Blood vessel puncture needle with anti-blocking side hole and arc-shaped side edge

Abstract

The utility model provides a blood vessel puncture needle with an anti-blocking side hole and an arc-shaped side edge. The blood vessel puncture needle comprises a needle tube, a needle tip arranged at the far end of the needle tube and a needle base arranged at the near end of the needle tube. An arc-shaped side blade is arranged on the tube wall of the needle tube; the tube wall of the needle tube is a smooth guide section between the needle tip and the arc-shaped side edge; a side hole is formed in the tube wall of the smooth guide section, and the hole edge of the side hole is lower than the tube wall of the needle tube. Through the design of the side hole, the needle seat end can still provide a blood return signal after the opening of the needle tip is blocked, and the needle tip is prevented from puncturing the rear wall of a blood vessel.

Description

Technical Field

[0001] This utility model relates to the field of puncture needle technology, and in particular to a vascular puncture needle with an anti-clogging side hole and an arc-shaped side blade. Background Technology

[0002] Percutaneous vascular puncture is a crucial step in interventional diagnosis and treatment, and its safety, controllability, and success rate directly affect subsequent procedures.

[0003] To reduce puncture resistance, various puncture needle designs with lateral cutting edges on the needle tube wall exist in the prior art. For example, Chinese invention patent application CN110384546A discloses a puncture needle with a cutting edge, where the lateral cutting edge extends to the vicinity of the needle tip and is continuous with the needle tip area. However, this design poses significant safety hazards in vascular puncture applications: the moment the needle tip pierces the blood vessel lumen, the lateral cutting edge, being equally sharp and closely following the needle tip, may immediately contact the blood vessel wall and cut it. At this point, if the operator fails to stop advancing instantly due to unclear tactile feedback or operational inertia, the needle tip can easily continue to advance under the synergistic cutting action of the lateral cutting edge, thereby penetrating the relatively thin posterior wall of the blood vessel, causing transmural damage, and potentially inducing complications such as hematoma and pseudoaneurysm. Utility Model Content

[0004] The purpose of this invention is to address the shortcomings of existing technologies by providing a vascular puncture needle with an anti-clogging side hole and an arc-shaped side blade on the back.

[0005] To achieve the above objectives, this utility model provides the following technical solution:

[0006] A vascular puncture needle with an anti-clogging side hole and an arc-shaped side blade includes a needle tube, a needle tip located at the distal end of the needle tube, and a needle seat located at the proximal end of the needle tube.

[0007] The tube wall of the needle is provided with an arc-shaped side blade;

[0008] Between the needle tip and the arc-shaped side blade, the tube wall is a smooth guide section;

[0009] A side hole is provided on the wall of the smooth guide section, and the edge of the side hole is lower than the wall of the needle tube.

[0010] In a preferred embodiment, the cutting edge height of the arc-shaped side blade increases non-linearly from its starting end to its proximal end.

[0011] In a preferred embodiment, the starting end of the arc-shaped side blade smoothly transitions to the wall of the needle tube.

[0012] In a preferred embodiment, the length of the smooth guide section is 1.0 mm to 3.0 mm.

[0013] In a preferred embodiment, the side hole is located at the 12 o'clock, 3 o'clock, or 9 o'clock position around the needle tube, and the two arc-shaped side blades are located on the same horizontal plane and are perpendicular to the axis of the side hole located at the 12 o'clock position.

[0014] In a preferred embodiment, the needle tip has a bevel;

[0015] The side hole is located circumferentially on the needle tube, and its angular position is the same as the orientation of the bevel of the needle tip.

[0016] In a preferred embodiment, the number of the arc-shaped side blades is two, and the two arc-shaped side blades are evenly spaced along the circumference of the smooth guide section.

[0017] In a preferred embodiment, the diameter of the side hole is 0.3 mm to 0.5 mm.

[0018] In a preferred embodiment, the arc-shaped side blade is welded to the needle tube wall.

[0019] Compared with existing technologies, this technical solution has the following advantages:

[0020] Even in the common situation where the needle tip is close to the blood vessel wall, causing poor blood return in the main pathway, the side holes on the smooth guide section of the tube wall, which form an auxiliary pathway with the inner lumen of the needle tube, can still provide blood return signals at the needle hub end, indicating the status of the needle tip entering the blood vessel lumen and reducing the risk of accidental deep insertion.

