A puncture needle device for nephrology

Abstract

The application discloses a puncture needle device for nephrology and a sampling method, and belongs to the technical field of medical devices. The device comprises an outer sleeve needle body, an inner core assembly, a driving control assembly and a sampling structure. The inner sleeve needle body is internally provided with a sampling cavity and a sampling cavity which are independent of each other, the inner core assembly is coaxially assembled in the sampling cavity in a detachable manner, and is used for carrying out the acquisition, cutting and containing of tissues. The driving control assembly is in transmission cooperation with the inner core assembly, and provides driving force for the inner core assembly to complete the sampling action. The sampling structure is movably arranged in the sampling cavity, and is used for receiving and taking out the inner core assembly after the sampling is completed. The application adopts a pure mechanical structure design, keeps the outer sleeve needle body fixed after single puncture is in place, and realizes multiple continuous sampling only by replacing the inner core assembly, so that the defects of low sampling efficiency, easy sample damage, high risk of patient injury and the like of the existing puncture needle are solved, and the application has the advantages of convenient operation, safety and reliability.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a puncture needle device for nephrology. Background Technology

[0002] Renal biopsy is a crucial diagnostic and therapeutic procedure in nephrology used to clarify the pathological type of kidney disease, assess the severity of the condition, and guide the selection of clinical treatment plans. The puncture needle device, as the core instrument of this procedure, directly determines sampling efficiency, sample integrity, and patient safety. Currently, all nephrology puncture needle devices used clinically are purely mechanical in structure, mainly divided into manual puncture needles and semi-automatic / automatic puncture needles according to their operation and structure. The core of each device consists of a needle body (outer cannula) and an inner core. Existing technology has significant shortcomings in clinical application, as detailed below: Traditional manual puncture needles typically employ an integrated structure where the needle body and inner core are fixed together, and the inner core and outer sheath are not detachable, allowing only single punctures and single sampling. Clinical pathology testing often requires multiple examinations, including light microscopy, immunofluorescence, and electron microscopy, usually requiring 2-3 qualified kidney tissue samples containing sufficient glomeruli. In such cases, medical staff must remove the entire puncture needle, reposition it, disinfect it, and puncture again. This process is not only cumbersome and time-consuming but also significantly increases patient discomfort and the risk of complications such as renal bleeding, damage to surrounding tissues, and infection. Furthermore, multiple punctures can lead to positioning errors, resulting in inaccurate sampling sites and reducing the objectivity and reliability of pathological diagnoses.

[0003] With technological advancements, some semi-automatic puncture needles employ a design where the needle body and inner core are separable, enabling "core replacement without needle body replacement." This allows for multiple samplings with a single puncture and core replacement, reducing the number of punctures and patient discomfort to some extent. However, the inner core structure of these needles is simple, often consisting of a solid needle or a simple hollow needle, lacking functional auxiliary modules. Firstly, there is no dedicated tissue manipulation and aspiration structure; sampling relies solely on the needle's advancement and withdrawal, making it difficult to accurately obtain kidney tissue from the target area. This can lead to insufficient sample volume, sample breakage, and sampling deviations. When dealing with fibrotic kidney tissue or hardened lesions, sampling becomes significantly more difficult. Secondly, there is no dedicated tissue cutting structure. During the puncture channel closure and core removal process, the obtained tissue cannot be effectively cut and separated, easily causing sample loss or damage, or secondary injury and bleeding risks due to tissue adhesion pulling on the kidney.

[0004] In addition, existing replaceable inner cores and needles are mostly connected by simple snap-fit ​​or plug-in connections, resulting in poor positioning accuracy when switching inner cores and easy coaxiality deviation, which affects the accuracy of subsequent sampling positioning. At the same time, the inner core sampling channel is poorly designed and lacks tissue retention structure, making it easy for samples to fall out and become contaminated during the removal of the inner core, damaging the integrity of the sample and interfering with the accuracy of pathological test results.

[0005] In summary, existing nephrology puncture needle devices, whether integrated fixed type or separable core type, generally suffer from low sampling efficiency, unstable sample quality, and high risk of patient injury. They are unable to meet the actual clinical needs of nephrology for accurate, efficient, and safe multiple sampling. There is an urgent need for a new puncture needle device with optimized structure to solve the above-mentioned technical defects. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a nephrology puncture needle device. This device solves the problems of low sampling efficiency, easy sample damage, high risk of patient injury, and inaccurate positioning of existing puncture needles by means of a replaceable inner core, a tissue aspiration structure, a tissue cutting structure, and a precise positioning connection structure.

[0007] To achieve the above objectives, the technical solution adopted by the present invention to solve its technical problem is as follows: A puncture needle device for nephrology is designed, and the specific scheme is as follows: A nephrology puncture needle device is characterized by comprising: The outer tube needle body is an integral hollow tubular structure, with independent sampling chambers and sampling cavities arranged along its length. The inner core assembly is detachably coaxially assembled inside the sampling chamber and is used to perform tissue acquisition, cutting, and containment. A drive control component, movably mounted on the outer cannula needle body and engaging with the inner core component, is used to provide driving force to the inner core component to complete the sampling action; and The sampling structure is movably set inside the sampling chamber and is used to receive and remove the inner core component after sampling.

