Negative pressure suction biopsy device

Abstract

The utility model discloses a kind of negative pressure suction type puncture biopsy apparatus, it is related to medical instrument field.The biopsy apparatus includes needle tube, needle core and pressure device, pressure device is detachably connected with needle tube, is fixed by clamping limiting portion.It has beneficial effect including improving sample quality, convenient operation and improving diagnostic efficiency.Needle tube has scale outside, bottom and needle core cooperate closely.Handle has antiskid line, connecting port and pressure device connecting pipe are closely adhered through conical structure.Needle core surface is smooth, and needle tube is closely adhered.Pressure device can be balloon expansion pressure pump etc., clamping limiting portion improves the stability of connecting portion.Under image guidance, puncture is operated as needed, and sample is obtained by adjusting negative pressure.The biopsy apparatus overcomes the problem that existing puncture biopsy mode is difficult to balance sample efficiency and tissue protection, and the problem of inconvenient operation, can adapt to different texture tissue, improve sample quality and representativeness, reduce operation difficulty and risk.

Description

Technical Field

[0001] This utility model relates to medical devices, specifically to a negative pressure aspiration biopsy device. Background Technology

[0002] In early medical diagnosis, obtaining tissue samples from lesions often relied on open surgery. This method is highly invasive, carries significant surgical risks, and results in slow recovery. Furthermore, given the complexity and risks of the procedure, it is unsuitable for preliminary diagnosis or sampling small lesions deep within the body. Early biopsy needles also had limitations in obtaining tissue samples. For example, some simple needles only penetrated the tissue through a core, resulting in low efficiency in obtaining sufficient and representative tissue samples. The needles were also prone to causing tissue compression and breakage during the puncture process, thus affecting the accuracy of pathological diagnosis. Some grooved biopsy needles required repeated punctures in the lesion area to obtain samples, which not only easily caused tissue damage but also consumed considerable physical energy.

[0003] For example, the ejector biopsy gun is a widely used medical device in clinical practice for obtaining tissue samples for pathological examination. Its biopsy needle has a carefully designed sampling groove whose length, width, and depth are optimized to accommodate a certain amount of tissue during ejection. Its key feature is the use of a built-in spring or other ejection mechanism to quickly trigger the puncture needle and obtain tissue, thereby improving the efficiency and accuracy of the biopsy procedure. Although designed to ensure sample integrity, the force during ejection is uncontrollable. Due to the high-speed puncture and the instantaneous shearing force, the tissue sample may still be squeezed or broken. For example, some softer lesions may suffer significant mechanical damage during puncture, affecting the accuracy of pathological diagnosis. Furthermore, for some harder tissues, it is not guaranteed that sufficient sample can be obtained even with high-speed puncture. Utility Model Content

[0004] The purpose of this invention is to overcome the existing problem of balancing the efficiency of sample acquisition with the protection of tissues.

[0005] To achieve the above objectives, the technical approach adopted by this utility model to solve its technical problem is as follows:

[0006] The needle structure combines a hollow needle tube with a detachable stylet. During puncture, the stylet assists in insertion; once in place, it is withdrawn, leaving the needle tube as a sample extraction channel. The detachable stylet enhances operational flexibility. The negative pressure device features an adjustable design, allowing for pressure adjustment via a lever. Increased negative pressure is used for hard, viscous, or clotted tissue, while decreased pressure is used for soft, sparse tissue. The procedure involves precise puncture under image guidance, followed by sequential removal of the stylet, adjustment of the negative pressure, connection of the device, and activation of the toggle switch for tissue aspiration. This streamlined and efficient process allows the operator to adjust flexibly according to the specific situation.

[0007] To achieve the above objectives, the technical solution adopted by this utility model to solve its technical problem is as follows:

[0008] The design of a negative pressure aspiration biopsy device is as follows:

[0009] A negative pressure aspiration biopsy device includes a needle tube, a needle core, and a pressure device. The needle core is movably disposed inside the needle tube. The device is characterized by a detachable connection between the pressure device and the needle tube, used to generate negative pressure inside the needle tube to extract tissue samples. A locking and limiting part is disposed at the connection between the pressure device and the needle tube.

