the rear end face of the movable connector is provided with four pressure regulating holes, the four pressure regulating holes are tapered holes with small heads and large tails, and are arranged symmetrically in pairs, and a breathable membrane is provided on the head end face of the movable connector. The pressure regulating ring is sleeved on the outside of the four pressure regulating holes. The inner side of the pressure regulating ring has four connecting plates arranged in a ring. The front sides of the four connecting plates are respectively connected to pressure regulating plugs by a second spring. The four pressure regulating plugs are conical cylindrical structures with small heads and large tails, and are respectively placed in the four pressure regulating holes.

[0013] Preferably, a sleeve is fitted around the outside of the puncture sampling needle, the tail of the sleeve is connected to the connecting seat at the tail of the puncture sampling needle, and an elastic airbag is provided at the head, the elastic airbag wrapping around the sampling window at the head of the puncture sampling needle. A ventilation gap is provided between the puncture sampling needle and the sleeve. A ventilation tube is connected to the head of the ventilation gap and is connected to the elastic air bladder. An air bladder is connected to the tail of the ventilation gap.

[0014] Preferably, the airbag is disposed inside the negative pressure sampling cylinder and located between several rods of the control mechanism, and the tail of the airbag is connected to the head of the movable connecting seat of the control mechanism through a corrugated telescopic tube. The airbag head is provided with two docking grooves, which are connected to the ventilation grooves on the connecting seat, and the ventilation grooves are connected to the ventilation gap.

[0015] Preferably, the sampling window is provided with two symmetrically arranged left and right sides, and a scraper is provided in the sampling window along its length direction, the width of the scraper being smaller than the width of the sampling window; One side of the scraper is fixedly connected to the inner wall of the left side of the sampling window, and the other side extends to the right and maintains the same curvature as the outer surface of the puncture sampling needle.

[0016] Preferably, the tail of the elastic airbag is fixedly connected to the sleeve, and the head is fitted to and slidably connected to the outside of the puncture sampling needle; The inner side of the head of the elastic airbag is also provided with a locking component, which includes: A telescopic ring is fixedly connected to the inner wall of the elastic airbag, and a plurality of elastic rods in a ring array are hinged to its front end face. The plurality of elastic rods are distributed axially along the inner wall of the elastic airbag. An arc-shaped retaining strip is connected to the front end of the elastic rod and is engaged in the annular groove provided at the head of the puncture sampling needle.

[0017] Preferably, a rinsing bottle is detachably connected to the upper side of the negative pressure sampling cylinder, and a sealing plate is inserted into the mouth of the rinsing bottle and connected to the corrugated telescopic tube through a first flexible tube; A collection bottle is detachably connected to the lower side of the negative pressure sampling cylinder. An opening and closing valve is provided at the mouth of the collection bottle, and it is connected to the corrugated telescopic tube through a second flexible hose. An elastic funnel is provided at the connection between the second flexible hose and the corrugated telescopic tube.

[0018] The beneficial effects of this invention are: 1. This invention features an automatically inflatable and deflated elastic airbag on the outer side of the puncture sampling needle tip, which, together with a locking assembly, forms a positioning and anti-slip structure. During needle insertion, the elastic airbag, under the limiting action of the arc-shaped locking strip and annular groove of the locking assembly, stably encloses the sampling window, completely isolating it from skin impurities, subcutaneous tissue, ascites, and surrounding normal mucosal tissue, thus preventing impurities from contaminating the sample at the source. During sampling, the airbag inflates and precisely exposes the sampling window through a mechanism-linked inflating mechanism. After sampling, the window automatically resets and closes, achieving a "closed needle insertion, open sampling, and closed needle withdrawal" operating mode throughout the process. This greatly improves the purity of the sample and avoids the problems of invalid sampling and repeated punctures.

[0019] 2. This invention utilizes a spiral transmission mechanism formed by the insert rod and guide protrusion at the head of the movable connecting seat, and the spiral guide groove and annular drive groove of the connecting seat. This mechanism converts the axial thrust of the push rod into the circumferential rotational force of the puncture sampling needle, achieving uniform and stable rotational cutting and sampling. Simultaneously, the puncture sampling needle is symmetrically equipped with two sets of elongated sampling windows, and each sampling window is equipped with a scraper conforming to the curvature of the needle body. This allows for the uniform peeling, scraping, and collection of lesion tissue, ensuring that a sufficient quantity, completeness, and uniformity of lesion tissue sample are obtained in a single sampling, adapting to various liver, gallbladder, pancreas, and spleen pathological testing needs.

[0020] 3. This invention features an adaptive negative pressure adjustment mechanism consisting of a pressure regulating ring, a second spring, a conical pressure regulating plug, and a conical pressure regulating orifice. Through the interaction of negative pressure suction and the elasticity of the second spring, the pressure regulating plug gradually retracts, and the ventilation gap of the pressure regulating orifice gradually widens, achieving a smooth gradient increase in negative pressure suction from weak to strong. This allows for flexible adsorption sampling throughout the entire process, effectively protecting the original tissue structure of the diseased tissue, eliminating sample damage and tissue tearing caused by instantaneous strong negative pressure, significantly improving the accuracy of pathological sections and detection analysis, and reducing the risk of intraoperative complications.

