A percutaneous kidney puncture needle and needle core

CN122604464APending Publication Date: 2026-08-21PEKING UNIVERSITY FIRST HOSPITAL (PEKING UNIVERSITY FIRST CLINICAL MEDICAL COLLEGE) +1
View PDF 0 Cites 0 Cited by

Patent Information

Application Number
CN202610836200.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-06-10
Publication Date
2026-08-21

AI Technical Summary

Technical Problem

1、圆锥形头端穿刺针:头端为光滑圆锥结构,依赖针尖压力穿透组织,但锋利度不足,穿刺时需先使用专用破皮针切开皮肤表层,再进行后续穿刺,增加了手术步骤和患者局部创伤,且穿刺过程中对深层组织的挤压作用较强,易影响穿刺路径准确性

Benefits of technology

[0024]本发明的有益效果:本发明的针芯头端在使用过程中,扁形头端顶层平头刃可切割破皮,并利用窄刃深入软组织内部,四个顶层切削棱边紧跟作用,将组织切削分解。整个过程中,扁平的头端刃口使整个头端更加锋利,破皮后,顶层平头刃和四个顶层切削棱边共五条切削刃口共同作用,将组织切开,分散切削阻力,既减少了各个刃口所承担的压力,避免刃口损坏,也提高了切削效率。突破现有穿刺针的锋利度瓶颈,实现无需事先破皮即可直接穿透皮肤及皮下组织,简化手术流程,降低患者创伤。

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN122604464A_ABST
    Figure CN122604464A_ABST
Patent Text Reader

Abstract

The present application relates to a kind of percutaneous renal puncture needle and needle core, the end of the needle core has puncture part, the puncture part is conical, the front end of conical puncture part is provided with first upper inclined plane, first lower inclined plane, the front end of first upper inclined plane and first lower inclined plane meets to form top flat head blade, left inclined plane and right inclined plane are arranged in the left and right ends of top flat head blade, left inclined plane and right inclined plane meet with first upper inclined plane and first lower inclined plane in circumferential direction, and four top cutting edges are formed at the meeting place.The needle core of the present application can cut skin in the process of use, and utilize narrow blade to penetrate into soft tissue inside, four top cutting edges follow the action, and tissue is cut and decomposed.The flat head end blade mouth makes the whole head end more sharp, after skin breaking, top flat head blade and four top cutting edges five cutting blade mouths jointly act, disperse cutting resistance, reduce the pressure borne by each blade mouth, avoid blade mouth damage, also improve cutting efficiency.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] This invention relates to the field of surgical instruments, and more specifically to a percutaneous renal puncture needle and needle core. Background Technology

[0002] Percutaneous nephrolithotomy (PCNL) is a core minimally invasive technique in urology for treating kidney stones, hydronephrosis, and other diseases. The puncture needle, as the core surgical instrument, directly affects the efficiency, accuracy, and degree of trauma to the patient. Currently, PCNL needles used clinically are mainly divided into three categories: 1. Conical tip puncture needle: The tip has a smooth conical structure and relies on the pressure of the needle tip to penetrate the tissue. However, it is not sharp enough. When puncturing, a special skin-breaking needle must be used to cut open the skin surface first before subsequent puncture, which increases the number of surgical steps and local trauma to the patient. In addition, the compression effect on deep tissues during puncture is strong, which can easily affect the accuracy of the puncture path.

[0003] 2. Triangular tip puncture needle: The tip has three cutting edges, which improves the sharpness compared to the conical tip. However, it has structural design defects: the small number of edges leads to a concentrated cutting contact area, resulting in greater puncture resistance and making it impossible to achieve direct puncture without breaking the skin; when puncturing harder tissues or when reused in the same procedure, it is prone to slight deformation, which leads to a decrease in puncture accuracy.

[0004] 3. Beveled tip puncture needle: The tip has a single beveled structure and a single straight blade. It relies on the beveled cutting force to penetrate tissue and is commonly used for superficial punctures or auxiliary drainage. Some products attempt to improve sharpness by reducing the bevel angle, but due to the single blade design, the cutting efficiency is limited and the sharpness is insufficient, still requiring skin piercing. Furthermore, the force is concentrated on the single blade, and when puncturing deep tissues, it is prone to deviation due to uneven force, making it difficult to meet the accuracy requirements for deep positioning in percutaneous renal puncture.

