COPPER-NIOBIUM ALLOY FOR MEDICAL BIOPSY PUNCTURE NEEDLE

Abstract

The present disclosure discloses a copper-niobium alloy for a medical biopsy puncture needle. A needle core and/or needle tube of the puncture needle are/is made of the copper-niobium alloy. The copper-chromium alloy includes the following components by mass: 5≤Nb≤15 and the balance of Cu. According to the present disclosure, a copper alloy with designed components is obtained by combining a diamagnetic material Cu with paramagnetic Nb, and compared with existing medical stainless steel and titanium alloy, the copper alloy has greatly reduced magnetic susceptibility, and specifically, the artifact area and volume are also significantly reduced. In addition, the blank of use of the copper alloy in medical biopsy paracentesis is filled.

Claims

1. A copper-niobium alloy for a medical biopsy puncture needle, wherein a needle core and/or needle tube of the puncture needle are/is made of the copper-niobium alloy, and the copper-niobium alloy comprises the following components by mass: 5≤Nb≤15 and the balance of Cu.

2. The copper-niobium alloy for a medical biopsy puncture needle according to claim 1, wherein the needle core and the needle tube are processed as follows: (1) using granular materials with a purity greater than or equal to 99.99% for smelting to obtain a copper-niobium alloy ingot with a diameter of 60-100 mm; (2) cutting off a riser and finishing a surface of the ingot; (3) placing the ingot in a high temperature furnace for heat treatment at 900-1,000° C. for 1-2 h, and forging the ingot to a round bar with a diameter of 10-30 mm; (4) conducting solution quenching treatment on the round bar at 900-1,000° C. for 2-4 h; and (5) conducting needle core forming: drawing the round bar processed in step (4) in multiple passes to the needle core of a design specification, and conducting annealing at 550-650° C. for 1-2 h; and conducting needle tube forming: drilling the round bar processed in step (4), and conducting continuous operations of tube reducing, continuous rolling, and heat treatment to finally obtain the needle tube of a design specification.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1: a structure of a medical biopsy puncture needle;

[0020] FIG. 2: a flow chart of needle tube processing;

[0021] FIG. 3: a scanning electron image (SEM) of Cu10Nb with a diameter of 2.65 mm after large deformation; and

[0022] FIG. 4: two-dimensional (2D) artifact maps of MRI in directions parallel to and perpendicular to a magnetic field. a and d are Cu10Nb, b and e are TC4, and c and f are 304 stainless steel.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0023] The present disclosure is described in more detail below with examples that optimize and analyze the materials of the present disclosure.

[0024] FIG. 1 shows a basic structure of a conventional medical biopsy puncture needle, mainly including a needle core 1 and a needle tube 2. The needle core 1 is inserted into the needle tube 2 and can move up and down. In the puncture process of orthopedic operation, the needle tube are mainly used for positioning, and cooperates with the needle core to penetrate the bone marrow.

[0025] Taking the Cu10Nb alloy as an example below, specific processing of the medical biopsy puncture needle of the present disclosure is described in detail.

[0026] (1) Small particle raw materials with a purity greater than or equal to 99.99% (particle size of about 10 mm) were used for smelting to obtain Cu10Nb with a mass of 20 kg and a diameter of 80 mm.

[0027] (2) A riser was cut off and a surface of the ingot was finished.

[0028] (3) The ingot was placed in a chamber electric furnace for heat treatment at 960° C. for one hour, and the ingot was forged to a round bar with a diameter of 20 mm.

[0029] (4) Solution quenching treatment was conducted on the round bar at 960° C. for two hours.

[0030] (5) Needle core forming was conducted:

[0031] The round bar obtained in step (4) was drawn in multiple passes to needle cores with diameters of 3.61 mm, 3.5 mm, 2.65 mm, 2.2 mm, and 0.9 mm, and intermediate annealing was conducted at 600° C. for 1 h.