[0021] Because the edge of the side hole is located in a recessed structure below the outer surface of the needle tube, it can effectively reduce tissue scraping during puncture, greatly reducing the probability of tissue debris blocking the side hole or lumen, and ensuring the immediate patency and reliability of the auxiliary blood return pathway when needed.

[0022] The height of the curved side blade increases non-linearly and gradually from the starting end, with a smooth transition between the starting end and the needle tube. This design transforms the subcutaneous tissue cutting process from the abrupt load impact of a traditional straight blade to a continuous and gradual load change, allowing the needle tip to enter the blood vessel more smoothly and controllably. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of the vascular puncture needle with anti-clogging side hole and arc-shaped side blade of the present invention;

[0024] Figure 2 This is a schematic diagram of the arc-shaped side blade of the present invention;

[0025] Figure 3 This is a schematic diagram of the structure of the present invention with the side hole located at the 12 o'clock position;

[0026] Figure 4 This is a schematic diagram of the structure of the present invention with the side hole located at the 3 o'clock position;

[0027] Figure 5 This is a schematic diagram of the structure of the side hole of this utility model located at the 9 o'clock position.

[0028] In the diagram: 1. Needle seat, 2. Needle tube, 3. Arc-shaped side blade, 4. Smooth guide section, 5. Side hole, 6. Needle tip, 61. Bevel. Detailed Implementation

[0029] The following description is intended to disclose the present invention so that those skilled in the art can implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art. The basic principles of the present invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the present invention.

[0030] Please refer to Figure 1 and Figure 3 The present invention provides a vascular puncture needle with an anti-clogging side hole and an arc-shaped side blade, including a needle tube 2, a needle tip 6 disposed at the distal end of the needle tube 2, and a needle seat 1 disposed at the proximal end of the needle tube 2.

[0031] The tube wall of the needle tube 2 is provided with an arc-shaped side blade 3;

[0032] Between the needle tip 6 and the arc-shaped side blade 3, the wall of the needle tube 2 is a smooth guide section 4;

[0033] A side hole 5 is provided on the tube wall of the smooth guide section 4, and the edge of the side hole 5 is lower than the tube wall of the needle tube 2.

[0034] As the needle tip 6 penetrates the skin and continues to advance, following the axial structural sequence of needle tip 6 – smooth guide section 4 – arc-shaped side blade 3, the needle tip 6 first punctures the skin. Then, the smooth guide section 4, acting as a guide segment, enters the tissue, its surface devoid of any cutting edges 31, providing only a smooth transition. Immediately following, the arc-shaped side blade 3, located behind the smooth guide section 4, begins to contact and act on the skin and subcutaneous tissue. The height of the cutting edge 31 of this arc-shaped side blade 3 increases non-linearly and gradually from the initial end to the proximal end, and its initial end smoothly transitions to the wall of the needle tube 2, resulting in a gradual change in resistance during the cutting and separation process of the tissue. This assists the needle tip 6 in more smoothly and controllably penetrating the blood vessel lumen.

[0035] When the needle tip 6 penetrates the anterior wall of the blood vessel and enters the blood vessel lumen, the smooth guide segment 4 immediately follows and partially enters the blood vessel. At this time, the operator can observe a blood return signal at the needle hub 1. This signal may come from the main pathway of the needle tip 6, or from the auxiliary pathway provided by the side hole 5 located on the smooth guide segment 4 when the main pathway is obstructed due to reasons such as apposition to the vessel wall. According to the principle of stopping bleeding immediately, the operator can immediately immobilize the needle. This avoids the needle tip penetrating the posterior wall of the blood vessel, significantly reducing the risk of transmural damage and related complications.

[0036] Meanwhile, the edge of the side hole 5 is located in a recessed structure below the outer surface of the needle tube 2, which can effectively reduce tissue scraping during puncture and greatly reduce the probability of tissue debris blocking the side hole 5 or the lumen, ensuring the immediate unobstructed and reliable auxiliary blood return pathway when needed, and further improving the certainty of the cavity entry judgment.

[0037] like Figure 1 As shown, the distal end of the needle tube 2 is connected to the needle tip 6, which is used to pierce the blood vessel wall and enter the blood vessel lumen. The proximal end of the needle tube 2 is connected to the needle hub 1, which is located outside the body during operation. The distal end of the needle tube 2 faces the patient, and the proximal end of the needle tube 2 faces the operator.