[0005] The problems can be summarized as follows: 1. Cumbersome pre-puncture procedures: Existing conical, triangular, and beveled puncture needles all have insufficient sharpness, requiring pre-treatment of the skin with a piercing needle, increasing the surgical procedure steps, prolonging the operation time, and the additional puncture can easily lead to local bleeding and increased pain for the patient. 2. High puncture resistance: The conical tip relies on compression to penetrate, the triangular tip has few cutting edges, and the beveled tip has low cutting efficiency with a single cutting edge. All of these result in significant tissue resistance during puncture, which can easily lead to puncture jamming and path deviation. In particular, it may affect the accurate hit of the target renal calyx when performing kidney localization puncture. 3. Conflict between structural strength and accuracy: Traditional materials and tip structure design result in limited hardness and deformation resistance of the puncture needle. During puncture, the needle is prone to edge curling or bending due to tissue reaction force. In particular, the beveled tip has a higher risk of deviation due to uneven force, which further reduces puncture accuracy. 4. Difficulty in balancing sharpness and hardness: Some improvement solutions improve sharpness by reducing the blade angle, but this will lead to a decrease in blade strength and easy damage; increasing the material hardness may affect the processing technology, making it difficult to meet the sharpness standard. Especially as the material of the outer tube of the puncture needle, it requires both toughness and strength, which puts forward higher comprehensive requirements for the tube drawing process. This contradiction is particularly prominent in beveled and triangular puncture needles. Summary of the Invention

[0006] The purpose of this invention is to provide a percutaneous renal puncture needle with a sharp cutting edge that can directly penetrate the skin and subcutaneous tissue without prior skin puncture, and the needle core used therein.

[0007] To achieve the above objectives, the present invention provides a percutaneous renal puncture needle with the following technical solution: A percutaneous renal puncture needle includes a needle core with a puncture portion at its end. The puncture portion is conical, and a first upper inclined surface and a first lower inclined surface are provided at the front end of the conical puncture portion. The front ends of the first upper inclined surface and the first lower inclined surface intersect to form a top-layer flat-head blade. A left inclined surface and a right inclined surface are provided at the left and right ends of the top-layer flat-head blade. The left and right inclined surfaces intersect with the first upper inclined surface and the first lower inclined surface in the circumferential direction, and four top-layer cutting edges are formed at the intersection.

[0008] Furthermore, the first upper inclined surface and the first lower inclined surface are symmetrically arranged, and the left inclined surface and the right inclined surface are symmetrically arranged.

[0009] Furthermore, the angle between the first upper inclined plane and the first lower inclined plane is 5°-16°; And / or, the angle between the left and right inclined planes is 16°-30°.

[0010] Furthermore, the top-layer flat-head blade has a circular arc edge with a radius of ≤0.15mm.

[0011] Furthermore, a second upper inclined surface is provided behind the first upper inclined surface, and a second lower inclined surface is provided behind the first lower inclined surface. The second upper inclined surface and the second lower inclined surface intersect with the conical surface of the conical puncture part to form a secondary first cutting edge. The axial length of the left and right inclined surfaces exceeds the first upper inclined surface and the first lower inclined surface, and the intersection with the conical surface of the conical puncture part forms a secondary second cutting edge.

[0012] Furthermore, the second upper inclined plane and the second lower inclined plane are symmetrically arranged, and the left inclined plane and the right inclined plane are symmetrically arranged.

[0013] Furthermore, the included angle between the second upper inclined plane and the second lower inclined plane is 15°±2°.

[0014] Furthermore, the needle core is an integral piece made of medical-grade high-nitrogen austenitic stainless steel or medical-grade titanium alloy. And / or, the needle core has a titanium nitride coating or a diamond-like coating.

[0015] Furthermore, it also includes a needle tube, in which the needle core is inserted, and the gap between the two is less than or equal to 0.05 mm; And / or, it also includes a needle tube, the end of which is provided with a conical transition surface corresponding to the needle core puncture part.

[0016] To achieve the above objectives, the percutaneous renal puncture needle core of the present invention adopts the following technical solution: A percutaneous renal puncture needle core, wherein the end of the needle core has a puncture portion, the puncture portion is conical, the front end of the conical puncture portion is provided with a first upper inclined surface and a first lower inclined surface, the front ends of the first upper inclined surface and the first lower inclined surface intersect to form a top-layer flat-head blade, the left and right ends of the top-layer flat-head blade are provided with a left inclined surface and a right inclined surface, the left and right inclined surfaces intersect with the first upper inclined surface and the first lower inclined surface in the circumferential direction, and the intersection forms four top-layer cutting edges.