[0008] Furthermore, the front end of the outer cannula needle body is provided with a puncture needle, the side wall of the puncture needle is provided with a side sampling port, and the inside of the puncture needle is provided with a sealing opening and closing structure that cooperates with the side sampling port. The sealing opening and closing structure includes a drive structure, a spiral track, a return spring, and a columnar movable plate. The spiral track is set on the inner wall of the puncture needle, and the drive structure slides in conjunction with the spiral track. When the drive structure is pressed down by the inner core assembly, the drive structure rotates while moving downward along the spiral track. The columnar movable plate is fixedly connected to the drive structure and is used to selectively open or block the side sampling port under the drive of the drive structure. The reset spring is used to drive the drive structure to reset.

[0009] Furthermore, the core components include: The shell is internally divided into a first chamber and a second chamber by a flexible rubber diaphragm. The first chamber is provided with a sampling opening for tissue entry. The driving component is elastically mounted on the upper end of the housing and can slide back and forth axially relative to the housing. The transmission rod has one end connected to the rubber diaphragm and the other end abutting against the driving component. When the driving component slides downward, the transmission rod is driven to move, causing the rubber diaphragm to deform, thereby expanding the volume of the first chamber to form a negative pressure. An arc-shaped door is movably mounted at the sampling opening and is connected to a drive component. When the drive component slides downward, the arc-shaped door is driven to rotate and open the sampling opening.

[0010] Furthermore, the inner core assembly also includes a cutting blade disposed at the edge of the sampling opening. When the arc-shaped door is closed, the edge of the arc-shaped door and the cutting blade form a shearing engagement to cut the tissue sucked into the first chamber.

[0011] Furthermore, the sampling chamber is equipped with a one-way valve and a lifting assembly; The one-way valve is a flexible flap structure, hinged to the upper inner wall of the sampling chamber, and can only be flipped downwards; The lifting assembly includes a lifting block and a lifting rope. The lifting block is axially slidably disposed in the lower part of the sampling chamber. One end of the lifting rope is connected to the lifting block, and the other end extends to the outside of the outer cannula needle body. The bottom of the inner core assembly and the lifting block are provided with mutually cooperating inclined surfaces, and the top of the inner core assembly and the one-way valve are provided with mutually cooperating inclined surfaces. When the lifting rope is pulled upward, the lifting block pushes the inner core assembly upward through the inclined surface, and the inclined surface at the top of the inner core assembly abuts against the inclined surface of the one-way valve, thereby driving the inner core assembly to move laterally from the sampling chamber to the sampling chamber.

[0012] Furthermore, the drive control assembly includes a spring rod, an abutment rod, and a compression spring; The elastic rod is axially slidably disposed in the operating cavity of the outer tube needle body, and the top pressure spring is used to drive the elastic rod to reset. The abutment rod is horizontally slidably mounted at the bottom of the elastic rod, and a return spring is provided between the abutment rod and the elastic rod; The horizontal section of the abutment rod and the bottom of the elastic rod are provided with mutually cooperating inclined surfaces. When the elastic rod is pressed down, the inclined surfaces drive the abutment rod to extend horizontally to abut against the inner core assembly.

[0013] Furthermore, the sampling structure is an L-shaped component, including a horizontal bearing section and a vertical lifting section. The horizontal bearing section slides against the bottom of the sampling chamber to support the inner core assembly, and the vertical lifting section extends upward to the outside of the outer cannula needle body.

[0014] A sampling method using a nephrology puncture needle device, characterized by comprising the following steps: Puncture positioning: Insert the outer cannula needle body to the target position and keep it fixed; Drive sampling: Operate the drive control component to actuate the pre-installed core assembly to open the side sampling port and draw tissue into the core assembly; Cutting and Resetting: Cancel the operation on the drive control component, reset the inner core component and cut the tissue, and close the side sampling port at the same time; Core displacement: Operate the lifting assembly to move the core assembly containing the tissue sample axially and laterally into the sampling chamber under the action of the guide structure; Core removal: The core assembly located in the sampling chamber is removed through the sampling structure.

[0015] Furthermore, it also includes a core replacement step: after removing the core assembly containing the tissue sample, a new core assembly is inserted into the sampling chamber, and the steps of driving sampling, cutting and resetting, core displacement and core removal are repeated without moving the outer cannula needle body, so as to achieve multiple continuous sampling.

[0016] The beneficial effects of this invention are: 1. This invention employs a purely mechanical structure with separate outer cannula needle body and inner core assembly. Once the needle body is in place after a single puncture, it remains fixed throughout the procedure. Multiple tissue samples can be obtained simply by replacing the inner core assembly. This design fundamentally avoids the drawbacks of traditional puncture needles that require repeated punctures and repositioning to obtain multiple samples. It significantly reduces the risk of kidney tissue damage, bleeding, and infection caused by multiple punctures, while also shortening the operation time and alleviating patient suffering.