[0038] The needle hub 1, the needle tube 2, and the needle tip 6 are all hollow structures, and their internal cavities are interconnected, forming the main pathway for blood return.

[0039] The needle hub 1 can be made of medical polymer materials (such as polycarbonate, ABS, etc.) or metal, and it is fixedly connected to the proximal end of the needle tube 2 through reliable medical connection methods such as sleeve or adhesive.

[0040] The needle tube 2 and the needle tip 6 are preferably made of medical-grade metal tubing (such as 304 or 316L stainless steel) through an integral molding process.

[0041] Specifically, such as Figures 3 to 5 As shown, the processing methods for the needle tube 2 and the needle tip 6 are as follows:

[0042] A section of medical-grade stainless steel tubing (such as 304 or 316L stainless steel) is selected as the blank. The distal end is shaped by grinding to produce a needle tip 6 with a bevel 61, the angle of which is preferably 18° to 20°.

[0043] A tube segment with a length of 1.0 mm to 3.0 mm is reserved behind the needle tip 6 (i.e., in the direction close to the needle seat 1). The reserved tube segment is deburred to obtain a smooth guide section 4. At the same time, the bevel of the needle tip 6 can also be deburred.

[0044] like Figure 1 , Figures 3 to 5 As shown, a side hole 5 is provided on the wall of the smooth guide section 4. To achieve the anti-clogging function, the edge of the side hole 5 (the edge of the orifice) is lower than the wall of the needle tube 2. The side hole 5 communicates with the internal cavity of the needle tube 2, forming an auxiliary passage.

[0045] Specifically, the outer wall of the smooth guide section 4 is provided with a recessed structure. This recessed structure is preferably disc-shaped, with a depth of approximately 0.05 mm to 0.1 mm. The depth of the recessed structure refers to the distance from the bottom of the recessed structure to the pipe wall.

[0046] The side hole 5 is located at the center of the bottom surface of this recessed structure. Therefore, the edge of the side hole 5 is recessed relative to the wall of the needle tube 2, which significantly reduces the risk of the edge of the side hole 5 directly scraping the tissue in the puncture path.

[0047] The recessed structure and the side hole 5 are formed using the following manufacturing process:

[0048] First, a side hole 5 is formed on the smooth guide section tube wall using a laser drilling process. The diameter of the side hole 5 is 0.3 mm to 0.5 mm.

[0049] Subsequently, a dish-shaped recessed structure can be formed around the side hole 5 through processes such as local micro-stamping, micro-forming, or electrochemical corrosion, thereby completing the fabrication of the recessed structure and the side hole 5.

[0050] refer to Figures 3 to 5 The number of side holes 5 is three, which are evenly spaced along the circumference of the smooth guide section 4. Specifically, they are oriented towards the 12 o'clock, 3 o'clock and 9 o'clock directions, respectively.

[0051] The two arc-shaped side blades 3 are located on the same horizontal plane and are perpendicular to the axis of the side hole 5 located at the 12 o'clock position.

[0052] like Figure 1 and Figure 2 As shown, the arc-shaped side blade 3 is fixedly mounted on the wall of the needle tube 2. The height of its cutting edge 31 gradually increases non-linearly from its starting end along the axial direction of the needle tube 2 towards the proximal end (i.e., towards the needle hub 1). The height of the cutting edge 31 refers to the vertical distance from the outer edge of the arc-shaped side blade 3 to the surface of the needle tube 2 wall. The starting end of the arc-shaped side blade 3 refers to the end that first contacts the skin during needle puncture.

[0053] As can be seen, the profile of the cutting edge 31 of the arc-shaped side blade 3 is designed to be convex and streamlined (approximately shark fin-shaped). Its starting end and the surface of the needle tube 2 are processed through post-weld shaping, grinding, and polishing to form a continuous and smooth transition, without any sharp edges or steps, ensuring that the initial tangent angle at this point is less than 10°. This design effectively reduces stress concentration and smoothly guides and changes the direction of force on the tissue during puncture, thereby minimizing the sudden increase in resistance when the cutting edge 31 begins to contact the tissue.

[0054] The non-linear, gradually increasing height of the blade 31 ensures that the arc-shaped side blade 3, when piercing the skin and subcutaneous tissue, presents a continuous and gradual cutting action, progressing from nothing to something, and from small to large. This design transforms the load required for tissue cutting and separation from the instantaneous impact generated by traditional straight or abrupt side blades into a smooth, continuously varying force.