[0017] Furthermore, the first upper inclined surface and the first lower inclined surface are symmetrically arranged, and the left inclined surface and the right inclined surface are symmetrically arranged.

[0018] Furthermore, the angle between the first upper inclined plane and the first lower inclined plane is 5°-16°; And / or, the angle between the left and right inclined planes is 16°-30°.

[0019] Furthermore, the top-layer flat-head blade has a circular arc edge with a radius of ≤0.15mm.

[0020] Furthermore, a second upper inclined surface is provided behind the first upper inclined surface, and a second lower inclined surface is provided behind the first lower inclined surface. The second upper inclined surface and the second lower inclined surface intersect with the conical surface of the conical puncture part to form a secondary first cutting edge. The axial length of the left and right inclined surfaces exceeds the first upper inclined surface and the first lower inclined surface, and the intersection with the conical surface of the conical puncture part forms a secondary second cutting edge.

[0021] Furthermore, the second upper inclined plane and the second lower inclined plane are symmetrically arranged, and the left inclined plane and the right inclined plane are symmetrically arranged.

[0022] Furthermore, the included angle between the second upper inclined plane and the second lower inclined plane is 15°±2°.

[0023] Furthermore, the needle core is an integral piece made of medical-grade high-nitrogen austenitic stainless steel or medical-grade titanium alloy. And / or, the needle core has a titanium nitride coating or a diamond-like coating.

[0024] The beneficial effects of this invention are as follows: During use, the flat-topped blade of the needle tip can cut through the skin and penetrate deep into the soft tissue using a narrow blade. Four top-layer cutting edges follow closely, further dissecting the tissue. Throughout the process, the flat tip makes the entire tip sharper. After breaking the skin, the five cutting edges—the flat-topped blade and the four top-layer cutting edges—work together to cut the tissue, dispersing cutting resistance. This reduces the pressure on each cutting edge, preventing damage and improving cutting efficiency. This invention overcomes the sharpness limitations of existing puncture needles, enabling direct penetration of the skin and subcutaneous tissue without prior skin breaking, simplifying the surgical procedure and reducing patient trauma.

[0025] Furthermore, the bevels at the tip of the needle are symmetrically arranged to symmetrically distribute the cutting resistance, prevent the needle from deviating during puncture, and ensure the accuracy of the puncture path.

[0026] Furthermore, the angle of each bevel at the tip of the needle core is experimentally proven to ensure both the sharpness of the needle core during puncture and the strength of the needle tip, preventing deformation after multiple punctures.

[0027] Furthermore, the top-layer flat blade has a rounded edge with a radius of ≤0.15mm. This structural design reduces tissue friction and protects the blade from chipping. At the same time, the small blade angle ensures that the rounded edge does not affect its sharpness, achieving extreme sharpness to directly cut through the stratum corneum and dermis.

[0028] Furthermore, a secondary cutting edge composed of a first secondary cutting edge and a second secondary cutting edge is provided. The needle tip adopts an upper and lower variable bevel to adapt to the requirements of the needle outer diameter and cutting edge cutting angle at different puncture stages. At the same time, the formation of the cutting edge ensures that the first and second secondary cutting edges are smoothly connected to the four top cutting edges, ensuring smooth cutting. During the entire puncture process, the secondary cutting edge cuts the tissue simultaneously from four directions, dividing the tissue into four parts, further dispersing the cutting force, reducing the single cutting load, and avoiding uneven force distribution.

[0029] In addition, the second upper inclined surface 17 and the second lower inclined surface 18 are symmetrically arranged, and the left and right inclined surfaces are symmetrically arranged. The secondary cutting edge is symmetrically distributed in four directions: the upper and lower surfaces, the left and right surfaces, so as to symmetrically disperse the cutting resistance, avoid the needle core from deflecting during the puncture process, and ensure the accuracy of the puncture path.

[0030] Furthermore, the needle core is an integral component made of medical-grade high-nitrogen austenitic stainless steel or medical-grade titanium alloy; and / or, the needle core has a titanium nitride coating or a diamond-like carbon coating. By employing specialized materials combined with the aforementioned structural reinforcement design, the overall hardness and deformation resistance of the needle core can be significantly improved while ensuring biocompatibility, preventing edge damage and needle bending. This achieves a synergistic optimization of high sharpness, low puncture resistance, and high hardness.