[0017] 2. This device utilizes negative pressure suction within the inner core assembly, the smooth shearing action of the arc-shaped door and cutting blade, and the timing control of the sealing and opening / closing structure of the side sampling port to ensure a stable and controllable process for tissue acquisition, cutting, and sealing. The cut tissue sample remains intact within the first chamber, ensuring no contact, compression, or contamination during subsequent transfer and retrieval. This avoids the sample damage or deformation issues common in traditional sampling methods, guaranteeing sample quality and simultaneously meeting the high requirements for sample quantity and quality in multiple pathological examinations, including light microscopy, immunofluorescence, and electron microscopy.

[0018] 3. This invention employs a purely mechanical structure. The drive and control components, lifting components, and sampling structure achieve transmission and displacement through inclined plane cooperation and spiral track guidance, requiring no electrical components or complex control systems. It is intuitive to operate, has a low failure rate, and low manufacturing cost. Medical personnel only need to perform simple actions such as pressing and pulling to complete a series of operations including sampling, core displacement, and core removal. The process is simple and smooth. Furthermore, the core component is an independently sterile, disposable part, avoiding the risk of cross-infection, and possesses good clinical applicability and promotional value. Attached Figure Description

[0019] Figure 1This is a schematic diagram of the structure of the present invention; Figure 2 This is a schematic diagram of the cross-sectional structure of the present invention; Figure 3 for Figure 2 Schematic diagram of part A in the middle; Figure 4 for Figure 3 Enlarged view of section C; Figure 5 This is a top view of the structure of the present invention; Figure 6 for Figure 2 Schematic diagram of Part B in the middle section; Figure 7 This is a top view of the outer tube needle body; Figure 8 This is an exploded structural diagram of the inner core components; Figure 9 This is a schematic diagram of the core component structure; Figure 10 Top view of the inner core assembly; Figure 11 for Figure 10 Schematic diagram of cross section along the EE direction; Figure 12 This is a schematic diagram of the core component structure; Figure 13 This is a cross-sectional view of the inner core component; Figure 14 This is a schematic diagram of a partial structure of an arc-shaped door.

[0020] The above figures include the following reference numerals: 1. Outer cannula needle body; 10. Shell; 101. Operating chamber; 102. Sampling chamber; 103. Sampling cavity; 11. Rubber diaphragm; 12. First chamber; 13. Second chamber; 14. Transmission rod; 15. Inclined slide; 16. Arc-shaped door; 161. Guide rod; 17. Cutting blade; 18. Puncture needle; 2. Inner core assembly; 20. First inclined surface; 21. Lifting block; 22. Second inclined surface; 23. Lifting rope; 24. One-way valve; 25. Third inclined surface; 27. Elastic rod; 28. Top pressure spring; 29. ​​Abutment rod; 3. Sampling port; 31. Matching inclined surface; 32. Sampling structure; 4. Drive control assembly; 5. Drive structure; 6. Spiral track; 7. Reset spring; 9. Drive component; 91. Top spring. Detailed Implementation

[0021] The technical solutions in 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, and not all embodiments.

[0022] In the description of this invention, 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 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 limitations on this invention.

[0023] refer to Figure 1-14 This invention discloses a nephrology puncture needle 18 device, which adopts a purely mechanical structure design and is specifically designed for multiple, precise, and low-damage sampling of kidney tissue during renal biopsy. It can keep the outer cannula needle body 1 fixed throughout the entire process after the first puncture is completed, and achieve continuous multiple sampling only by inserting the inner core component 2, driving the sampling, lateral displacement, and removal and replacement. It fundamentally solves the technical defects of existing puncture needles 18, such as low sampling efficiency, easy sample damage, high risk of patient injury, poor coaxiality, and cumbersome operation.

[0024] In practice, the outer cannula needle body 1 is an integral hollow slender tubular structure. The inner cavity is divided by a longitudinal sealing partition to form an independent operating chamber 101, a sampling chamber 102, and a sampling chamber 103. The three chambers are arranged parallel to each other along the length of the outer cannula needle body 1. The front end of the outer cannula needle body 1 is a puncture needle 18, and a lateral sampling port 3 is opened on the side wall of the needle tip. The lateral sampling port 3 is a rectangular or arc-shaped through hole that penetrates the side wall of the needle tip, serving as a sampling channel for kidney tissue to enter the device. In the initial state, the lateral sampling port 3 is completely sealed to prevent tissue from accidentally entering or body fluid from leaking during puncture.

[0025] In practice, the inner core assembly 2 is fitted with a clearance fit inside the sampling cavity 103 of the outer cannula needle body 1. The inner core assembly 2 slides along the axis of the sampling cavity 103. The sampling cavity 103 provides circumferential positioning for replacing the inner core assembly 2 and restricts the radial movement and circumferential deflection of the inner core assembly 2. The bottom of the sampling cavity 103 is in communication with the puncture needle 18.

