Non-coring needle with reverse sharp edge
By designing a sharp edge on the heel side of the reverse needle and rounding the inner and outer surface corners, the problem of guide wire coating wear and peeling is solved, thus achieving safety and reliability of the guide wire during puncture and withdrawal.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BENTLEY INNOMED GMBH
- Filing Date
- 2021-11-08
- Publication Date
- 2026-06-05
AI Technical Summary
In existing technologies, the guidewire coating is easily worn or peeled off by the sharp edges of the needle tip during passage and withdrawal, especially when passing through calcified plaques, increasing surgical risks.
Design a non-core needle tip that avoids contact between the guide wire coating and the sharp edge by reversing the direction of the sharp edge on the needle heel side and rounding any corners or edges on the inner and outer surfaces.
It effectively prevents the guidewire coating from wearing off or peeling off during puncture and withdrawal, improving the safety and reliability of the guidewire and reducing surgical risks.
Smart Images
Figure CN116600840B_ABST
Abstract
Description
Technical Field
[0001] The present invention generally relates to a novel needle with a sharp edge designed to prevent the coated guidewire from being damaged due to coating wear or peeling. Background Technology
[0002] Chronic total occlusion (CTO) is a blockage (usually plaque) in an artery that obstructs blood flow. CTO can occur in the coronary arteries and peripheral arteries, and is usually caused by the same underlying cause—atherosclerosis.
[0003] One of the main difficulties in traversing a complete occlusion is that clinicians don't know exactly how hard the plaque is until the guidewire is guided through the occlusion. If the occlusion is relatively new, the plaque may be soft enough that the guidewire can penetrate it. However, after weeks or months, the occlusion becomes fibrotic and calcified, and the plaque becomes much harder, making it difficult, if not impossible, to traverse the occlusion. Failure to traverse the occlusion is the primary failure mode for CTO recanalization.
[0004] If the guidewire cannot pass through the occlusion, a support catheter and a perforation catheter are used to support the guidewire through the occlusion. This perforation catheter may have a blunt tip.
[0005] If endovascular recanalization of the CTO is not possible, techniques have been developed to access the subendothelial space and re-enter the true lumen after occlusion. This so-called subendothelial recanalization is a useful procedure and is widely used. One advantage of subendothelial recanalization is that incision of the subendothelial space is more likely to produce a smooth lumen and improved blood flow compared to creating a lumen through calcified plaques. However, approximately 25% of patients undergoing percutaneous subendothelial recanalization experience technical failures, primarily due to the inability to re-enter the distal true lumen.
[0006] If the true lumen cannot be re-entered via guidewire manipulation during percutaneous endoscopic recanalization, a true lumen re-entry device must be used. Several specially designed re-entry devices are currently available on the market. Most of them use a straight or curved needle to reinsert the guidewire into the true lumen after occlusion.
[0007] Most guidewires currently available are polymer-coated, sometimes hydrophilic-coated, and many have both polymer and hydrophilic coatings. This coating provides significantly less friction and better maneuverability. However, using such coated guidewires with sharp needles carries the risk of damaging the guidewire during retraction, as the sharp needle edge can cause abrasion and / or peeling of the coating. This risk is even more severe and dangerous when guidewire coating abrasion or peeling occurs inside the patient's blood vessel.
[0008] Some non-core-taking characteristics can be added to the needle tip, and are known in the art. The sharp but very thin edges of the needle heel can be slightly rounded using techniques such as gentle mechanical milling, sandblasting, or electropolishing. Due to the thin wall thickness of the needle tube, the rounding radius is very small. However, in the prior art, only the inner sharp edges of the needle are rounded, while the outer edges remain sharp to penetrate tissue or plaque. Therefore, in the prior art, the outer edges need to be masked to avoid rounding them. Summary of the Invention
[0009] This invention seeks to provide a novel needle non-coring device and its process. The non-coring needle tip of this invention allows polymer-coated and / or hydrophilic-coated guidewires to pass safely through the sharp needle tip, thereby eliminating the risk of coating abrasion or peeling caused by the sharp edge of the needle.
[0010] The non-core-sampling needle tip of the present invention can be applied to any type of needle tip and any type of catheter, or any other device containing a sharp needle. The non-core-sampling needle tip of the present invention can be a straight needle tip or a curved needle tip.
[0011] Simple, existing needles are typically made of a metal thiocyanate tube with an acute-angled bevel, usually around 20°. Sometimes, the bevel is made at two different angles, referred to as a lancet tip.