[0031] Furthermore, the needle tube and needle core are fitted with a small gap, allowing the needle tube to provide some support for the needle core. This achieves a synergy between high hardness and deformation resistance, resolving the technical contradiction between sharpness and strength. It also prevents the needle core from deforming or bending during puncture. Attached Figure Description

[0032] Figure 1 This is a top view of the tip of the percutaneous renal puncture needle of the present invention; Figure 2 This is a front view of the tip of the percutaneous renal puncture needle of the present invention; Figure 3 This is a left view of the tip of the percutaneous renal puncture needle of the present invention; Figure 4 This is a perspective view of the tip of the percutaneous renal puncture needle of the present invention; Figure 5 This is a structural diagram of the tail section of the percutaneous renal puncture needle of the present invention.

[0033] Figure 1-5 In the middle: 1. Needle core; 11. First upper bevel; 12. First lower bevel; 13. Left bevel; 14. Right bevel; 15. Top layer flat-head blade; 16. Top layer cutting edge; 17. Second upper bevel; 18. Second lower bevel; 19. Second layer first cutting edge; 10. Second layer second cutting edge; 2. Needle tube; 21. Conical transition surface; 3. Needle core tail seat; 4. Needle core plug; 5. Needle tube tail seat. Detailed Implementation

[0034] A percutaneous renal puncture needle of the present invention, such as Figure 1-5 As shown, it includes a needle core 1 and a needle tube 2, as well as a needle core tail seat 3 and a needle tube tail seat 5. The needle core 1 is inserted into the needle tube 2 and the needle tube tail seat 5, and a needle core plug 4 is provided at the end of the needle core 1.

[0035] The specific structure of the needle core 1 is as follows: Figure 1-4 As shown, for ease of description, (the text is incomplete and cannot be translated accurately.) Figure 3Based on the reference, its horizontal direction is the left-right direction, the vertical direction is the up-down direction, and the direction perpendicular to the paper is the front-back direction. Specifically: the end of the needle core 1 has a puncture part, which is conical. The front end of the conical puncture part is provided with a first upper inclined surface 11 and a first lower inclined surface 12. The front ends of the first upper inclined surface 11 and the first lower inclined surface 12 intersect to form a top-layer flat-head blade 15. The left and right ends of the top-layer flat-head blade 15 are provided with a left inclined surface 13 and a right inclined surface 14. The left inclined surface 13 and the right inclined surface 14 intersect with the first upper inclined surface 11 and the first lower inclined surface 12 in the circumferential direction, and four top-layer cutting edges 16 are formed at the intersection.

[0036] During use, the flat-topped blade 15 of the needle core 1 of this invention can cut through the skin and penetrate deep into the soft tissue using a narrow blade. Four top-layer cutting edges 16 follow closely, further cutting and decomposing the tissue. Throughout the process, the flat-topped blade makes the entire tip sharper. After the skin is broken, the five cutting edges—the flat-topped blade 15 and the four top-layer cutting edges 16—work together to cut the tissue, dispersing cutting resistance. This reduces the pressure on each blade, preventing damage and improving cutting efficiency. This invention overcomes the sharpness bottleneck of existing puncture needles, enabling direct penetration of the skin and subcutaneous tissue without prior skin breaking, simplifying the surgical procedure and reducing patient trauma.

[0037] Furthermore, the first upper inclined surface 11 and the first lower inclined surface 12 are symmetrically arranged, and the left inclined surface 13 and the right inclined surface 14 are symmetrically arranged to symmetrically distribute the cutting resistance, avoid the needle core from deflecting during the puncture process, and ensure the accuracy of the puncture path.

[0038] In addition, the angle between the first upper inclined surface 11 and the first lower inclined surface 12 is 5°-16°; and / or the angle between the left inclined surface 13 and the right inclined surface 14 is 16°-30°. Within this angle range, both the puncture sharpness of the needle core 1 and the strength of the needle tip can be guaranteed, and deformation after multiple punctures can be avoided.

[0039] Meanwhile, the top-layer flat-head blade 15 has a rounded edge with a radius of ≤0.15mm. This structural design reduces tissue friction resistance and protects the blade from chipping. At the same time, the small blade angle ensures that the rounded edge transition does not affect its sharpness, achieving extreme sharpness to directly cut through the stratum corneum and dermis.