[0026] In practice, the inner core component 2 is made of medical-grade stainless steel and is a disposable sterile component, including a top drive component 9, a housing 10, a transmission actuation structure, a sealing and opening / closing structure, and a tissue cutting structure. The housing 10 is a cylindrical structure.

[0027] The drive component 9 is elastically mounted above the partition plate at the top of the first chamber 12 and the second chamber 13 via a top spring 91. The partition plate is provided with a rectangular guide post that cooperates with the bottom of the drive component 9. The drive component 9 can slide axially downward relative to the housing 10 under the action of external force. After the external force is removed, the drive component 9 automatically returns to its original position under the action of the top spring 91. A transition cavity is formed between the drive component 9 and the housing 10. The inner wall of the transition cavity is machined with a guide spiral track 6, which is used to cooperate in realizing the rotation opening and closing of the arc-shaped door 16.

[0028] The housing 10 is internally fitted with a flexible rubber diaphragm 11 that seals and divides it into a first chamber 12 and a second chamber 13. The tops of the first chamber 12 and the second chamber 13 are fitted with partitions, and the bottoms of the first chamber 12 and the second chamber 13 are fitted with inclined surfaces. The first chamber 12 is the sampling execution chamber, with a sampling opening on its side wall corresponding to the side sampling port 3, for receiving kidney tissue. The second chamber 13 is a sealed, variable-volume chamber. The two chambers are completely isolated and do not communicate with each other, ensuring stable air pressure transmission. An L-shaped transmission rod 14 is fixedly connected to the inner wall of the inner rubber diaphragm 11. The horizontal section of the L-shaped transmission rod 14 is vertically connected to the rubber diaphragm 11, and the vertical section extends upward and passes through the partition to abut against the bottom end face of the drive component 9. An inclined slide 15 is provided at the bottom of the drive component 9. The inclined slide 15 is a continuous slope, and the slope tends to be higher as it gets closer to the edge of the drive component 9. In the initial state, the top of the vertical section of the L-shaped transmission rod 14 abuts against the lower end of the inclined slide 15, and the two remain in contact. When the driving component 9 slides downward relative to the housing 10 under the action of external force, the distance between the driving component 9 and the housing 10 gradually decreases. The vertical section of the L-shaped transmission rod 14 slides along the inclined slide 15 and moves horizontally towards the edge of the driving component 9 under the guidance of the inclined surface. This causes the rubber diaphragm 11 to undergo elastic deformation, which passively reduces the internal volume of the second chamber 13. While the volume of the second chamber 13 decreases, the volume of the first chamber 12 expands synchronously under the pull of the rubber diaphragm 11. Since the first chamber 12 is a semi-closed structure, the expansion of the volume creates a relative negative pressure inside, providing power for tissue aspiration.

[0029] In specific implementation, an arc-shaped door 16 and a cutting blade 17 are assembled at the sampling opening of the first chamber 12. The arc-shaped door 16 matches the curvature of the outer wall of the first chamber 12. It can completely block the sampling opening when fitted onto the outer wall of the first chamber 12 and slide along the outer wall of the first chamber 12. A telescopic guide rod 161 is fixedly connected to the top of the arc-shaped door 16. A guide block is fixedly connected to the top of the guide rod 161. The guide rod 161 is set in the transition cavity between the driving component 9 and the housing 10. A protrusion is provided on the top of the guide rod 161 and abuts against the spiral track on the inner wall of the transition cavity. When the driving component 9 moves downwards towards the housing 10, the bottom of the driving component 9 abuts against the upper end of the guide rod 161, pushing the guide rod 161 to retract downwards and rotate circumferentially along a spiral track. The guide rod 161 simultaneously drives the telescopic guide rod 161 and the arc-shaped door 16 to rotate around the central axis of the housing 10, causing the arc-shaped door 16 to gradually open. The sampling opening of the first chamber 12 is aligned with the side sampling port 3 of the outer cannula needle body 1. Under the negative pressure inside the first chamber 12, the kidney tissue is stably drawn into the first chamber 12 through the side sampling port 3 and the sampling opening, completing the tissue acquisition. When the pressure on the drive member 9 is released, the drive member 9 is lifted and reset under the action of the top spring 91. The spring inside the guide rod 161 drives the guide rod 161 to extend and rotate in the opposite direction along the spiral track 6. The arc-shaped door 16 rotates in the opposite direction and closes synchronously. During the closing process, the edge of the arc-shaped door 16 forms a shearing engagement with the cutting blade 17 to make a flat cut on the kidney tissue that has entered the first chamber 12. The cut tissue sample is completely retained inside the first chamber 12.