[0010] Furthermore, the needle tube has a handle at the top, a locking groove at the top of the handle for limiting the needle core, and a connection port on one side.

[0011] Furthermore, a conical groove is provided inside the connection port.

[0012] Furthermore, the pressure device includes: a pressure section for generating negative pressure; a pressure gauge disposed on the pressure section; and a connecting pipe, one end of which is fixedly connected to the pressure section.

[0013] Furthermore, the other end of the connecting pipe is provided with a conical protrusion that matches the groove.

[0014] Furthermore, the snap-fit ​​limiting part includes a first annular protrusion disposed on the outside of the connection port, a second annular protrusion disposed on the thicker end of the conical protrusion, and a "C"-shaped limiting ring that cooperates with the two.

[0015] Furthermore, axial through holes are provided on the grooves and conical protrusions to ensure airflow.

[0016] The beneficial effects of this utility model are:

[0017] 1. Improved sample quality: The negative pressure aspiration biopsy needle can adjust the negative pressure according to tissue characteristics. For soft tissue, the negative pressure can be reduced to minimize damage, and samples of different textures can be extracted, increasing sample representativeness and making the sample more accurately reflect the lesion state.

[0018] 2. Convenient operation and adjustable negative pressure function allow the biopsy needle to adapt to various clinical scenarios. Regardless of different lesion tissues or complex anatomical sites, the operator can adjust the negative pressure as needed, reducing the difficulty and risk of operation and enhancing versatility and convenience.

[0019] 3. Improved diagnostic efficiency: This biopsy needle can quickly adjust the negative pressure according to the tissue condition, avoiding repeated attempts to extract samples. When encountering difficult-to-extract tissue, the negative pressure can be increased promptly to obtain the sample, reducing operation time, accelerating the pathological diagnosis process, and buying time for subsequent treatment. Attached Figure Description

[0020] Figure 1 This is a front view structural diagram of the present invention;

[0021] Figure 2 This is a cross-sectional structural diagram of the present invention;

[0022] Figure 3 for Figure 2 Enlarged view of section A;

[0023] Figure 4 This is an exploded structural diagram of the present invention;

[0024] Figure 5 for Figure 4 Enlarged view of section B;

[0025] Figure 6 for Figure 4 Enlarged view of section C;

[0026] Figure 7 This is a frontal fluoroscopic view of the biopsy needle of this utility model;

[0027] Figure 8 This is an exploded structural diagram of the pressure device of this utility model;

[0028] The above figures include the following reference numerals:

[0029] 10. Needle tube; 11. Handle; 111. Snap-fit ​​groove; 112. Connecting port; 1121. Groove; 12. Sealing cap; 20. Needle core; 21. Pressing element; 30. Pressure device; 31. Pressure section; 311. Injection tube; 312. Push rod; 313. Adjusting switch; 32. Pressure gauge; 33. Connecting tube; 331. Valve; 332. Conical protrusion; 40. Snap-fit ​​limiting part; 41. First annular protrusion; 42. Second annular protrusion; 43. Limiting ring. Detailed Implementation

[0030] The technical solutions in the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments, not all embodiments.

[0031] In the description of this utility model, it should be understood that the terms "front", "rear", "left", "right", "upper", "lower", "top", "bottom", "inner", "outer", etc., 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 utility model 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 limitations on this utility model.

[0032] Different biopsy needle sizes are typically used for different biopsy sites. For example, outer diameter specifications: thinner needles, such as around 0.7mm, are suitable for delicate procedures requiring minimal trauma or biopsies of children or special sites; while thicker needles, such as 2mm or even larger, are used when large amounts of tissue samples are needed. Length specifications: short needles may be between 3-5cm, used for biopsies of superficial lesions close to the body surface; longer needles can reach 15-20cm or longer, meeting the puncture needs of deep tissue lesions such as those in the abdominal cavity and pelvis. This device only exemplifies one type and does not mean that it is only suitable for this one size of biopsy needle, but rather that it is applicable to biopsy needles of various sizes.