[0040] Furthermore, a second upper inclined surface 17 is provided behind the first upper inclined surface 11, and a second lower inclined surface 18 is provided behind the first lower inclined surface 12. The second upper inclined surface 17 and the second lower inclined surface 18 form a secondary first cutting edge 19 at the intersection with the conical surface of the conical puncture part. The axial length of the left inclined surface 13 and the right inclined surface 14 exceeds the first upper inclined surface 11 and the first lower inclined surface 12, and forms a secondary second cutting edge 10 at the intersection with the conical surface of the conical puncture part. This structural design incorporates a secondary cutting edge consisting of a first secondary cutting edge 19 and a second secondary cutting edge 10. The needle tip features an upper and lower bevel to accommodate the requirements of different puncture stages on the needle's outer diameter and the cutting angle of the cutting edge. Furthermore, the formation of the cutting edge ensures that the first secondary cutting edge 19 and the second secondary cutting edge 10 are smoothly connected to the four top-layer cutting edges 16, guaranteeing smooth cutting. Throughout the puncture process, the secondary cutting edge simultaneously cuts the tissue from four directions, dividing it into four parts, further dispersing the cutting force, reducing the load on a single cut, and avoiding uneven force distribution.

[0041] In addition, the second upper inclined surface 17 and the second lower inclined surface 18 are symmetrically arranged, and the left and right inclined surfaces are symmetrically arranged. The secondary cutting edge is symmetrically distributed in four directions: the upper and lower surfaces, the left and right surfaces, so as to symmetrically disperse the cutting resistance, avoid the needle core from deflecting during the puncture process, and ensure the accuracy of the puncture path.

[0042] Meanwhile, the included angle between the second upper inclined surface 17 and the second lower inclined surface 18 is 15°±2°. Within this angle range, both the puncture sharpness of the needle core 1 and the strength of the needle tip can be guaranteed, thus preventing deformation after multiple punctures.

[0043] Furthermore, the needle core 1 is an integral component, made of medical-grade high-nitrogen austenitic stainless steel or medical-grade titanium alloy; and / or, the needle core has a titanium nitride coating or a diamond-like carbon coating. The medical-grade high-nitrogen austenitic stainless steel has a yield strength ≥350MPa and a hardness of HRC38-42, representing a strength increase of over 30% compared to traditional 304 stainless steel. The titanium nitride coating increases the surface hardness to HV1200-1500 and reduces the coefficient of friction to below 0.1. Alternatively, the needle core 1 can be replaced with medical-grade titanium alloy (Ti6Al4V), which, through surface titanium nitride treatment (oxide film thickness 5-8μm), increases the hardness to HV800-1000, offering better biocompatibility and suitability for patients with allergies. The puncture force is approximately 10% higher than that of stainless steel, but the cost is relatively higher. Furthermore, the surface of the needle core 1 can be replaced with a diamond-like carbon (DLC) coating, reducing the coefficient of friction to below 0.08 and further lowering puncture resistance. However, this coating increases processing costs by approximately 20%, making it suitable for precision surgical procedures where smooth puncture is crucial. This approach, employing specialized materials and reinforced structural design, significantly enhances the overall hardness and deformation resistance of the needle core 1 while ensuring biocompatibility, preventing edge damage and needle bending. This achieves a synergistic optimization of high sharpness, low puncture resistance, and high hardness.

[0044] Furthermore, the needle core 1 is inserted into the needle tube 2, and the gap between them is less than or equal to 0.05 mm. Specifically, the needle tube 2 adopts a hollow circular tube structure with a uniformly distributed wall thickness of 0.15-0.25 mm and a smooth inner wall (Ra≤0.05μm). By optimizing the needle wall thickness and reducing the gap between the needle core and the needle tube, the needle tube 2 can provide a certain degree of support for the needle core 1, achieving a synergy between high hardness and deformation resistance, and resolving the technical contradiction between sharpness and strength. This prevents the needle core 1 from deforming or bending during puncture.

[0045] In addition, the end of the needle tube 2 corresponding to the puncture part of the needle core 1 is provided with a conical transition surface 21. This conical transition surface makes the outer peripheral surface of the needle core 1 and the needle tube 2 in contact with the tissue smoothly transition, reducing puncture resistance.