[0012] In the prior art, when the guidewire is pushed forward through a device with a beveled needle tip at the distal end, the guidewire does not encounter any sharp needle edges and can pass safely without damaging its coating. When the guidewire is pulled back into the device through the needle and encounters the very sharp edge on the heel side of the needle tip, wear or peeling of the guidewire coating occurs on the posterior or heel side of the needle tip.
[0013] The non-core-taking needle tip of this invention is based on reversing the direction of the sharp needle edge on the needle heel side. A rounding of the needle inner diameter edge can be added to the reversal of the direction of the sharp edge on the needle heel side.
[0014] In addition, any corners or edges on the inner circumference of the needle, even those with obtuse angles on the heel side and the needle puncture side, can be rounded to prevent wear or peeling of the guidewire coating. Attached Figure Description
[0015] The invention will be more fully understood and appreciated from the following detailed description, taken in conjunction with the accompanying drawings.
[0016] In the picture:
[0017] Figure 1 is a schematic diagram of the needle bevel angle in the prior art.
[0018] Figure 2 is a schematic diagram of different beveled corner pins in the prior art.
[0019] Figures 3A and 3B are schematic diagrams from two perspectives of a prior art needle tip with an outer cutting edge and an inner cutting edge.
[0020] Figures 4A and 4B are simplified schematic diagrams of mechanical removal or trimming of the sharp base of a needle in the prior art.
[0021] Figure 5A and 5B This is a schematic diagram of two perspectives of the sharp angle and obtuse angle line of the needle to be rounded in one embodiment of the present invention.
[0022] Figure 6a is a schematic cross-sectional view of a standard needle tip in the prior art.
[0023] Figure 6b is a schematic cross-sectional view of the needle tip in one embodiment of the present invention, wherein the sharp edge of the needle heel is reversed.
[0024] Figure 7 This is a schematic diagram of the needle tip of the present invention, wherein the heel angle is reversed, and the inner heel side and the needle puncture side are rounded.
[0025] Figure 8 is a schematic cross-sectional view of the prior art needle tip and the polymer-coated guidewire inside the needle.
[0026] Figure 9 This is a schematic cross-sectional view of the needle tip and the polymer-coated guide wire inside the needle according to the present invention. Detailed Implementation
[0027] As shown in Figure 1, the simple needle 1 of the prior art is typically made of a metal thiocyanate tube 10 with an acute-angled bevel slit 11. The bevel angle can vary, as shown in Figure 2, but most conventional needles have an acute angle of 15-30°. Sometimes, the bevel slit is made at two different angles, referred to as a lancet tip.
[0028] Referring now to Figures 3A and 3B, a standard beveled needle tip 12 of the prior art is shown. The needle tip can be divided into region A and region B, region A being the puncture portion 13 of the needle tip, and region B being the heel side 14 of the needle tip.
[0029] The puncture portion 13 occupies approximately 180° of the anterior portion of the needle tip 12, while the heel portion 14 occupies another 180° of the proximal portion of the needle tip 12. The outer circumferential angle of the puncture portion 13 is an acute angle, designed to cut through tissue or plaque, while the inner circumferential angle of the puncture portion 13 is an obtuse angle. The outer circumferential angle of the heel portion 14 is an obtuse angle, while the inner circumferential angle of the heel portion 14 is an acute angle.
[0030] When the guidewire is pushed forward through the device or the hysteresis tube 10 of a device with a beveled needle tip 12 at the distal end, the guidewire does not encounter any sharp needle edges and can safely pass forward without damaging its coating. When the guidewire is pulled back into the device through the needle and encounters a very sharp edge on the heel side of the needle tip during retraction, wear or peeling of the guidewire coating will occur on the rear or heel side 14 of the needle tip.
[0031] In the prior art, if the needle tip 12 contains non-core removal, this non-core removal is based on trimming the inner circumference 16 of the heel 14 using different methods (including using a mechanical milling tool 4 [Fig. 4] or electropolishing or sandblasting on a specific heel area).
[0032] Now for reference Figures 5A-5B In one embodiment of the non-core-removing needle tip 12 of the present invention, the non-core removal of the needle is not based on rounding any inner sharp edge of the needle heel 14, or merely on such rounding, but rather by reversing the direction of the sharp needle edge 17 on the needle heel side. Rounding of the inner diameter edge of the needle heel can be added to the reversal of the direction of the sharp edge on the needle heel side. In other words, the bevel angle of the needle tip is acute, while the reverse edge angle of the reverse edge 17 is obtuse.
[0033] Referring now to Figure 6A, which shows the cross-section of a standard prior art needle, wherein the edge 16 of the heel portion 14 is formed into an inward acute angle.