[0033] refer to Figure 1-8 The needle 10 is made of medical-grade stainless steel, with a cylindrical, hollow, and smooth interior. This shape avoids additional damage to the wound, and the needle 10 allows for stable control by applying even force during puncture. Its outer surface is graduated in millimeters to accurately reflect the puncture depth, meeting clinical precision requirements. The bottom of the needle 10 is angled to match the tip of the needle core 20, resulting in a gradually narrowing shape. This ensures a tight fit between the needle 10 and needle core 20 during puncture, with a smooth transition at the interface, resulting in more even force transmission, reduced puncture resistance, and less tissue damage. Furthermore, the thin and sharp bottom of the needle 10 allows for rapid tissue cutting and sample aspiration when negative pressure is applied. The narrowing of the bottom also allows for more accurate tissue adsorption.

[0034] In practice, the handle 11 has a through channel in the middle, which is fitted with a sealing cap 12. This channel communicates with the needle tube 10, and the handle 11 is threadedly connected to the needle tube 10, ensuring that it will not loosen or detach during puncture or other operations. The handle 11 is elliptical cylindrical in shape and has anti-slip textured surfaces. This shape provides better directionality and force application while maintaining a certain level of grip comfort. The top of the handle 11 has a locking groove 111, which communicates with the aforementioned channel and cooperates with the pressing member 21 at the top of the needle core 20 to lock the needle core 20 in place, preventing it from falling into the needle tube 10 due to operational errors. The pressing member 21 is slightly shorter than the handle and has a smooth outer surface, which can distribute the upward force during needle core 20 puncture. This allows for more flexible and convenient handling.

[0035] A connection port 112 is provided on one side of the handle 11, and a first annular protrusion 41 is provided on the outside of the connection port 112.

[0036] Its interior features a regular groove 1121. This cone can be either a cone or a frustum. For example, if it is a cone, its apex angle can be designed between 30 and 60 degrees according to actual needs, ensuring sufficient depth variation to adjust the clamping force during the insertion of the connecting tube 33. The front end of the connecting tube 33 is set as a conical protrusion 332 that matches the cone shape inside the connecting port 112. These two cones have a high degree of geometric similarity in design to ensure a tight fit during insertion. The material of the conical part of the connecting tube 33 can be a material with a certain degree of elasticity. When inserted into the connecting port 112, it can undergo a slight elastic deformation to better adapt to the conical structure of the connecting port 112, enhancing the sealing and clamping effect. This tight fit makes it difficult for gas to leak at the connection. Under negative pressure, the internal pressure makes the connection between the connecting pipe 33 and the connecting port 112 tighter; under positive pressure, the external pressure presses the connecting pipe 33 tightly against the connecting port 112, thus ensuring a good seal under both pressure conditions. Axial through holes are provided on both the special connecting port 112 and the connecting pipe 33 to ensure airflow.

[0037] In practice, the needle core 20 is made of medical-grade stainless steel, with a smooth surface that allows it to slide and fit snugly inside the needle tube 10. When the needle core 20 is inserted into the needle tube 10, the needle tip just protrudes. The top of the needle core 20 is provided with a pressing element 21 that mates with the locking groove 111.

[0038] In specific implementation, the pressure device 30 is a balloon expansion pressure pump with prior art disclosure number CN110251811A (wherein the pressure gauge in the prior art is a positive pressure gauge, which can be replaced with a negative pressure gauge to meet the negative pressure requirements of this device). The pressure part 31 includes an injection tube 311 for containing gas; a push rod 312 is disposed in the injection tube 311 for pushing the gas in the injection tube 311 to enter the connecting tube 33; an adjustment switch 313 is disposed at the front end of the injection tube 311 for locking the push rod 312; a pressure gauge 32 is disposed at the lower end of the injection tube 311 for measuring the pressure in the injection tube 311; one end of the connecting tube 33 is fixedly connected to the air outlet of the injection tube 311, and the other end is provided with a valve 331 to control the flow direction of the gas. The other end port is a conical protrusion 332, and the thicker side of the conical protrusion 332 is provided with a first annular protrusion 41.