[0030] In specific implementation, a first inclined surface 20 is provided at the bottom of the housing 10 of the inner core component 2. The first inclined surface 20 slopes upward from the front end of the housing 10 to the rear end of the housing 10, and the inclined surface has a smooth transition without sharp edges. Inside the sampling chamber 103, a lifting block 21 is provided at the bottom position of the housing 10. A second inclined surface 22 is machined on the upper end of the lifting block 21. The second inclined surface 22 has the same angle as the first inclined surface 20 at the bottom of the housing 10 and fits in close contact to form an inclined surface transmission pair. The lifting block 21 slides axially along the inner wall of the sampling chamber 103. A lifting rope 23 is fixedly connected to the top of the lifting block 21. The lifting rope 23 is a flexible non-elastic traction rope that extends through the tube wall of the outer tube needle body 1 to the outside. The exposed end is provided with a gripping end for the operator to pull manually. A one-way valve 24 is hinged to the upper inner wall of the sampling chamber 103. The one-way valve 24 is an elastic flap structure with a third inclined surface 25 machined on its bottom surface. The third inclined surface 25 slopes upward from the free end of the one-way valve 24 towards the hinged end. The one-way valve 24 can only flip downwards in one direction. After flipping, it is completely housed in a pre-set groove in the inner wall of the sampling chamber 103, without occupying channel space. It is limited by the cavity wall in the upward direction and cannot flip. When the inner core assembly 2 slides down into the sampling chamber 103, the top outer wall of the housing 10 abuts against the third inclined surface 25 of the one-way valve 24. Under the action of thrust, the one-way valve 24 flips downwards and opens, allowing the inner core assembly 2 to pass smoothly and reach the designated position. After reaching the position, the one-way valve 24 rebounds upwards under its own elasticity and resets, re-sealing the upper channel of the sampling chamber 103. A fourth inclined surface is machined on the top of the housing 10 corresponding to the position of the one-way valve 24. The fourth inclined surface matches the angle of the third inclined surface 25 at the bottom of the one-way valve 24 and fits in place, forming a bidirectional inclined surface limiting structure. When medical staff pull the lifting rope 23 outward, the lifting rope 23 drives the lifting block 21 to slide upward along the sampling chamber 103. The second inclined surface 22 of the lifting block 21 pushes upward against the first inclined surface 20 at the bottom of the housing 10. Under the squeezing action of the inclined surface, the inner core assembly 2 slides upward as a whole. When the inner core assembly 2 moves to the position of the one-way valve 24, the fourth inclined surface at the top of the housing 10 and the third inclined surface 25 at the bottom of the one-way valve 24 abut against each other. Since the one-way valve 24 cannot be flipped upward, under the guidance of the contact between the third inclined surface 25 and the fourth inclined surface and the squeezing force, the inner core assembly 2 generates a lateral displacement in the horizontal direction, passes through the through channel between the sampling chamber 103 and the sampling chamber 102 and enters the interior of the sampling chamber 102, completing the chamber switching.

[0031] In practice, the drive control component 4 is installed inside the operating cavity 101 of the outer cannula needle body 1. The entire drive control component 4 is confined inside the operating cavity 101. Its transmission end extends into the sampling cavity 103 through the sealing partition between the operating cavity 101 and the sampling cavity 103, and forms a transmission abutment with the upper end of the inner core component 2. Medical staff can apply manual pressure through the drive control component 4 to drive the inner core component 2 to complete the complete sampling action such as axial downward pressing, transmission execution, and reset retraction.

[0032] In specific implementation, a sampling structure 32 is assembled inside the sampling cavity 102 of the outer tube needle body 1. The sampling structure 32 is used to receive the inner core component 2 that is laterally moved into the sampling cavity 102 from the sampling cavity 103, and to stably remove it from inside the outer tube needle body 1.

[0033] In practical implementation, the needle tip of the outer tube needle body 1 has a sealing and opening / closing structure that cooperates with the side sampling port 3. This structure includes a drive structure 5, a spiral track 6, a reset spring 7, and a columnar movable plate. The drive structure 5 is slidably fitted inside the needle tip, and the bottom of the drive structure 5 abuts against the reset spring 7. The reset spring 7 is a compression spring that pushes the drive structure 5 upward under normal conditions, keeping it in its initial high position and achieving automatic reset. The inner wall of the needle tip is machined with a spiral track 6, which is a continuously tapered curved groove. The groove is spirally arranged upward with the axis of the outer tube needle body 1. The outer wall of the drive structure 5 is slidably fitted with the spiral track 6. When the inner core assembly 2 presses the drive structure 5 downward, the drive structure 5 overcomes the elastic force of the reset spring 7 and moves downward along the spiral track 6. While moving downward, it also rotates circumferentially. The movement trajectory is uniquely defined by the spiral track 6, without deviation or jamming. The top of the drive structure 5 is fixedly connected to a columnar movable plate, which is an arc-shaped plate structure with the same curvature as the inner wall of the needle tip. In the initial state, the columnar movable plate completely covers and blocks the side sampling port 3, keeping the needle tip completely sealed and ensuring a smooth and safe puncture process. When the drive structure 5 is pressed down and rotates along the spiral track 6, it simultaneously drives the columnar movable plate to rotate circumferentially, gradually aligning the preset notch on the columnar movable plate with the side sampling port 3. When it rotates to the preset angle, the notch and the side sampling port 3 are completely connected, the needle tip seal is released, and an open tissue entry channel is formed. After the inner core component 2 is reset, the drive structure 5 returns to its original position along the spiral track 6 under the action of the reset spring 7 and rotates in the opposite direction. The columnar movable plate rotates synchronously to reseal the side sampling port 3, restoring the sealed state.