[0021] 4. This invention features a closed sample rinsing and collection system consisting of an independent rinsing bottle, a collection bottle, a first flexible tube, a second flexible tube, and an elastic funnel. Utilizing the gas-solid separation properties of the breathable membrane, the sample is stably contained within the corrugated telescopic tube, preventing it from being drawn away by negative pressure equipment. After sampling, the entire process is completed using sterile rinsing solution in a sealed environment, with precise flow guided by the elastic funnel, ensuring all residual and attached lesion tissue samples are completely flushed into the sterile collection bottle for sealing and preservation. The entire process is free of sample residue, loss, and external contamination, guaranteeing the integrity and standardization of sample collection. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall structure of a liver, gallbladder, pancreas and spleen puncture and sampling device according to the present invention; Figure 2 This is a schematic diagram of the internal structure of a liver, gallbladder, pancreas, and spleen puncture and sampling device according to the present invention. Figure 3 for Figure 2 A magnified view of a portion of point A in the middle; Figure 4 This is a schematic diagram showing the installation of the puncture sampling needle and the negative pressure sampling cylinder in the liver, gallbladder, pancreas and spleen puncture sampling device of the present invention. Figure 5 This is a schematic diagram of the inflation state of the elastic air bladder in the liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention. Figure 6 This is a schematic diagram of the negative pressure sampling cylinder in a liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 7 This is a schematic diagram of the internal structure of the negative pressure sampling cylinder in the liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 8 This is a schematic diagram of the control mechanism in a liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 9 This is a schematic diagram of the installation of the movable connecting seat in the liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 10 This is a schematic diagram of the internal structure of the pressure regulating ring in a liver, gallbladder, pancreas, and spleen puncture and sampling device of the present invention. Figure 11This is a schematic diagram of the structure of the air bladder in the liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 12 This is a schematic diagram of the pressure regulating ring in a liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 13 This is a schematic diagram of the installation of the flushing bottle and the collection bottle in the liver, gallbladder, pancreas and spleen puncture sampling device of the present invention; Figure 14 This is a schematic diagram of the puncture and sampling needle in the liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 15 This is a schematic diagram of the connecting seat in a liver, gallbladder, pancreas and spleen puncture and sampling device of the present invention; Figure 16 This is a schematic diagram of the clamping component in a liver, gallbladder, pancreas, and spleen puncture and sampling device of the present invention.

[0023] In the diagram: 1-Negative pressure sampling cylinder; 11-Handle ring; 12-Negative pressure interface; 13-Rotating groove; 2-Puncture sampling needle; 21-Sampling window; 22-Scraper; 23-Connecting seat; 231-Rotating ring; 232-Annular drive groove; 233-Guide groove; 234-Ventilation groove; 24-Annular retaining groove; 3-Sleeve; 31-Elastic airbag; 32-Ventilation tube; 33-Ventilation gap; 4-Collection bottle; 41-Opening and closing valve; 5-Airbag; 51-Docking groove ; 6-Modible connecting seat; 61-Pressure regulating hole; 62-Push rod; 63-First spring; 64-Push handle; 65-Insertion rod; 66-Ventilating membrane; 7-Pressure regulating ring; 71-Connecting plate; 72-Second spring; 73-Adjusting plug; 8-Corrugated telescopic tube; 81-Elastic funnel; 82-First hose; 83-Second hose; 9-Clamping assembly; 91-Telescopic ring; 92-Elastic rod; 93-Arc-shaped locking strip; 10-Rinse bottle; 101-Sealing plate. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the embodiments and accompanying drawings. The illustrative embodiments and descriptions of the present invention are only used to explain the present invention and are not intended to limit the present invention.

[0025] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that these specific details are not necessary to practice the invention. In other embodiments, well-known structures, circuits, materials, or methods have not been specifically described in order to avoid obscuring the invention.

[0026] Throughout this specification, references to "an embodiment," "an example," or "an example" mean that a particular feature, structure, or characteristic described in connection with that embodiment or example is included in at least one embodiment of the invention. Therefore, the phrases "an embodiment," "an example," "an example," or "an example" appearing in various places throughout the specification do not necessarily refer to the same embodiment or example. Furthermore, specific features, structures, or characteristics can be combined in one or more embodiments or examples in any suitable combination and / or sub-combination. Moreover, those skilled in the art will understand that the illustrations provided herein are for illustrative purposes and are not necessarily drawn to scale. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0027] In the description of this invention, the terms "front", "rear", "left", "right", "up", "down", "vertical", "horizontal", "high", "low", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the scope of protection of this invention.