[0039] In specific implementation, the snap-fit ​​limiting part 40 includes a first annular protrusion 41, a second annular protrusion 42, and a "C"-shaped limiting ring 43. The limiting ring 43 has a groove inside. When the connecting tube 33 and the connecting port 112 are engaged, the distance between the first annular protrusion 41 and the second annular protrusion 42 is exactly equal to the width of the groove inside the limiting ring 43. At this time, the opening of the limiting ring 43 is aligned with the connection point and pressed down, so that the limiting ring 43 is fitted on the outside of the first annular protrusion 41 and the second annular protrusion 42, further improving the stability of the connection point.

[0040] In particular, the pressure device 30 of this device is not limited to balloon inflation pressure pumps; it is compatible with any device that can generate positive or negative pressure.

[0041] In practice, such as during a liver biopsy, the doctor first selects a biopsy needle of appropriate size based on the patient's condition. Guided by ultrasound or other imaging equipment, the doctor inserts the needle core into the needle tube, holds the handle, and inserts the biopsy needle into the liver tissue.

[0042] After the puncture reaches the target location, the doctor removes the needle core, creating a sample extraction channel in the needle tube 10. The pressure device 30 is then placed stably in the appropriate position. Valve 331 is closed to seal the entire device. The push rod 312 is pulled back to generate negative pressure. The adjusting switch 313 locks the push rod 312. The push rod 312 is then rotated for fine-tuning until the pressure gauge 32 reaches the set value. The connecting tube 33 is then connected to the connecting port 112. The adjusting switch 313 unlocks the push rod 312, generating negative pressure within the needle tube 10 to draw the tissue sample from the bottom into the needle tube 10. When it is necessary to remove the sample from the needle tube 10, the doctor holds the puncture needle, moves the adjusting switch 313 to the unlocked position, and slowly pushes the push rod 312 to apply pressure, expelling the liver tissue sample from the needle tube 10. After use, valve 331 is closed, the adjusting switch 313 is moved to the unlocked position, the push rod 312 is returned to its starting position, and the pressure device 30 is cleaned and properly stored.

[0043] The above description is merely a preferred embodiment of this utility model and is not intended to limit the utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A negative pressure aspiration biopsy device, comprising a needle tube (10), a needle core (20), and a pressure device (30), wherein the needle core (20) is movably disposed within the needle tube (10), characterized in that, The pressure device (30) is detachably connected to the needle tube (10) to generate negative pressure in the needle tube (10) to extract tissue samples. The locking and limiting part (40) is provided at the needle tube connection between the pressure device (30) and the needle tube (10). The needle tube (10) is provided with a handle (11) at the top end, and the handle (11) is provided with a snap-fit ​​groove (111) at the top end for limiting the needle core (20), and a connection port (112) is provided on one side. A conical groove (1121) is provided inside the connection port (112). The pressure device (30) includes: Pressure section (31) is used to generate negative pressure; A pressure gauge (32) is provided on the pressure unit (31); A connecting pipe (33) is fixedly connected at one end to the pressure part (31); The other end of the connecting pipe (33) is provided with a conical protrusion (332) that cooperates with the groove (1121). The snap-fit ​​limiting part (40) includes a first annular protrusion (41) disposed on the outside of the connection port (112), a second annular protrusion (42) disposed on the thicker end of the conical protrusion (332), and a "C"-shaped limiting ring (43) that cooperates with the two. The groove (1121) and the conical protrusion (332) are provided with axial through holes to ensure airflow.

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