US-12616438-B2 - Echogenic needle

US12616438B2US 12616438 B2US12616438 B2US 12616438B2US-12616438-B2

Abstract

An echogenic needle may have at least one V-shaped spiral groove formed at its distal portion adjacent to its patient end. The walls of the groove are orthogonal to each other. The groove is titled at a given angle from a neutral position toward the proximal end of the needle so that when the needle is inserted into the patient at an insertion angle under ultrasound imaging, the ultrasound wave emitted from the ultrasound transducer is reflected in a substantially reverse direction back to the transducer by at least one wall of the spiral groove. A pair of crisscrossing grooves may be spirally wound about the distal portion of the needle with each groove being tilted to the given angle to enhance echogeneity. The echogeneity of the needle may also be enhanced by increasing the pitch density of each groove while maintaining the crisscrossing groves at their neutral position.

Inventors

Andrew Crisman
Alysa Lauren Granata

Assignees

SMITHS MEDICAL ASD, INC.

Dates

Publication Date: 20260505
Application Date: 20240628

Claims (14)

1 . A method of making an echogenic needle having a shaft that has a sharp distal tip, a proximal end and an outer circumferential surface, comprising: positioning relative to the needle a tool adapted to cut a groove having walls orthogonal to each other onto the outer circumferential surface of the needle so that walls having the same length would be formed onto the outer circumferential surface of the needle were the needle to lie along a longitudinal axis relative to the tool at a neutral position; repositioning the needle and the tool relative to each other at an angle tilted away from the neutral position toward the proximal end of the needle with the walls remaining orthogonal to each other; and rotatably moving the tool and the shaft of the needle relative to each other to cut a spiral groove having a tilt angle relative to the neutral position onto the outer circumferential surface of at least one section of the needle.
2 . The method of claim 1 , further comprising: preferably positioning the tilt angle to be at 10° away from the neutral position.
3 . The method of claim 1 , further comprising: forming the spiral groove at multiple sections of the needle.
4 . The method of claim 1 , further comprising: forming the spiral groove in one direction along the at least one section of the needle; and rotatably moving the tool and the shaft of the needle relative to each other to form another spiral groove having another tilt angle onto the outer circumferential surface of the needle in another direction along the at least one section such that the spiral groove formed along the one direction and the another spiral groove formed along the another direction crisscross each other.
5 . The method of claim 1 , further comprising: forming the spiral groove having the tilt angle to have a pitch of approximately 0.020 in (0.508 mm).
6 . The method of claim 1 , further comprising: varying the tilt angle from approximately 5° to 25°.
7 . The method of claim 6 , further comprising: forming the spiral groove to have a V-shape.
8 . The method of claim 6 , further comprising: forming the spiral groove to have a non-V shape.
9 . A method of making an echogenic needle having a shaft including a sharp distal tip and a proximal end with an outer circumferential surface having at least one section thereon adapted to reflect ultrasonic waves directed thereat in a substantially reverse direction, comprising: positioning relative to the needle a tool adapted to cut a groove having walls orthogonal to each other onto the outer circumferential surface of the needle so that walls having the same length would be formed onto the outer circumferential surface of the needle if the needle were to lie along a longitudinal axis relative to the tool at a neutral position; repositioning the needle and the tool relative to each other at an angle tilted away from the neutral position toward the proximal end of the needle; and rotatably moving the tool and the shaft of the needle relative to each other to cut a spiral groove having a tilt angle relative to the neutral position onto the outer circumferential surface along the at least one section of the needle with the walls of the groove remaining orthogonal to each other.
10 . The method of claim 9 , further comprising: tilting the angle toward the proximal end of the needle from approximately 5° to 25°.
11 . The method of claim 9 , further comprising: preferably tilting the angle to be at 10°.
12 . The method of claim 9 , further comprising: rotatably moving the tool in another direction relative to the shaft of the needle to form another spiral groove having another angle onto the outer circumferential surface of the needle along another direction different from the direction of the spiral groove such that the spiral groove and the another spiral groove crisscross each other at the at least one section of the needle.
13 . The method of claim 12 , further comprising: forming crisscrossing spiral grooves at multiple sections of the needle.
14 . The method of claim 9 , further comprising: forming the spiral groove to have a pitch of approximately 0.020 in (0.508 mm).