[0055] like Figure 1 and Figure 2 As shown, the number of the arc-shaped side blades 3 can be two, with the two arc-shaped side blades 3 evenly spaced along the circumference of the smooth guide section 4, facing the 3 o'clock and 9 o'clock directions respectively. The symmetrical arc-shaped side blades 3 provide a balanced lateral force when cutting subcutaneous tissue, effectively preventing uncontrollable rotation or deflection of the puncture needle during puncture, thereby further improving the straightness and stability of the puncture.

[0056] The arc-shaped side blade 3 is manufactured and fixed to the needle tube 2 using the following process:

[0057] First, stainless steel or other biocompatible metal materials are processed into arc-shaped side blades 3 using processes such as laser cutting, punching, or grinding. The profile of the cutting edge 31 of the arc-shaped side blade 3 can be processed and controlled according to a preset asymptotic curve (for example, by fitting a parabolic function y=ax²) to ensure that the height of the cutting edge 31 exhibits the required non-linear increasing pattern.

[0058] The machined arc-shaped side blade 3 is positioned on the wall of the needle tube 2 using a clamp. After positioning, it is firmly fixed to the outer surface of the needle tube 2 using a welding process (such as laser welding, micro resistance welding, or brazing).

[0059] After welding, the welded joint area undergoes post-treatment such as shaping, grinding, and polishing. This aims to completely eliminate any weld slag, protrusions, or micro-steps that may be generated during welding, ensuring a smooth, continuous, and rounded transition between the starting end of the arc-shaped side blade 3 and the surface of the needle tube 2 wall, and completely avoiding any sharp edges, steps, or burrs that may scratch the tissue or cause sudden changes in resistance.

[0060] The puncture needle obtained above is then subjected to electrolytic polishing and passivation treatment to ensure that the surface is continuous, smooth and free of microburrs.

[0061] The method of using the vascular puncture needle with anti-clogging side holes and arc-shaped side blades is as follows:

[0062] S1, Positioning puncture

[0063] The operator places the bevel of the needle tip 6 above the target blood vessel (usually at the 12 o'clock position) and inserts it into the skin at a standard percutaneous puncture angle (e.g., 30°~45°).

[0064] S2, Controlled Tissue Penetration

[0065] Maintain a steady force and direction as you advance the puncture needle. During the puncture process, the needle is applied to the tissue in the following structural sequence: needle tip 6 – smooth guide section 4 – curved side blade 3.

[0066] The needle tip 6 first pierces the skin;

[0067] Subsequently, the smooth guide section 4 enters, providing low-resistance guidance;

[0068] Next, the curved side blade 3 located at the rear begins to progressively cut and separate the skin and subcutaneous tissue. Due to the highly non-linearly increasing and smooth contour of its blade edge 31, it effectively reduces sudden changes in resistance, providing the operator with a smooth and linear tactile feedback, enabling precise control of the needle insertion depth and speed, and allowing the needle tip 6 to smoothly approach the target blood vessel.

[0069] S3. Assessment of blood vessel entry into the lumen and blood return

[0070] When the needle tip 6 penetrates the anterior wall of the blood vessel and enters the blood vessel lumen:

[0071] If the opening at needle tip 6 is unobstructed, blood will immediately flow back through the main pathway, forming visible blood return at needle hub 1.

[0072] If the opening of the needle tip 6 is close to the blood vessel wall, causing obstruction of the main passage, the side hole 5 on the smooth guide section 4 located in the blood vessel lumen will be immediately activated as an auxiliary passage, through which blood flows in, and the operator can also observe a clear and stable blood return signal at the needle hub 1.

[0073] S4. Safety Braking and Confirmation

[0074] Once a continuous and stable blood return signal is observed at needle hub 1, the operator should immediately stop rapid advancement. The operator may then make routine minor adjustments (such as gentle rotation or slight retraction) to optimize the position of the needle tip within the lumen.

[0075] S5. Guidewire insertion and instrument exchange

[0076] After confirming the correct needle placement, insert the guidewire through needle hub 1. Once the guidewire has successfully penetrated a certain length into the blood vessel, fix it in place and withdraw the needle along the guidewire. Finally, insert a vascular sheath or other interventional device along the guidewire to complete the establishment of the vascular access.

[0077] The smooth guide segment 4 is designed to fully comply with standard clinical arterial puncture procedures (slow, segmental advancement, real-time observation of blood return), and calculations have confirmed that it does not carry the risk of the arc-shaped side blade 3 cutting the vessel.