[0028] like Figure 1-16 As shown, this invention provides a liver, gallbladder, pancreas, and spleen puncture and sampling device, including a puncture and sampling needle 2 and a negative pressure sampling cylinder 1 disposed at the tail of the puncture and sampling needle 2. The negative pressure sampling cylinder 1 is integrally injection molded from medical-grade polypropylene material, fully complying with clinical medical device standards. It is compatible with various sterilization methods such as high-temperature and high-pressure sterilization and ethylene oxide sterilization, and can be repeatedly sterilized and reused, reducing the cost of clinical consumables. The negative pressure sampling cylinder 1 has an overall cylindrical hollow cylinder structure with a wall thickness of 2-3mm, balancing structural strength and lightweight requirements, avoiding fatigue for medical personnel during prolonged hand operation. Two symmetrical handle rings 11 are integrally formed on the outer wall of the negative pressure sampling cylinder 1, which can effectively prevent the device from slipping out of the medical personnel's hands during puncture, improving operational stability. A negative pressure interface 12 is provided at the tail of the negative pressure sampling cylinder 1. The negative pressure interface 12 adopts a Luer connector structure or a threaded structure, which can be quickly and detachably connected to external negative pressure equipment, making operation convenient. The puncture sampling needle 2 is rotatably connected to the head of the negative pressure sampling cylinder 1 via the connecting seat 23 at its tail, and is used to puncture and obtain sampled tissue.

[0029] It also includes a control mechanism, housed within the negative pressure sampling cylinder 1 and connected to the tail of the puncture sampling needle 2. This mechanism controls the rotation of the puncture sampling needle 2 to achieve rotary cutting sampling, ensuring needle stability and preventing deviation from the target. A pressure regulating ring 7 is also provided on the control mechanism to adjust the negative pressure, gradually increasing the suction force from weak to strong. This avoids mucosal tearing, bleeding, and tissue fragmentation caused by sudden negative pressure, thus protecting sample integrity.

[0030] In the above scheme, the control mechanism includes a movable connecting seat 6, which has a frustum-shaped structure with a small head and a large tail, and is slidably connected inside the negative pressure sampling cylinder 1. It is made of medical-grade engineering plastic, and the outer diameter of its tail end is adapted to the inner diameter of the negative pressure sampling cylinder 1, allowing it to move flexibly along the axial direction within the negative pressure sampling cylinder 1. Several insertion rods 65 are provided at its head to cooperate with the connecting seat 23, driving the puncture sampling needle 2 to rotate and collect samples. A pressure regulating ring 7 is located at the tail of the movable connecting seat 6, which allows the sampling negative pressure to gradually increase, avoiding sudden increases.

[0031] The push rod 62 has a cylindrical structure. Its head is fixedly connected to the tail of the movable connecting seat 6, and its tail passes through the through hole in the tail wall of the negative pressure sampling cylinder 1 and extends to the outside of the negative pressure sampling cylinder 1. A push handle 64 is fixedly connected to the tail of the push rod 62. The surface of the push handle 64 is provided with anti-slip texture to facilitate medical personnel to push or pull the push rod 62, thereby driving the movable connecting seat 6 to move. The first spring 63 is sleeved on the push rod 62 and is in a normal state under normal conditions. It provides a restoring elastic force in the tail direction for the movable connecting seat 6 after it moves. One end of the spring 63 is connected to the end face of the tail of the movable connecting seat 6, and the other end is connected to the inner wall of the tail of the negative pressure sampling cylinder 1.

[0032] In the above scheme, the tail of the puncture sampling needle 2 is provided with a connecting seat 23, and the connecting seat 23 is provided with a rotating ring 231. The rotating ring 231 is rotatably connected in the rotating groove 13 provided at the head of the negative pressure sampling cylinder 1, which not only ensures the installation of the puncture sampling needle 2, but also allows it to rotate at the head of the negative pressure sampling cylinder 1.

[0033] Specifically, a circular rotating groove 13 is provided at the center of the head of the negative pressure sampling cylinder 1. The inner diameter of the rotating groove 13 is fitted with the outer diameter of the rotating ring 231 of the connecting seat 23 at the tail of the puncture sampling needle 2, which ensures that the puncture sampling needle 2 can rotate flexibly in a circular manner, while avoiding radial shaking and offset, thus ensuring accurate positioning for puncture sampling. A through hole is provided at the center of the tail of the negative pressure sampling cylinder 1. The inner diameter of the through hole is fitted with the outer diameter of the push rod 62, which achieves axial sliding sealing of the push rod 62. A medical silicone sealing gasket is embedded inside the through hole to prevent negative pressure leakage and ensure the stability of the negative pressure in the cavity.