[0034] In specific implementation, the drive control component 4 inside the operating cavity 101 of the outer tube needle body 1 is an elastic pressing transmission structure, which includes an elastic rod 27, a top pressure spring 28, a contact rod 29, and a return spring 7. The elastic rod 27 is arranged axially along the operating cavity 101, and its top abuts against the top pressure spring 28 between the top of the elastic rod 27 and the upper inner wall of the operating cavity 101. The top pressure spring 28 is a compression spring, which pushes the elastic rod 27 to a high position under normal conditions. The inner wall of the operating cavity 101 is provided with an axial guide channel, which restricts the elastic rod 27 to slide only along the axial direction and prevents it from deviating radially. The contact rod 29 is horizontally slidably assembled at the bottom of the elastic rod 27. The end face of the horizontal section is machined with a fifth inclined surface, which slopes upward from the inside to the outside of the elastic rod 27. A corresponding matching inclined surface 31 is provided at the bottom of the elastic rod 27, which slides in contact with the fifth inclined surface. A return spring 7 is provided between the contact rod 29 and the elastic rod 27, so that the contact rod 29 is kept in the retracted position under normal conditions. A sealing through hole is provided in the partition between the operating chamber 101 and the sampling chamber 103 for the vertical section of the abutment rod 29 to pass through. When medical staff press down on the elastic rod 27, the elastic rod 27 moves downward against the elastic force of the top pressure spring 28. The bottom of the elastic rod 27, in conjunction with the inclined surface 31, slides relative to the fifth inclined surface of the abutment rod 29. Under the guidance of the inclined surface, the abutment rod 29 is pushed to move horizontally outward. The vertical section of the abutment rod 29 passes through the sealing through hole and enters the sampling chamber 103, and is stably abutted against the top of the driving member 9 of the inner core assembly 2. Continuing to press down on the elastic rod 27 will drive the driving member 9 to move downward, providing stable downward pressure for the inner core assembly 2. After the pressing pressure is released, the elastic rod 27 returns to its original position upward under the action of the top pressure spring 28, and the abutment rod 29 returns to its original position inward under the action of the return spring 7, disengaging from the abutment relationship with the driving member 9, without affecting the subsequent displacement and removal of the inner core assembly 2.

[0035] In specific implementation, the sampling structure 32 is assembled inside the sampling chamber 102 of the outer cannula needle body 1. The sampling structure 32 is an integral L-shaped component, including a horizontal bearing section and a vertical lifting section. The horizontal bearing section slides against the bottom of the sampling chamber 102 to support the inner core component 2 entering the sampling chamber 102. The vertical lifting section extends upward to the outside of the outer cannula needle body 1 for the operator to hold and lift. After the inner core component 2 enters the sampling chamber 102 laterally from the sampling chamber 103, it falls onto the horizontal bearing section of the sampling structure 32 under its own weight, remaining stable and without shaking. The operator can then pull the vertical lifting section upwards to remove the inner core component 2 completely and smoothly from the sampling chamber 102. The entire removal process is contactless, pollution-free, and without sample damage. After removal, a new inner core component 2 can be directly inserted into the sampling chamber 103, and the next sampling operation can be repeated. The entire process does not require moving the outer cannula needle 1 or re-puncturing and repositioning, greatly simplifying the operation process and reducing patient pain and the risks of bleeding, infection, and tissue damage. At the same time, it ensures that the sampling positions are highly consistent across multiple samplings, and that the samples are complete and reliable, meeting the requirements for sample quantity and quality for multiple pathological tests such as light microscopy, immunofluorescence, and electron microscopy.

[0036] In this embodiment, all sliding surfaces, inclined surfaces, and hinge points are treated with medical-grade smoothness, resulting in a low coefficient of friction, smooth operation, no jamming, and no noise. All elastic components are made of medical-grade stainless steel or nickel-titanium alloy, ensuring stable elasticity, fatigue resistance, and corrosion resistance, guaranteeing reliable reset after multiple sampling operations. All sealing structures employ flexible sealing or surface sealing, preventing liquid leakage and gas leakage. The inner core component 2 is independently sterile packaged for single use, avoiding cross-infection. The entire device is purely mechanically driven, with no electrical components, featuring a simple structure, low processing cost, strong stability, and intuitive operation. It is fully adaptable to the actual clinical application scenarios of renal biopsy, possessing outstanding technical advantages and broad application value.

