Medical needle and method of maintaining sharpness of needle

Patent metadata

Field	Value
Publication number	US-10668189-B2
Application number	US-201815874269-A
Country	US
Kind code	B2
Filing date	Jan 18, 2018
Priority date	Mar 31, 2017
Publication date	Jun 2, 2020
Grant date	Jun 2, 2020

Abstract

Disclosed is a medical needle used for performing a piercing or insertion operation on an object repetitively, the medical needle comprising a needle body and a metallic glass material layer formed on a surface of the needle body, the metallic glass material layer comprising an alloy consisting of aluminum, zirconium, copper and tantalum. With the presence of the metallic glass material layer covering the needle body, the medical needle may maintain its sharpness after having performed multiple piercing or insertion operations to enhance durability, minimize the increase of maximum piercing or insertion force resulted from piercing or insertion operations, and decrease injury to the object caused by piercing or insertion operations.

First claim

What is claimed is:

1. A medical needle used for performing a piercing or insertion operation on an object repetitively, the medical needle comprising:
a needle body; and
a metallic glass material layer formed on a surface of the needle body, the metallic glass material layer comprising an alloy consisting of aluminum, zirconium, copper and tantalum;
wherein the presence of the metallic glass material layer covering the needle body maintains a sharpness of the medical needle such that an increase percentage of a maximum piercing or insertion force of a nth piercing or insertion operation relative to a first piercing or insertion operation, represented by ((X n −X 1 )/X 1 )*100%, is not greater than 18.9%, given that: N represents the number of piercing or insertion operations performed by the medical needle on the object and ranges from 5 to 80 inclusive; n is a natural number from 5 to N; X 1 represents the maximum piercing or insertion force required for the first piercing or insertion operation; and X n represents the maximum piercing or insertion force required for the nth piercing or insertion operation;
wherein the metallic glass material layer is formed by a magnetron sputtering process in which the needle body and a target are placed in a vacuum environment with a work pressure of 0.5 to 4 mTorr, a distance between the needle body and the target is set at 8 to 12 cm, a radio frequency energy is provided between the needle body and the target, and the power density of the target is 3.65 to 10.96 W/cm 2 ; and the metallic glass material layer thus formed has a surface roughness of between 0.44 and 0.54 nm.

2. The medical needle of claim 1 , wherein the needle body is a curved 6/0 cutting needle and the object is a rubber, and wherein when N is 40, the value of ((X 40 −X 1 )/X 1 )*100% of the medical needle is not greater than 0.337-fold of that of a needle body without the metallic glass material layer.

3. The medical needle of claim 1 , wherein the needle body is a curved 7/0 taper needle and the object is a rubber, and wherein when N is 40, the value of ((X 40 −X 1 )/X 1 )*100% of the medical needle is not greater than 0.143-fold of that of a needle body without the metallic glass material layer.

4. The medical needle of claim 1 , wherein the needle body is a curved 6/0 cutting needle and the object is a rubber, and wherein when N is 40, the value of ((X 40 −X 1 )/X 1 )*100% is not greater than 9.9%.

5. The medical needle of claim 1 , wherein the needle body is a curved 7/0 taper needle and the object is a rubber, and wherein when N is 40, the value of ((X 40 −X 1 )/X 1 )*100% is not greater than 6.1%.

6. The medical needle of claim 1 , wherein the needle body is a curved 6/0 cutting needle and the object is an artificial blood vessel made of polymeric material, and wherein when N is 40, the value of ((X 40 −X 1 )/X 1 )*100% is between −1.5% and 5%.

7. The medical needle of claim 1 , wherein the needle body is selected from a cutting needle, a taper needle, a straight needle and a curved needle.

8. The medical needle of claim 1 , wherein the metallic glass material layer has an amorphous structure which renders a broad diffraction peak only between 30° and 40° as measured by X-ray diffraction.

9. The medical needle of claim 1 , wherein the metallic glass material layer comprises Zr 53 Cu 33 Al 9 Ta 5 .

10. The medical needle of claim 1 , wherein the metallic glass material layer has a hardness of 700 to 2000 HV.

11. A medical needle used for performing a piercing or insertion operation on an object repetitively, the medical needle comprising:
a needle body; and
a metallic glass material layer formed on a surface of the needle body, the metallic glass material layer comprising an alloy consisting of aluminum, zirconium, copper and tantalum;
wherein, given that the medical needle is subject to N times of piercing or insertion operation, wherein N ranges from 5 to 80 inclusive, and given that a maximum piercing or insertion force of a nth piercing or insertion operation is X n , wherein n is a natural number from 1 to N, a dataset of every n and X n in the N times of piercing or insertion operation is characterized by having a slope of simple linear regression estimated using the ordinary least squares method of not greater than 0.00654 as calculated according to the formula below:

a
′

=

∑

n
=
1

N

⁢

(

X
n

-

X
N

_

)

⁢

⁢

(

n
-

N
_

)

⁢

/

⁢

∑

n
=
1

N

⁢

(

X
n

-

X
N

_

)

2

wherein a′ represents the slope, X N represents an average maximum piercing or insertion force during the N times of piercing or insertion operation, and N represents an average of 1 to N,
wherein the metallic glass material layer is formed by a magnetron sputtering process in which the needle body and a target are placed in a vacuum environment with a work pressure of 0.5 to 4 mTorr, a distance between the needle body and the target is set at 8 to 12 cm, a radio frequency energy is provided between the needle body and the target, and the power density of the target is 3.65 to 10.96 W/cm 2 ; and the metallic glass material layer thus formed has a surface roughness of between 0.44 and 0.54 nm.

12. The medical needle of claim 11 , wherein the slope is a negative value.

13. The medical needle of claim 11 , wherein the needle body is a curved 6/0 cutting needle and the object is a rubber, and wherein when N is 40, the slope is between 0.00131 and 0.00654.

14. The medical needle of claim 11 , w

Assignees

• Univ Nat Taiwan Science & Technology

Inventors

• Chu Jinn P
• Jiang Guei-Huang
• Chang Shih-Hsin
• Chen Ming-Jen

Classifications

• A61B2017/00526

  Methods of manufacturing · CPC title

• A61B17/06066 Primary

  Needles, e.g. needle tip configurations · CPC title

• A61L31/049

  Rubbers · CPC title

• A61B2017/00849

  with respect to tissue, e.g. hollow organs · CPC title

• A61L31/088

  Other specific inorganic materials not covered by A61L31/084 or A61L31/086 · CPC title