Description

This application is a divisional of, and claims priority from, application Ser. No. 17/679,331 filed on Feb. 24, 2022. The '331 application in turn claims priority from application Ser. No. 15/297,731 filed on Oct. 19, 2016 claiming priority from provisional application No. 62/246,205 filed on Oct. 26, 2015. The disclosures of application Ser. Nos. 17/679,331 and 15/297,731 in their entirety are hereby incorporated by reference. FIELD OF THE INVENTION The present invention relates to echogenic medical devices, and more particularly a needle that may be used for peripheral nerve block (PNB) procedures having echogenic features at its patient end. BACKGROUND OF THE INVENTION There are numerous echogenic needles known. Among them is the Wallace Amniocentesis Needles that are being sold by the assignee of the instant invention. The instant invention aims to improve the echogeneity of the echogenic features of needles use for different surgical procedures including peripheral nerve block (PNB), epidural and others that require ultrasound viewing of the needle during the procedure. SUMMARY OF THE PRESENT INVENTION The echogenic needle of the instant invention has at its distal portion adjacent its patient end at least one section that has a spiral V-shaped groove. The walls of the groove are orthogonal to each other. The groove may be tilted at a given angle from its neutral position toward the proximal end of the needle. The inventive needle is usually inserted into a subject patient at a desirable insertion angle. If the needle is under ultrasound imaging whereby an ultrasound wave is directed to the needle, at least one wall of the tilted groove would reflect the ultrasound wave back to the receiver of the transducer at substantially the reverse direction, i.e., at approximately 180°, to present an improved ultrasound image of the echogenic needle. Also, by decreasing the pitch between the adjacent tips formed by the V-shaped groove, the density of the number of turns for the groove increases. As a result, an enhanced ultrasound wave is reflected back to the receiver of the transducer to provide an improved image of the echogenic needle, even were the groove not tilted at the aforenoted given angle. In one embodiment, by forming the echogenic groove in a spiral fashion, while maintaining the preferred tilt angle to the groove, the echogenic needle of the instant invention may be made simply. Moreover, that the walls of the groove are orthogonal to each other means that the only angle that needs to be adjusted with regard to the production of the echogenic needle is the tilt angle, which may simply be done by adjusting either the angle of the needle shaft that is being cut, or the angle of the cutting wheel or tool used to cut the groove as the needle shaft is rotatably moved relative to the cutting wheel, which may also be rotating. In an other embodiment, the pitch (of the sidewalls) of the groove is further decreased so as to increase the pitch density for the spiral groove to a range that leads to an improved reflection of the ultrasound image. For the other embodiment, there may not be a need to tilt the groove. Instead of one spiral groove, the echogenic section of the needle may be made with two crisscrossing spiral grooves, i.e., one clockwise and one counter-clockwise relative to the sharp tip of the needle. Each of the V-shaped grooves has walls that are orthogonal to each other. Furthermore, the grooves each may be tilted at a predetermined angle relative to the proximal end of the needle to effect a substantially 180° reflection of the ultrasound wave from the transducer back to the transducer, when the needle is positioned at an insertion angle that facilitates the insertion of the needle into the subject patient. Instead of one echogenic section, the distal portion of the needle shaft may have a plurality of echogenic sections. For the exemplar embodiments, the needle shaft may have two echogenic sections separated by a non-groove section, so that there are two sections of crisscrossing spiral grooves each adapted to be tilted at a predetermine angle to reflect the ultrasound wave emitted from a transducer back to the transducer. In the other embodiment, the crisscrossing spiral sections are not tilted. Accordingly, the walls of each of the spiral grooves would have the same length while substantially orthogonal to each other. The instant invention is therefore directed to a needle for viewing under ultrasound imaging that comprises a shaft extending along a longitudinal axis having a proximal end and a distal end including a sharp tip, one and other grooves spirally formed clockwise and counterclockwise, respectively, from at least adjacent the sharp tip along a distal portion of the shaft so that the one and other grooves crisscross each other a predetermined distance along the distal portion, the one and other grooves each being at a neutral position relative to the longitudinal axis of the sha