[0037] Operating steps Preoperative preparation and inner core pre-assembly. The sterile packaged inner core assembly 2 is inserted downwards along the upper opening of the sampling chamber 103 of the outer cannula needle body 1. The inner core assembly 2 slides axially along the guide groove on the inner wall of the sampling chamber 103. The top of the housing 10 abuts against the third inclined surface 25 of the one-way valve 24 and pushes the one-way valve 24 to flip downwards. After the inner core assembly 2 descends to the preset position, the one-way valve 24 rebounds and closes, completing the inner core pre-assembly. At this time, the sampling port 3 on the side of the front end of the outer cannula needle body 1 is in a sealed state with the columnar movable plate completely blocked.

[0038] Puncture localization. Under ultrasound guidance, the medical staff holds the tail of the outer cannula needle body 1 and inserts it through the skin and muscle layer to the target sampling area of ​​the kidney. After confirming that the needle tip is in the correct position, the outer cannula needle body 1 is kept completely fixed without any displacement or rotation in preparation for subsequent sampling.

[0039] Sampling is initiated by medical personnel pressing down on the drive control component 4 outside the operating chamber 101. The elastic rod 27 moves downward along the axial guide channel, pushing the abutment rod 29 to extend horizontally and abut against the top drive component 9 of the inner core component 2. The drive component 9 slides downward under pressure, causing the internal drive structure 5 of the needle tip to move downward and rotate along the spiral track 6, causing the columnar movable plate to rotate and expose the notch, opening the side sampling port 3. On the other hand, the inclined slide 15 at the bottom of the drive component 9 pushes the L-shaped transmission rod 14 to move horizontally, deforming the rubber diaphragm 11 to compress the second chamber 13 and expand the first chamber 12 to form a negative pressure. At the same time, the guide block moves along the spiral track 6, causing the arc-shaped door 16 to rotate and open. The opening of the first chamber 12 is aligned with the side sampling port 3, and the kidney tissue is drawn into the first chamber 12 under the negative pressure.

[0040] Tissue cutting and repositioning. Medical staff slowly release the drive control component 4, which moves upward and resets under the action of the top pressure spring 28. The abutment rod 29 retracts, and the drive component 9 of the inner core component 2 rises upward under the action of its own spring. The arc-shaped door 16 rotates in the opposite direction and closes. The edge of the door and the cutting blade 17 form a shearing engagement, cutting the kidney tissue flat. The sample is sealed in the first chamber 12. At the same time, the needle tip drive structure 5 rotates upward under the action of the reset spring 7, and the columnar movable plate re-seals the side sampling port 3, restoring the needle tip seal.

[0041] Inner core displacement. Medical staff slowly pull the lifting rope 23 outward, and the lifting rope 23 drives the lifting block 21 to slide upward along the sampling chamber 103. The second inclined surface 22 of the lifting block 21 pushes the first inclined surface 20 at the bottom of the inner core assembly 2 housing 10, causing the inner core assembly 2 to move upward. The fourth inclined surface at the top of the inner core assembly 2 comes into contact with the third inclined surface 25 at the bottom of the one-way valve 24. Under the squeezing and guiding action of the inclined surfaces, the inner core assembly 2 passes laterally through the through channel into the sampling chamber 102 and falls onto the horizontal bearing section of the sampling structure 32.

[0042] Core removal. Medical staff hold the vertical lifting section of the sampling structure 32 and pull it upward to completely remove the core component 2 containing the sample from the sampling chamber 102, completing one sampling and sample collection. The removal process does not touch the sample or contaminate the channel.

[0043] Repeated sampling is performed. The new sterile inner core assembly 2 is reinserted along the sampling cavity 103, and the above steps are repeated. Multiple consecutive samplings can be performed without moving the outer cannula needle 1 or repeating punctures, until multiple samples that meet the requirements for pathological testing are obtained.

[0044] The needle is then removed to complete the procedure. After all samples have been collected, the outer cannula needle body 1 is slowly and steadily withdrawn from the body. Routine pressure is applied to the puncture site to stop bleeding. The device is now in use, and the inner core component 2 is disposed of as disposable medical waste.

[0045] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. 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 puncture needle device for nephrology, characterized in that, include: The outer tube needle body (1) is an integral hollow tubular structure, and its interior is provided with independent sampling chambers (103) and sampling cavity (102) along the length direction. The inner core assembly (2) is detachably coaxially assembled inside the sampling chamber (103) for performing tissue acquisition, cutting and containment; The drive control component (4) is movably mounted on the outer tube needle body (1) and is in transmission cooperation with the inner core component (2) to provide driving force to the inner core component (2) to complete the sampling action; The sampling structure (32) is movably set inside the sampling cavity (102) and is used to receive and take out the inner core component (2) after sampling is completed.