[0046] In addition, other design features of the present invention include: the length of the top flat-head blade 15 is set to 0.3-0.8mm.

[0047] The surface roughness Ra of the conical puncture part of the needle core 1 is ≤0.02μm. The transition between different inclined surfaces and the conical puncture part adopts an arc design with R=0.1-0.5mm to avoid stress concentration.

[0048] The outer diameter of needle tube 2 is 18-20G (commonly used clinical specifications), and the inner diameter of needle tube 2 is ≥1.0mm (to meet the requirements for guidewire passage); the wall thickness of needle tube 2 is uniformly distributed, with a thickness of 0.15-0.25mm. The hollow structure of needle tube 2 balances the lightweight design of the device with structural strength, and the smooth inner wall ensures smooth guidewire delivery.

[0049] The needle tube 2 and the needle core 1 are made of the same material, or medical high-nitrogen austenitic stainless steel can be used.

[0050] The needle core 1 is a solid cylindrical structure with a smooth outer wall and a circular runout and coaxiality with the needle tube ≤0.02mm. The solid cylindrical shape of the needle core ensures the overall structural strength, while the smooth outer wall, high coaxiality, and low circular runout ensure the overall application of the puncture needle and the smooth removal of the needle core.

[0051] The needle tube tailstock 5 is made of medical-grade polycarbonate (PC) and adopts a stepped structure. One end is equipped with a needle tube fixing hole (the hole diameter is interference-fitted with the outer diameter of the needle body), and the other end is equipped with a standard fastening port. The fastening port ensures that the relative position of the outer tube and the inner core is fixed during puncture. The surface is equipped with anti-slip texture to improve the stability of hand operation. An internal sealing groove is set. The sealing groove design inside the needle tube prevents leakage of body fluid during the operation. The tail end of the needle core 1 needs to be sealed and fixed.

[0052] Furthermore, for various size ranges of the puncture portion of the needle core 1, the present invention also selected two sets of size data for experiments to demonstrate that the size range selection of the present invention can achieve the puncture sharpness and puncture strength of the needle core 1, as shown in the table below:

[0053] In summary, the overall working principle of this invention can be described as follows: This invention can be used in conjunction with a surgical robot of a puncture surgery navigation and positioning system, or it can be used in conjunction with manual puncture by medical personnel. During the procedure, medical staff / surgical robot actuators hold the needle hub and align the cutting tip of the needle core 1 with the preset puncture point. Due to the small cutting edge angle and extremely high surface precision of the cutting edge, under conventional puncture pressure (8-12N), the end of the needle core 1 can directly cut through the skin surface and subcutaneous tissue like a flat blade, without prior skin rupture. During the puncture, five cutting edges simultaneously cut the tissue, and the four top cutting edges 16 divide the tissue into four parts. Combined with the low roughness of the conical surface and the rounded transition design, the puncture resistance is reduced by 30%-50% compared to traditional triangular and beveled puncture needles. The symmetrical structure also avoids the force deviation problem of beveled puncture needles, achieving smooth advancement. The high-nitrogen stainless steel material of the needle tube 2 and the titanium nitride coating of the needle core 1 work together to further ensure that the needle body does not bend and the cutting edge does not curl during the puncture, accurately reaching the target renal calyx. After the puncture is completed, a guide wire can be pushed through the inner cavity of the needle to carry out subsequent surgical operations.

[0054] The synergistic effect between the various structures can ultimately be summarized as follows: Minimally invasive procedures without skin puncture: The small cutting edge angle of the double-layer cutting edge at the tip of the needle core 1 and the ultra-precision machining process make its sharpness 1.5-2 times that of traditional puncture needles. It can directly penetrate the skin without prior skin puncture, reducing 1-2 surgical operation steps, shortening the operation time by 10-15 minutes, reducing the local trauma area of ​​the patient by 60%, and reducing the pain score (VAS) by 2-3 points.

[0055] Dual optimization of puncture resistance and accuracy: The double-layer cutting edge at the tip of the needle core 1 is symmetrical, the needle tube 2 has an ultra-thin wall, and the gap between the needle core 1 and the needle tube 2 is minimized. The part of the needle tube 2 corresponding to the cutting edge of the needle core 1 has a tapered bevel, which minimizes the contact area between the cutting edge and the tissue. Combined with a low-friction coating and a rounded transition design, the puncture resistance is reduced by 30%-50% compared with traditional triangular and beveled puncture needles, and the deviation problem of beveled needles is avoided. There is no jamming or deviation during the puncture process, and the target renal calyx puncture hit rate is increased to over 98% (approximately 90% with existing technology).