[0034] In the above scheme, several insertion rods 65 are arranged in a ring array on the outside of the movable connecting seat 6, and each of them is provided with a guide slide protrusion 651 on the outside of its head; the tail of the connecting seat 23 is provided with an annular drive groove 232 along its axial direction, and the inner wall of the outer side of the annular drive groove 232 is arranged with several spiral forward guide slide grooves 233 in a ring array; the several insertion rods 65 correspond one-to-one with the several guide slide grooves 233, so that the guide slide protrusion 651 can slide forward in the guide slide groove 233 and drive the connecting seat 23 to rotate. When the push rod 62 drives the movable connecting seat 6 to move towards the head along the axial direction, the insertion rod will be inserted into the annular drive groove 232 and the guide slide protrusion 651 will be aligned with the top opening of the guide slide groove 233 and slide in. Then, when the insertion rod 65 is pushed forward, the sliding connection between the guide slide protrusion 651 and the guide slide groove 233 will force the connecting seat 23 to rotate, and finally drive the puncture sampling needle 2 to rotate and take a sample.

[0035] In the above scheme, four pressure regulating holes 61 are provided through the tail end face of the movable connecting seat 6. The four pressure regulating holes 61 have a conical hole structure with a small head and a large tail, and are arranged symmetrically in pairs. A breathable membrane 66 is provided on the head end face of the movable connecting seat 6. The breathable membrane 66 is made of medical PTFE or polypropylene microporous filter membrane, which is resistant to alcohol, glutaraldehyde, high temperature and high pressure, and meets the requirements of conventional medical device disinfection materials. The material itself is non-toxic and does not adsorb to tissues. The pressure regulating ring 7 is sleeved on the outside of the four pressure regulating holes 61. There are four connecting plates 71 arranged in a ring on the inside of the pressure regulating ring 7. The connecting plates 71 are integrally formed with the pressure regulating ring 7. The front side of the four connecting plates 71 is connected to the pressure regulating plug 73 through the second spring 72. The second spring 72 is in a compressed state to ensure that the pressure regulating plug 73 always blocks the pressure regulating hole 61 when it is not affected by negative pressure. The four pressure regulating plugs 73 are conical cylindrical structures with small heads and large tails, and are respectively placed in the four pressure regulating holes 61. By using the position of the pressure regulating plugs 73 in the pressure regulating holes 61, the air flow rate in the pressure regulating holes 61 is controlled to achieve different degrees of sealing, thereby adjusting the negative pressure of the negative pressure sampling cylinder 1 on the puncture sampling needle 2.

[0036] Specifically, during clinical sampling, as the external negative pressure device is activated, negative pressure suction is generated inside the cavity. The integrated structure formed by the connecting plate 71 and the pressure regulating ring 7 is fixedly connected to the movable connecting seat 6 and will not shift. The negative pressure suction overcomes the elasticity of the second spring 72, pulling the pressure regulating plug 73 to shift slightly backward, and a ventilation gap gradually forms between the pressure regulating plug 73 and the pressure regulating hole 61. As the negative pressure continues to increase, the displacement of the pressure regulating plug 73 gradually increases, the ventilation gap gradually widens, and the negative pressure suction of the cavity increases steadily from weak to strong. This completely eliminates the instantaneous strong suction generated by the sudden negative pressure of traditional devices, effectively avoiding problems such as tearing of the delicate mucosa of the liver, gallbladder, pancreas, and spleen, intraoperative bleeding, fragmentation of diseased tissue, and sample delamination damage, maximizing the protection of sample integrity and improving the accuracy of pathological testing.

[0037] In the above scheme, a sleeve 3 is sleeved on the outside of the puncture sampling needle 2. The tail of the sleeve 3 is connected to the connecting seat 23 at the tail of the puncture sampling needle 2. An elastic airbag 31 is provided at the head. The elastic airbag 31 wraps around the outside of the sampling window 21 at the head of the puncture sampling needle 2. The elastic airbag 31 is made of medical-grade latex material and has a ring structure. It tightly wraps around the outside of the sampling window 21 at the head of the puncture sampling needle 2. The elastic airbag 31 has good elasticity and can adapt to the puncture action of the puncture sampling needle 2. That is, it follows the order of first pushing open the surrounding mucosa and then rotating to take samples, so as to avoid the mixing of tissue fluid during sampling. Before and after puncture, the elastic airbag 31 completely wraps around the sampling window 21 at the head of the puncture sampling needle 2, but the puncture sampling needle 2 can extend the inflated elastic airbag 31 to take samples. The elastic airbag 31 plays a role in sealing and supporting during the puncture process.

[0038] A ventilation gap 33 is provided between the puncture sampling needle 2 and the sleeve 3. The ventilation gap 33 is distributed in a ring shape. The head is connected to a ventilation tube 32, which is connected to an elastic airbag 31. The tail of the ventilation gap 33 is connected to an airbag 5 through a ventilation groove 234, which can deliver the gas in the airbag 5 to the elastic airbag 31 to realize the inflation of the elastic airbag 31.