2. The nephrology puncture needle device according to claim 1, characterized in that, The front end of the outer cannula needle body (1) is provided with a puncture needle (18), the side wall of the puncture needle (18) is provided with a side sampling port (3), and the inside of the puncture needle (18) is provided with a sealing opening and closing structure that cooperates with the side sampling port (3). The sealing opening and closing structure includes a drive structure (5), a spiral track (6), a return spring (7), and a columnar movable plate; The spiral track (6) is set on the inner wall of the puncture needle (18). The drive structure (5) slides with the spiral track (6). When the drive structure (5) is pressed down by the inner core assembly (2), the drive structure (5) rotates while moving downward along the spiral track (6). The columnar movable plate is fixedly connected to the driving structure (5) and is used to selectively open or block the side sampling port (3) under the drive of the driving structure (5). The reset spring (7) is used to drive the drive structure (5) to reset.

3. The nephrology puncture needle device according to claim 1, characterized in that, The inner core assembly (2) includes: The housing (10) is divided into a first chamber (12) and a second chamber (13) by a flexible rubber diaphragm (11). The first chamber (12) is provided with a sampling opening for tissue entry. The driving component (9) is elastically assembled to the upper end of the housing (10) and can slide axially back and forth relative to the housing (10); The transmission rod (14) is connected at one end to the rubber diaphragm (11) and at the other end to the drive member (9). When the drive member (9) slides down, the transmission rod (14) is driven to move, causing the rubber diaphragm (11) to deform, thereby expanding the volume of the first chamber (12) to form a negative pressure. The arc-shaped door (16) is movably assembled at the sampling opening and is connected to the drive component (9) for transmission. When the drive component (9) slides down, the arc-shaped door (16) is driven to rotate to open the sampling opening.

4. The nephrology puncture needle device according to claim 3, characterized in that, The inner core assembly (2) also includes a cutting blade (17) which is located at the edge of the sampling opening. When the arc-shaped door (16) is closed, the edge of the arc-shaped door (16) and the cutting blade (17) form a shearing engagement to cut the tissue sucked into the first chamber (12).

5. The nephrology puncture needle device according to claim 1, characterized in that, The sampling chamber (103) is equipped with a one-way valve (24) and a lifting assembly; The one-way valve (24) is an elastic flap structure, hinged to the upper inner wall of the sampling chamber (103), and can only be flipped downwards; The lifting assembly includes a lifting block (21) and a lifting rope (23). The lifting block (21) is axially slidably disposed at the lower part of the sampling chamber (103). One end of the lifting rope (23) is connected to the lifting block (21), and the other end extends to the outside of the outer cannula needle body (1). The bottom of the inner core assembly (2) and the lifting block (21) are provided with mutually cooperating inclined surfaces, and the top of the inner core assembly (2) and the one-way valve (24) are provided with mutually cooperating inclined surfaces; When the lifting rope (23) is pulled upward, the lifting block (21) pushes the inner core assembly (2) upward through the inclined surface, and the inclined surface at the top of the inner core assembly (2) abuts against the inclined surface of the one-way valve (24), thereby driving the inner core assembly (2) to move laterally from the sampling chamber (103) to the sampling chamber (102).

6. The nephrology puncture needle device according to claim 1, characterized in that, The drive control assembly (4) includes an elastic rod (27), an abutment rod (29), and a top pressure spring (28). The elastic rod (27) is slidably disposed in the operating cavity (101) of the outer tube needle body (1) along the axial direction, and the top pressure spring (28) is used to drive the elastic rod (27) to reset; The abutment rod (29) is horizontally slidably disposed at the bottom of the elastic rod (27), and a return spring (7) is provided between the abutment rod (29) and the elastic rod (27). The horizontal section of the abutment rod (29) and the bottom of the elastic rod (27) are provided with mutually cooperating inclined surfaces. When the elastic rod (27) is pressed down, the inclined surfaces drive the abutment rod (29) to extend horizontally to abut against the inner core assembly (2).

7. The nephrology puncture needle device according to claim 1, characterized in that, The sampling structure (32) is an L-shaped component, including a horizontal bearing section and a vertical lifting section. The horizontal bearing section slides against the bottom of the sampling cavity (102) to support the inner core assembly (2), and the vertical lifting section extends upward to the outside of the outer tube needle body (1).

8. A sampling method using the nephrology puncture needle device according to any one of claims 1-7, characterized in that, Includes the following steps: Puncture positioning: Insert the outer cannula needle body (1) into the target position and keep it fixed; Drive sampling: Operate the drive control component (4) to drive the pre-installed inner core component (2) to open the side sampling port (3) and draw the tissue into the inner core component (2); Cutting and Resetting: Cancel the operation of the drive control component (4), reset the inner core component (2) and cut the tissue, and close the side sampling port (3). Core displacement: Operate the lifting assembly to move the core assembly (2) containing the tissue sample axially and laterally to the sampling chamber (102) under the action of the guide structure. Core removal: The core assembly (2) located in the sampling cavity (102) is removed by means of the sampling structure (32).

9. The sampling method according to claim 8, characterized in that, It also includes a core replacement step: after removing the core assembly (2) loaded with tissue samples, a new core assembly (2) is installed into the sampling chamber (103). Without moving the outer cannula needle body (1), the steps of driving sampling, cutting reset, core displacement and core removal are repeated to achieve multiple continuous sampling.

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