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US-12622723-B2 - Non-coring needle with reversed sharp edge

US12622723B2US 12622723 B2US12622723 B2US 12622723B2US-12622723-B2

Abstract

A piercing device includes a tube ( 10 ) formed with a needle tip ( 12 ). The needle tip ( 12 ) includes a bevel having a bevel length (BL) that extends at a bevel angle from a base of a heel ( 14 ) to a sharp distal, radially outer edge of the needle tip ( 12 ). A reversed edge ( 17 ) is formed as a reversed edge angle on the heel ( 14 ) of the bevel. The bevel angle is an acute angle, and the reversed edge angle is an obtuse angle.

Inventors

  • Yossi Pesis
  • Dan Rottenberg

Assignees

  • UPSTREAM PERIPHERAL TECHNOLOGIES LTD.

Dates

Publication Date
20260512
Application Date
20211108

Claims (9)

  1. 1 . A piercing device comprising: a tube ( 10 ) formed with a needle tip ( 12 ), said needle tip ( 12 ) comprising a bevel having a bevel length (BL) that extends at a bevel angle from a base of a heel ( 14 ) of the bevel to a sharp distal, radially outer edge of said needle tip ( 12 ); and a reversed edge ( 17 ) including a planar surface on the heel ( 14 ) of the bevel and rounded edges ( 19 ) at both an internal heel side of the bevel and an internal needle piercing side of the bevel, wherein a reversed edge angle between an outer surface of the tube at the heel side of the bevel and the planar surface is an obtuse angle.
  2. 2 . The piercing device according to claim 1 , wherein said reversed edge angle is an obtuse angle of 100-135°.
  3. 3 . The piercing device according to claim 1 , wherein said reversed edge angle is an obtuse angle of 100-130°.
  4. 4 . The piercing device according to claim 1 , wherein said reversed edge angle is an obtuse angle of 100-125°.
  5. 5 . The piercing device according to claim 1 , wherein said reversed edge angle is an obtuse angle of 100-120°.
  6. 6 . The piercing device according to claim 1 , wherein said reversed edge angle is an obtuse angle of 100-115°.
  7. 7 . The piercing device according to claim 1 , wherein said reversed edge angle is an obtuse angle of 100-110°.
  8. 8 . The piercing device according to claim 1 , wherein said bevel has a bevel length and said reversed edge ( 17 ) has a length up to half the bevel length.
  9. 9 . The piercing device according to claim 1 , wherein said bevel has a bevel length and said reversed edge ( 17 ) has a length more than half the bevel length.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is the U.S. national phase of PCT Appln. No. PCT/IB2021/060322 filed Nov. 8, 2021, which claims the benefit of U.S. provisional application Ser. No. 63/111,153 filed Nov. 9, 2020, the disclosures of which are hereby incorporated in their entirety by reference herein. FIELD OF THE INVENTION The present invention relates generally to novel needle sharp edges designed to prevent coated guidewires from getting damaged, due to coating abrasion or peeling. BACKGROUND OF THE INVENTION Chronic Total Occlusion (CTO) is an arterial vessel blockage (typically of plaque) that obstructs blood flow. CTO can occur both in coronary and peripheral arteries, and generally results from the same underlying cause—atherosclerosis. One of the main difficulties in crossing a total occlusion is that the clinician does not know exactly how hard the plaque is until steering a guidewire to the occlusion. If the occlusion is relatively new, the plaque is likely to be soft enough and the guidewire may penetrate the plaque. However, after several weeks or months, the occlusion becomes fibrotic and calcified and the plaque becomes much harder, rendering guidewire crossing of the occlusion difficult if not impossible. Failure to cross the obstruction is the primary failure mode for CTO recanalization. If the guidewire cannot pass the occlusion, support catheters and crossing catheters are used to support the guidewire to pass the occlusion. Such crossing catheters may have a blunt tip. If CTO intra-luminal crossing is not possible, techniques have been developed for entering the subintimal space and reentering the true lumen after the occlusion. This so-called subintimal recanalization can be a useful procedure and is widely used. One of the advantages of subintimal recanalization is that a dissection of the subintimal space is more likely to produce a smooth lumen and improved blood flow than a lumen produced by plowing through calcified plaque. However, technical failure occurs in about 25% of patients undergoing percutaneous subintimal recanalization, mainly due to the inability to reenter the distal true lumen. If during percutaneous subintimal recanalization, the true lumen cannot be reentered with guidewire manipulation, a true lumen reentry device must be used. Currently there are several specially designed reentry devices in the market. Most of them used straight or curved needle to reenter the guidewire into the true lumen after the occlusion. Most guidewires available today are polymer coated guidewires, sometimes hydrophilic coated guidewires and many with both polymer and hydrophilic coatings. Such a coating provides significantly less friction and better pushability. However, using such a coated guidewire with a sharp needle has the risk of damaging the guidewire, when withdrawn backwards, due to abrasion and/or peeling of the coating by the sharp needle edges. This risk is even more severe and dangerous when the guidewire coating abrasion or peeling occurs inside the patient blood vessels. Some non-coring characteristics can be added to needle tips and are known in the art. Techniques such as gentle mechanical milling of the needle heel, sand-blasting or electro-polish can be used to slightly round the sharp, yet very thin edges of the needle heel. The rounding radius is very small due to the thin wall thickness of the needle hypo-tube. However, in the prior art, only the interior sharp edges of the needle are rounded, and the outer edges remain sharp to penetrate the tissue or plaque. Therefore, in the prior art, masking the outer edges to avoid rounding them is required. SUMMARY OF THE INVENTION The present invention seeks to provide novel needle non-coring devices and process thereof. The non-coring needle tip of the present invention allows safe pass of polymer coated guidewires and/or hydrophilic coated guidewires through the sharp needle tip, eliminating the risk of coating abrasion or peeling by the needle sharp edges. The present invention of non-coring needle tip can be applied on any type of needle tip and any type of catheter, or any other device that includes a sharp needle. The non-coring needle tip of the present invention can be a straight or curved needle tip. A simple prior art needle is usually made from a metal hypo-tube with bevel cut at an acute angle, usually at about 20°. Sometimes the bevel cut is made with two different angles, called a lancet needle tip. In the prior art, when pushing a guidewire forward through a device with bevel needle tip at the distal end, the guidewire does not see any sharp needle edges and can pass safely without damage to its coating. Abrasion or peeling of guidewire coating occurs at the back side or the heel side of the needle tip, when the guidewire is pulled back into the device through the needle, meeting very sharp edges of the heel side of the needle tip. The non-coring needle tip of the invention is based on re