[0056] Improved structural strength and durability: The yield strength of high-nitrogen stainless steel is 30% higher than that of traditional materials, and the surface hardness is increased by 2-3 times after coating treatment. Even with repeated punctures, there is no edge curling or needle deformation, making it more durable than traditional puncture needles.

[0057] Significant synergistic effect: The four core properties of sharpness, low resistance, high hardness, and high precision work together to solve the multiple technical contradictions of existing puncture needles, such as "sharpness leads to easy damage, hardness leads to obstruction, and cutting leads to deviation". It realizes the clinical needs of "precise puncture + minimally invasive treatment + safety and reliability" and is suitable for various percutaneous kidney puncture surgery scenarios, especially for precise puncture of patients with complex anatomical structures.

[0058] The present invention also provides a percutaneous renal puncture needle core, the structure of which is the same as that of the needle core 1 in the percutaneous renal puncture needle described above, and will not be described in detail here.

[0059] Although this disclosure has been described and illustrated in detail in the accompanying drawings and the foregoing description, such description and illustration should be considered illustrative and suggestive, not restrictive; this disclosure is not limited to the disclosed embodiments. By studying the drawings, the disclosure, and the appended claims, those skilled in the art will be able to understand and implement variations of the disclosed embodiments in practicing the claimed subject matter. In the claims, the word "comprising" does not exclude other elements or steps not listed, and the indefinite articles "a" or "an" do not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be beneficial.

Claims

1. A percutaneous renal puncture needle, comprising a needle core, characterized in that: The end of the needle core has a puncture part, which is conical. The front end of the conical puncture part is provided with a first upper inclined surface and a first lower inclined surface. The front ends of the first upper inclined surface and the first lower inclined surface meet to form a top-layer flat-head blade. The left and right ends of the top-layer flat-head blade are provided with a left inclined surface and a right inclined surface. The left and right inclined surfaces meet with the first upper inclined surface and the first lower inclined surface in the circumferential direction, and four top-layer cutting edges are formed at the intersection.

2. The percutaneous renal puncture needle according to claim 1, characterized in that: The first upper inclined plane and the first lower inclined plane are symmetrically arranged, and the left inclined plane and the right inclined plane are symmetrically arranged.

3. The percutaneous renal puncture needle according to claim 1, characterized in that: The angle between the first upper inclined plane and the first lower inclined plane is 5°-16°; And / or, the angle between the left and right inclined planes is 16°-30°.

4. The percutaneous renal puncture needle according to claim 1, characterized in that: The top-layer flat-head blade has a circular arc edge with a radius of ≤0.15mm.

5. The percutaneous renal puncture needle according to claim 1, characterized in that: A second upper inclined surface is provided behind the first upper inclined surface, and a second lower inclined surface is provided behind the first lower inclined surface. The second upper inclined surface and the second lower inclined surface intersect with the conical surface of the conical puncture part to form a secondary first cutting edge. The axial length of the left and right inclined surfaces exceeds the first upper and first lower inclined surfaces, and the intersection with the conical surface of the conical puncture part forms a secondary second cutting edge.

6. The percutaneous renal puncture needle according to claim 5, characterized in that: The second upper inclined plane and the second lower inclined plane are symmetrically arranged, and the left inclined plane and the right inclined plane are symmetrically arranged.

7. The percutaneous renal puncture needle according to claim 5, characterized in that: The angle between the second upper inclined plane and the second lower inclined plane is 15°±2°.

8. The percutaneous renal puncture needle according to claim 1, characterized in that: The needle core is an integrated unit, made of medical-grade high-nitrogen austenitic stainless steel or medical-grade titanium alloy. And / or, the needle core has a titanium nitride coating or a diamond-like coating.

9. The percutaneous renal puncture needle according to claim 1, characterized in that: It also includes a needle tube, in which the needle core is inserted, and the gap between the two is less than or equal to 0.05 mm; And / or, it also includes a needle tube, the end of which is provided with a conical transition surface corresponding to the needle core puncture part.

10. A percutaneous renal puncture needle core, characterized in that, The percutaneous renal puncture needle core is the needle core as described in any one of claims 1-9.