[0039] In the above scheme, the airbag 5 is made of medical-grade elastic rubber material, has an elliptical hollow structure, is set inside the negative pressure sampling cylinder 1, and its head is connected to the tail of the puncture sampling needle 2, and is located between several insertion rods 65 of the control mechanism to avoid interference with the movement of the insertion rods 65. The tail of the airbag 5 is connected to the head of the movable connecting seat 6 of the control mechanism via a corrugated telescopic tube 8. The head of the airbag 5 is provided with two docking grooves 51, which are connected to the ventilation grooves 234 on the connecting seat 23. The ventilation grooves 234 are connected to the ventilation gaps 33. When the movable connecting seat 6 moves towards the head, it can compress the airbag 5, and the gas in the airbag 5 is transported to the elastic airbag 31 through the ventilation grooves 234, the ventilation gaps 33 and the ventilation tubes 32, thereby inflating the elastic airbag 31. When the movable connecting seat 6 moves towards the tail, the airbag 5 returns to its original position under its own elasticity, and the gas in the elastic airbag 31 is drawn into the airbag 5, thereby deflating the elastic airbag 31.

[0040] Specifically, medical staff push the push rod 62 to move the movable connecting seat 6 axially toward the needle head. During the forward movement of the movable connecting seat 6, it directly squeezes the elliptical airbag 5, reducing the internal volume of the airbag 5. The internal gas is then quickly transported to the elastic airbag 31 through the docking groove 51, the ventilation groove 234, the annular ventilation gap 33, and the ventilation tube 32, causing the elastic airbag 31 to inflate rapidly. After sampling, the push rod 62 is released, and the first spring 63 drives the movable connecting seat 6 to return to its original position. The airbag 5 is released from compression and returns to its original position by its own elastic rebound, creating a negative pressure inside. This quickly draws the gas out of the elastic airbag 31, achieving automatic deflation and reset of the elastic airbag 31. The entire process requires no additional manual inflation or deflation, resulting in a high degree of automation and convenient operation.

[0041] In the above scheme, the sampling window 21 is elongated and extends along the length of the needle body. There are two symmetrical sampling windows 21. The symmetrical arrangement of the two sampling windows 21 can realize bidirectional sampling, improve sampling efficiency, and avoid the problem of insufficient sample volume caused by a single sampling window.

[0042] Sampling window 21 is provided with scrapers 22 distributed along its length. The width of scraper 22 is smaller than the width of sampling window 21. One side of scraper 22 is fixedly connected to the inner wall of the left side of sampling window 21, and the other side extends to the right and is consistent with the curvature of the outer surface of puncture sampling needle 2. When puncture sampling needle 2 is inserted into organ tissue, puncture sampling needle 2 is rotated, and scraper 22 can scrape the diseased organ tissue into sampling window 21. At the same time, under negative pressure, the sample is sucked into negative pressure sampling cylinder 1 to avoid the sample adhering to the inner wall of sampling window 21 and improve sampling integrity.

[0043] In the above scheme, the head and tail of the elastic airbag 31 are fixedly connected to the sleeve 3. The head fits and slides against the outside of the puncture sampling needle 2. After the elastic airbag 31 is inflated, its middle part will bulge. During the bulging process, the head of the elastic airbag 31 is pulled backward to expose the sampling window 21, which facilitates subsequent sampling. A clamping component 9 is also provided on the inner side of the head of the elastic airbag 31. The clamping component 9 includes a telescopic ring 91, which is made of telescopic elastic arc-shaped tubes of different diameters that are nested together. It can realize the expansion and contraction of the overall inner diameter of the telescopic ring 91. It is fixedly connected to the inner wall of the elastic airbag 31 and can adapt to the expansion and contraction of the elastic airbag 31. Several elastic rods 92 in a ring array are hinged to its front end face.

[0044] Several elastic rods 92 are axially distributed along the inner wall of the elastic airbag 31 and are slidably connected to the inner wall of the elastic airbag 31, so that the elastic rods 92 can adapt to the changes during the inflation of the elastic airbag 31. An arc-shaped locking strip 93 is connected to the front end of the elastic rod 92 and is locked in the annular groove 24 provided at the head of the puncture sampling needle 2. The locking relationship between the arc-shaped locking strip 93 and the annular groove 24 is used to lock the elastic airbag 31, which will prevent the elastic airbag 31 from retracting due to resistance during the insertion of the puncture sampling needle 2, thus affecting the normal puncture sampling work. After the elastic airbag 31 inflates, it will drive the elastic rod 92 to pull out the arc-shaped locking strip 93, so that the locking effect of the locking component 9 on the elastic airbag 31 is invalidated.

[0045] In the above scheme, a rinsing bottle 10 is detachably connected to the upper side of the negative pressure sampling cylinder 1 by means of a threaded connection. A sealing plate 101 is inserted into the mouth of the rinsing bottle 10 and is connected to the corrugated telescopic tube 8 through a first flexible tube 82. A collection bottle 4 is detachably connected to the lower side of the negative pressure sampling cylinder 1 by means of a threaded connection. An opening and closing valve 41 is provided at the mouth of the collection bottle 4 and is connected to the corrugated telescopic tube 8 through a second flexible tube 83. An elastic funnel 81 is provided at the connection between the second flexible tube 83 and the corrugated telescopic tube 8 to facilitate the collection of samples by the elastic funnel 81.