[0078] The smooth guide segment 4 does not include the needle tip 6. The needle tip 6 itself has a certain length, which is sufficient to cross the blood vessel wall and penetrate into the blood vessel.

[0079] When the needle tip 6 penetrates the anterior wall of the blood vessel and enters the blood vessel lumen, the smooth guide segment 4 immediately follows and partially enters the blood vessel. At this time, a blood return signal can be observed at the needle hub 1. This indicates that the blood return signal is generated at the moment when the needle tip 6 and / or the smooth guide segment 4 enter the blood vessel. At this time, the starting end of the arc-shaped side blade 3 is located behind the smooth guide segment 4 and is still in the extravascular tissue.

[0080] The length of the smooth guide section 4 is 1.0 mm to 3.0 mm. That is, at the moment when the needle tip 6 enters the blood vessel lumen and generates blood return, the starting end of the arc-shaped side blade 3 is at least 1 mm to 3 mm away from the anterior wall of the blood vessel.

[0081] As can be seen, the puncture needle in this embodiment can effectively avoid operational risks through its structural design. Even when used by an inexperienced operator, when a blood return signal is observed at the needle hub 1, the smooth guide section 4 provides a safe distance of 1.0-3.0 mm, giving the operator sufficient reaction time to complete the braking before the arc-shaped side blade 3 contacts the blood vessel wall, thereby eliminating the possibility of the arc-shaped side blade 3 cutting the blood vessel wall.

[0082] The embodiments described above are only used to illustrate the technical ideas and features of this utility model. Their purpose is to enable those skilled in the art to understand the content of this utility model and implement it accordingly. The scope of patent application of this utility model should not be limited by these embodiments. That is, any equivalent changes or modifications made in accordance with the spirit disclosed in this utility model still fall within the patent scope of this utility model.

Claims

1. A vascular puncture needle with an anti-clogging side hole and an arc-shaped side blade, characterized in that, It includes a needle tube (2), a needle tip (6) located at the distal end of the needle tube (2), and a needle seat (1) located at the proximal end of the needle tube (2); The tube wall of the needle (2) is provided with an arc-shaped side blade (3); Between the needle tip (6) and the arc-shaped side blade (3), the tube wall of the needle tube (2) is a smooth guide section (4). A side hole (5) is provided on the tube wall of the smooth guide section (4), and the edge of the side hole (5) is lower than the tube wall of the needle tube (2).

2. The vascular puncture needle with anti-clogging side holes and arc-shaped side blades as described in claim 1, characterized in that, The height of the cutting edge (31) of the arc-shaped side blade (3) increases non-linearly from its starting end to its proximal end.

3. The vascular puncture needle with anti-clogging side hole and arc-shaped side blade as described in claim 2, wherein the starting end of the arc-shaped side blade (3) smoothly transitions to the wall of the needle tube (2).

4. The vascular puncture needle with anti-clogging side holes and arc-shaped side blades as described in claim 1, wherein the length of the smooth guide section (4) is 1.0 mm to 3.0 mm.

5. The vascular puncture needle with anti-clogging side hole and arc-shaped side blade as described in claim 1, wherein the side hole (5) is located at the 12 o'clock, 3 o'clock or 9 o'clock direction of the needle tube, and the two arc-shaped side blades (3) are located on the same horizontal plane and are perpendicular to the axis of the side hole (5) located at the 12 o'clock direction.

6. The vascular puncture needle with anti-clogging side hole and arc-shaped side blade as described in claim 1, wherein the needle tip (6) has a bevel (61). The side hole (5) is located in the circumferential direction of the needle tube (2), and its angular position is the same as the orientation of the inclined surface (61) of the needle tip (6).

7. The vascular puncture needle with anti-clogging side hole and arc-shaped side blade as described in claim 1, wherein the number of arc-shaped side blades (3) is two, and the two arc-shaped side blades (3) are evenly spaced along the circumference of the smooth guide section (4).

8. The vascular puncture needle with anti-clogging side hole and arc-shaped side blade as described in claim 7, wherein the arc-shaped side blade (3) and the tube wall of the needle tube (2) are welded and fixed.

9. The vascular puncture needle with anti-clogging side hole and arc-shaped side blade as described in claim 1, wherein the diameter of the side hole (5) is 0.3 mm to 0.5 mm.

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