[0034] Now for reference Figure 6B The diagram shows a cross-sectional view of the needle tip 12 of a tube 10 according to an embodiment of the invention. The sharp edge 17 of the heel portion 14 has an outward reversing direction. Because the sharp edge 17 is radially outward, any guide wire passing through the needle tip 12 will not encounter any acute angles in the forward and backward directions.
[0035] The reversed edge 17 may have an acute angle of 15-45° relative to the outer surface of the tube 10, that is, the reversed edge angle is an obtuse angle of 105-135°; or an obtuse angle of 105-130°; or an obtuse angle of 105-125°; or an obtuse angle of 105-120°; or an obtuse angle of 105-115°; or an obtuse angle of 105-110°; or an obtuse angle of 100-135°; or an obtuse angle of 100-130°; or an obtuse angle of 100-125°; or an obtuse angle of 100-120°; or an obtuse angle of 100-115°; or an obtuse angle of 100-110°.
[0036] Now for reference Figure 5AThe bevel extends from the base of the heel to the tip and has a length BL. The reverse edge 17 has a length REL, which can start from the heel at the base of the bevel at the tip and extend to half the length BL of the bevel; or, the length of the reverse edge 17 can be less than half the length BL of the bevel; or, the length of the reverse edge 17 can be greater than half the length BL of the bevel; or, the length of the reverse edge 17 can be less than half the length BL of the bevel and greater than one-third of the length BL of the bevel.
[0037] The needle of the present invention can be formed with a reverse edge 17 by any suitable manufacturing process. The present invention can also be achieved by modifying existing needles to form the reverse edge 17. For example, to reverse the orientation of the heel edge 16 in the prior art, it is first necessary to remove the sharp edge 16 using a machine tool or by any other means to avoid the straight wall at the heel 14, and then begin reversing the angular direction using a small machine milling or grinding tool or any other metal removal method known in the art. By performing this procedure, the shape of the heel of the needle tip 12 changes, and the length of the needle tip opening increases, such as... Figure 7 As can be seen in the text.
[0038] In another embodiment of the invention, such as Figure 6B As can be seen, any angles or edges on the inner surface of the needle, even those containing obtuse angles on the heel side and the needle puncture side, are rounded to form a rounded edge 19, thereby preventing wear or peeling of the guidewire coating. The radius of the rounded edge 19 can be in the range of 0.1-0.5 mm, but is not limited to this.
[0039] Referring now to Figure 8, the guidewire 3 has a polymer coating 5 and is inserted into a needle of the prior art. The polymer coating 5 may be worn away and peeled off by the sharp edge 16 of the needle. Compared to the prior art, in such cases... Figure 9 In one embodiment of the invention shown, the polymer coating 5 of the guidewire 3 is not worn away by the reverse edge 17 at all.
Claims
1. A puncture device, comprising: A tube (10) having a needle tip (12) is formed, the needle tip (12) being a straight needle tip having a straight needle cavity passing through it, the needle tip including a bevel having a bevel length (BL), the bevel extending from the base of the heel portion (14) of the bevel to the sharp distal radial outer edge of the needle tip (12) at a bevel angle; characterized in that the needle tip (12) has a reverse edge (17), the reverse edge including a planar surface on the heel portion (14) and a rounded edge (19), the rounded edge (19) being at both: the inner heel side of the bevel and the inner needle puncture side of the bevel, wherein the reverse edge angle between the extension of the needle on the outer wall of the heel side of the bevel and the planar surface on the heel portion (14) is an obtuse angle.
2. The puncture device according to claim 1, wherein, The reverse edge angle is an obtuse angle of 100-135°.
3. The puncture device according to claim 1, wherein, The reverse edge angle is an obtuse angle of 100-130°.
4. The puncture device according to claim 1, wherein, The reverse edge angle is an obtuse angle of 100-125°.
5. The puncture device according to claim 1, wherein, The reverse edge angle is an obtuse angle of 100-120°.
6. The puncture device according to claim 1, wherein, The reverse edge angle is an obtuse angle of 100-115°.
7. The puncture device according to claim 1, wherein, The reverse edge angle is an obtuse angle of 100-110°.
8. The puncture device according to claim 1, wherein, The slope has a slope length, and the reverse edge (17) has a length extending from the tip of the needle at the base of the slope to a maximum of half the slope length.
9. The puncture device according to claim 1, wherein, The slope has a slope length, and the reverse edge (17) has a length extending from the tip of the needle at the base of the slope to more than half the slope length.