[0046] Specifically, after successful sample collection, the stable negative pressure generated by the external negative pressure device of the negative pressure sampling cylinder 1 is used to draw the lesion tissue sample obtained at the sampling window 21 at the tip of the puncture sampling needle 2 into the negative pressure sampling cylinder 1 located at the tail of the puncture needle. Since the head of the movable connecting seat 6 is equipped with a breathable membrane 66, which allows gas to pass through but not tissue samples, the obtained sample can be stably blocked inside the corrugated telescopic tube 8, preventing the sample from being drawn away by the negative pressure and causing contamination or sample loss. After the sample is isolated and positioned, the operator can open the pre-set opening and closing valve 41 at the mouth of the collection bottle 4, and at the same time pull out the sealing plate 101 inserted at the mouth of the rinsing bottle 10, so that the sealing plate 101 opens the liquid outlet channel of the rinsing bottle 10, allowing the sterile rinsing solution stored inside the rinsing bottle 10 to flow smoothly into the corrugated telescopic tube 8 along the first hose 82. Under the flushing action of the rinsing solution, the sample collected in the corrugated telescopic tube 8 is flushed smoothly into the collection bottle 4 below through the elastic funnel 81 and the second hose 83. Finally, the obtained sample is properly sealed and preserved for subsequent testing operations.

[0047] Specific implementation examples: The specific operating procedure for using this liver, gallbladder, pancreas, and spleen biopsy device includes the following: 1) Preoperative preparation Quickly plug and fix the external negative pressure device to the negative pressure interface 12 at the tail of the negative pressure sampling cylinder 1 to complete the negative pressure power docking.

[0048] Fill the rinsing bottle 10 with a sufficient amount of sterile tissue rinsing solution. Thread the rinsing bottle 10 and the collection bottle 4 to the upper and lower sides of the negative pressure sampling cylinder 1, respectively. Close the opening and closing valve 41 at the opening of the collection bottle 4. At the same time, fully insert the sealing plate 101 into the opening of the rinsing bottle 10 to close the rinsing solution channel and complete the preoperative equipment assembly.

[0049] 2) Localized puncture Medical staff hold the handles 11 on both sides of the negative pressure sampling cylinder 1, and, in conjunction with imaging equipment, locate the sampling sites for lesions in the liver, gallbladder, pancreas, and spleen. Maintaining the puncture sampling needle 2 perpendicularly aligned with the puncture site, they slowly and evenly push the device to complete the deep tissue puncture. Throughout the insertion process, the elastic balloon 31 remains fixed and does not slip under the limiting effect of the locking component 9. The arc-shaped locking strip 93 engages inside the annular groove 24 at the head of the puncture sampling needle 2, effectively resisting the resistance of the organ tissue during puncture and preventing the elastic balloon 31 from retracting and the sampling window 21 from being prematurely exposed. At this time, the elastic balloon 31 completely seals and encloses both sets of sampling windows 21, completely isolating subcutaneous tissue, ascites, and mucosal impurities, preventing impurities from entering the windows and causing sample contamination, until the puncture sampling needle 2 accurately reaches the preset lesion sampling depth, at which point the insertion operation is stopped.

[0050] 3) Inflation of the airbag After the needle tip of the puncture sampling needle 2 is positioned, the medical staff presses the push handle 64 forward at a uniform speed, causing the push rod 62 to slide forward along the axis of the negative pressure sampling cylinder 1, and simultaneously pushing the movable connecting seat 6 to move towards the head of the puncture sampling needle 2. During the forward movement of the movable connecting seat 6, the air bladder 5 inside the negative pressure sampling cylinder 1 is directly squeezed. The air bladder 5 deforms under the pressure, and the internal gas is quickly squeezed out. The gas passes through the docking groove 51 at the head of the air bladder 5, the ventilation groove 234 of the connecting seat 23, the ventilation gap 33 between the sleeve 3 and the puncture sampling needle 2, and the ventilation tube 32 at the head of the sleeve 3, and is finally delivered to the interior of the elastic air bladder 31.

[0051] After the elastic airbag 31 is inflated, the middle part bulges and expands. At the same time, the head of the elastic airbag 31 is pulled and slid slightly backward along the needle body to accurately expose the long strip-shaped sampling window 21 inside, thus opening the sampling area. At this time, the outer side of the airbag 31 is still attached to the mucosal tissue around the lesion, forming a local closed sampling space, isolating the surrounding normal tissue, and providing a closed environment for subsequent accurate sampling.

[0052] 4) Rotational sampling As the movable connecting seat 6 moves forward continuously, the multiple sets of insert rods 65 in the annular array at its head move forward synchronously. The guide protrusions 651 at the front end of the insert rods 65 are precisely inserted into the annular drive groove 232 at the tail of the connecting seat 23 and locked into the spiral guide groove 233. As the insert rods 65 continue to move forward axially, the spiral guidance of the guide groove 233 forces the connecting seat 23 to rotate uniformly within the rotating groove 13 at the head of the negative pressure sampling cylinder 1 via the rotating ring 231, thereby driving the overall puncture sampling needle 2 to rotate stably in a circular motion.

[0053] During the rotation of the puncture sampling needle 2, the scraper 22 fixed inside the sampling window 21 rotates synchronously with the needle body, uniformly and steadily scraping and cutting the lesion soft tissue at the lesion site. The two sets of symmetrical sampling windows 21 operate synchronously, greatly improving the efficiency of lesion tissue scraping and ensuring sufficient and complete sampled tissue.

[0054] 5) Sample adsorption Simultaneously with the scraping operation, the external negative pressure device is activated, and negative pressure is introduced into the internal cavity of the negative pressure sampling cylinder 1 through the negative pressure interface 12. The negative pressure in the cavity generates an adsorption force, overcoming the pre-tightening force of the second spring 72 inside the pressure regulating ring 7, pulling the pressure regulating plug 73 to move slightly backward along the conical pressure regulating hole 61. The pressure regulating hole 61 gradually opens the ventilation gap, and as the negative pressure increases, the gap width continues to increase, achieving a gradual and stable increase in the suction force of the cavity from weak to strong, completely avoiding the sudden strong negative pressure impact of traditional devices. The gradient change of negative pressure can slowly and stably adsorb and extract the diseased tissue scraped by the scraper 22 from the sampling window 21, effectively preventing tissue breakage, mucosal tearing, and intraoperative bleeding caused by instantaneous negative pressure, and maximizing the protection of the integrity of the sample tissue structure.

[0055] 6) Blocking and interception During the negative pressure adsorption process, the breathable membrane 66 on the head end face of the movable connector 6 plays a gas-solid separation role. The breathable membrane 66 only allows air and airflow to pass through, which can completely block the disease tissue sample, so that the scraped tissue sample is stably intercepted and positioned in the internal area of ​​the corrugated telescopic tube 8. This effectively prevents the sample from being continuously drawn into the negative pressure equipment by the negative pressure airflow, completely solving the problems of sample loss, contamination and loss, and ensuring that all sampled samples are retained in the collection channel of the device.

[0056] 7) Sample collection Manually open the valve 41 at the opening of collection bottle 4 to release the closed state of the collection channel; then pull out the sealing plate 101 at the opening of rinse bottle 10 to open the rinse fluid delivery channel. Under the action of gravity and a slight negative pressure, the sterile rinse fluid inside rinse bottle 10 flows into the corrugated telescopic tube 8 through the first tubing 82, thoroughly flushing and cleaning the lesion tissue samples adhering to and remaining on the tube wall. The rinsed sample flows downward with the rinse fluid, and is precisely converged and guided by the elastic funnel 81 at the connection between the corrugated telescopic tube 8 and the second tubing 83, finally flowing entirely into the sterile collection bottle 4 below, completing the sample collection. After the sample collection is completed, reinsert the sealing plate 101 to close the rinse channel, close the valve 41, and seal the collection bottle 4 for preservation to prevent sample contamination and evaporation.

[0057] 8) Reset and remove After sample collection is completed, medical staff release the pressed push handle 64. The first spring 63, which was in a compressed state, releases its elasticity, pushing the movable connecting seat 6, push rod 62, and push handle 64 to reset as a whole, and the device's transmission structure returns to its initial position. After the movable connecting seat 6 resets, it releases the pressure on the airbag 5. The airbag 5 resets due to its own elasticity, creating a negative pressure inside, which quickly draws the gas out of the elastic airbag 31. The elastic airbag 31 deflates, contracts, and resets, completely covering the sampling window 21 of the puncture sampling needle 2 head, achieving airtight protection of the sampling window.

[0058] Simultaneously, the second spring 72 inside the pressure regulating ring 7 rebounds and pushes the pressure regulating plug 73, completely sealing the pressure regulating hole 61 again, and the negative pressure in the cavity gradually dissipates. Finally, the medical staff slowly and evenly withdraws the puncture sampling needle 2, completing a complete minimally invasive puncture sampling procedure for the liver, gallbladder, pancreas, and spleen.

[0059] The above specific embodiments further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above are merely specific embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A liver, gallbladder, pancreas, and spleen puncture and sampling device, comprising a puncture and sampling needle (2), and a negative pressure sampling cylinder (1) disposed at the tail of the puncture and sampling needle (2), wherein a negative pressure interface (12) and a handle ring (11) are respectively disposed at the tail and side wall of the negative pressure sampling cylinder (1), characterized in that, The puncture sampling needle (2) is rotatably connected to the head of the negative pressure sampling cylinder (1) via a connecting seat (23) at the tail end, and also includes: The control mechanism is located inside the negative pressure sampling cylinder (1) and connected to the tail of the puncture sampling needle (2), and a pressure regulating ring (7) is provided on the control mechanism.

2. The liver, gallbladder, pancreas, and spleen biopsy sampling device according to claim 1, characterized in that, The control mechanism includes: The movable connecting seat (6) has a frustum structure with a small head and a large tail, and is slidably connected inside the negative pressure sampling cylinder (1). The outer side of the head of the movable connecting seat (6) is provided with several insert rods (65) for cooperating with the connecting seat (23). The pressure regulating ring (7) is located at the tail of the movable connecting seat (6). The push rod (62) is fixedly connected to the tail of the movable connecting seat (6), and the tail passes through the negative pressure sampling cylinder (1) and is connected to the push handle (64). The first spring (63) is sleeved on the push rod (62), with one end connected to the tail end face of the movable connecting seat (6) and the other end connected to the inner wall of the tail of the negative pressure sampling cylinder (1).

3. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 2, characterized in that, The puncture sampling needle (2) is provided with a connecting seat (23) at its tail end. The connecting seat (23) is provided with a rotating ring (231). The rotating ring (231) is rotatably connected to the rotating groove (13) at the head of the negative pressure sampling cylinder (1).

4. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 2, characterized in that, Several of the aforementioned insert rods (65) are arranged in a ring on the head end face of the movable connecting seat (6), and guide slide protrusions (651) are respectively provided on the outer side of their heads. The connecting seat (23) has an annular drive groove (232) at its tail along its axial direction, and the annular drive groove (232) has a number of spiral guide grooves (233) arranged in annular array on the inner wall of its outer side. Several of the insert rods (65) correspond one-to-one with several of the guide grooves (233), so that the guide protrusion (651) can slide forward in the guide groove (233) and drive the connecting seat (23) to rotate.

5. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 2, characterized in that, The movable connecting seat (6) has four pressure regulating holes (61) through the tail end face. The four pressure regulating holes (61) are tapered holes with small heads and large tails, and are arranged symmetrically in pairs. A breathable membrane (66) is provided on the head end face of the movable connecting seat (6). The pressure regulating ring (7) is sleeved on the outside of the four pressure regulating holes (61). The inner side of the pressure regulating ring (7) has four connecting plates (71) arranged in a ring. The front sides of the four connecting plates (71) are respectively connected to pressure regulating plugs (73) by second springs (72). The four pressure regulating plugs (73) are conical cylindrical structures with small heads and large tails, and are respectively placed in the four pressure regulating holes (61).

6. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 1, characterized in that, The outer side of the puncture sampling needle (2) is fitted with a sleeve (3), the tail of the sleeve (3) is connected to the connecting seat (23) at the tail of the puncture sampling needle (2), and the head is provided with an elastic airbag (31), which wraps around the sampling window (21) at the head of the puncture sampling needle (2). A ventilation gap (33) is provided between the puncture sampling needle (2) and the sleeve (3). A ventilation tube (32) is connected to the head of the ventilation gap (33). The ventilation tube (32) is connected to the elastic airbag (31). An airbag (5) is connected to the tail of the ventilation gap (33).

7. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 6, characterized in that, The airbag (5) is placed inside the negative pressure sampling cylinder (1) and located between several rods (65) of the control mechanism. The tail of the airbag (5) is connected to the head of the movable connecting seat (6) of the control mechanism through a corrugated telescopic tube (8). The airbag (5) has two docking grooves (51) at its head. The two docking grooves (51) are connected to the ventilation groove (234) on the connecting seat (23). The ventilation groove (234) is connected to the ventilation gap (33).

8. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 6, characterized in that, The sampling window (21) is provided with two symmetrically arranged on the left and right sides. The sampling window (21) is provided with a scraper (22) distributed along the length direction. The width of the scraper (22) is smaller than the width of the sampling window (21). The scraper (22) is fixedly connected to the inner wall of the left side of the sampling window (21) on one side, and extends to the right on the other side, maintaining the same curvature as the outer surface of the puncture sampling needle (2).

9. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 6, characterized in that, The tail of the elastic airbag (31) is fixedly connected to the sleeve (3), and the head is fitted and slidably connected to the outside of the puncture sampling needle (2); The inner side of the head of the elastic airbag (31) is also provided with a locking component (9), the locking component (9) including: The telescopic ring (91) is fixedly connected to the inner wall of the elastic airbag (31), and a number of elastic rods (92) in a ring array are hinged to its front end face. The number of elastic rods (92) are distributed axially along the inner wall of the elastic airbag (31). An arc-shaped retaining strip (93) is connected to the front end of the elastic rod (92) and is locked in the annular retaining groove (24) provided at the head of the puncture sampling needle (2).

10. The liver, gallbladder, pancreas, and spleen puncture and sampling device according to claim 7, characterized in that, The upper side of the negative pressure sampling cylinder (1) is detachably connected to a rinsing bottle (10), and a sealing plate (101) is inserted into the mouth of the rinsing bottle (10), and is connected to the corrugated telescopic tube (8) through a first flexible tube (82); The negative pressure sampling cylinder (1) is detachably connected to a collection bottle (4). The collection bottle (4) is provided with an opening and closing valve (41) at its mouth and is connected to the corrugated telescopic tube (8) through a second flexible hose (83). An elastic funnel (81) is provided at the connection between the second flexible hose (83) and the corrugated telescopic tube (8).

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