[0032] Needle tube forming was conducted:

[0033] The round bar obtained in step (4) was drilled to obtain a tube with an aperture of 13 mm and an outer diameter of 20 mm, and continuous operations of tube reducing, continuous rolling, and heat treatment were conducted (see FIG. 2). The finally obtained size of the needle tube is shown in Table 1:

TABLE-US-00001 TABLE 1 Needle tube size Nominal outer Inner Wall Length diameter (mm) diameter (mm) thickness (mm) (mm)  1.4 ± 0.01 0.95 0.225 100 3.33 ± 0.01 2.33 0.5 100  3.5 ± 0.01 2.8 0.35 100 4.17 ± 0.01 3.61 0.28 100

[0034] Performance Test

[0035] I. Ion Precipitation Detection

[0036] In the present disclosure, the Cu10Nb alloy was compared with electrolytic Cu to detect the precipitation of Cu ions in the simulated body fluid, but the precipitation of Nb was not detected, so it is not listed in the table. The test results are shown in Table 2.

TABLE-US-00002 TABLE 2 Precipitation of Cu ions in simulated human body fluids (mg/L) Cu-ion dissolution Material (7 days) (15 days) (30 days) Cu 4.81 8.58 10.09 Cu10Nb 3.49 5.90  7.83

[0037] II. Corrosion Resistance Testing

[0038] The present disclosure tested anodic polarization curves of Cu, Cu10Nb and a comparative material SUS304 in simulated body fluid. The results are shown in Table 3.

TABLE-US-00003 TABLE 3 Corrosion potential and corrosion current density of three materials in simulated human body fluids Ecorr (V) Icorr (10.sup.−6A/cm.sup.−2) Cu −0.24 7.544 Cu10Nb −0.29 4.608 SUS304 −0.26 0.176

[0039] III. Magnetic Susceptibility Test

[0040] Hysteresis curves of the material Cu10Nb prepared by the present disclosure and the comparative materials pure Ti, Ti6Al4V (TC4), and SUS304 were measured. The specific parameters were as follows: a magnetic field range was ±1.5T, a scanning speed was 1-200 Gauss/s, a magnetic field resolution was 0.02 mT, a temperature control range was 1.9-400 K, a temperature scanning speed was 0.01-12 K/min, and a temperature stability was ±0.2% when it was less than 10 K, and ±0.02% when it was greater than 10 K. Finally, the χ value of the mass magnetic susceptibility calculated from M=χ/H is shown in Table 4.

TABLE-US-00004 TABLE 4 Magnetic susceptibility of processed and comparative materials Alloy Cu10Nb Ti TC4 SUS304 χ/10.sup.−6 1.26 11.29 21.31 2311.64

[0041] IV. MRI Test

[0042] Firstly, agarose powder with a mass fraction of 2% was added to deionized water and boiled until dissolved. 10 mM Ni(NO.sub.3).sub.2 and a 2% agarose solution were fully stirred for mixing to obtain agarose gel. Finally, the mixed gel was poured into a cylindrical open mold with a sample and subjected to still standing for thirty minutes. The agarose gel embedded with the sample was removed and tested under MRI. For the detection of magnetic resonance, fast spin-echo (FSE) and gradient-echo (GRE) pulse sequences were selected for image acquisition. As follows: a long axis of the metal was set parallel and perpendicular to a static magnetic field (B0), and positioning guides were used to achieve the same placement for each MRI test. The magnetic susceptibility of a nickel-doped agarose gel phantom was measured. MR images were acquired using a 1.5 T MR scanner (Signa-HDxt, GE Healthcare Waukesha, USA). T1-weighted sequence spin echo (SE) was used, a frequency matrix was 512 voxels, a phase matrix was 512 voxels, a field of view (FOV) was 150*150 mm, 3 mm multi-layer acquisition without inter-patch gap was conducted, and a total of 3 patches were obtained. The frequency and patch directions were parallel to B0 (head-to-foot, HF). The sequence-specific parameters were as follows: for the SE sequence, a bandwidth (BW) was 16.5 kHz, an echo sequence length was 2, a repetition time (TR) was 400 ms, an echo time (TE) was 11 ms, full Fourier acquisition was conducted, and a number of excitation (NEX) was 1.

[0043] The test results are shown in FIG. 4. Obviously, the artifact areas of TC4 and SUS304 are larger than that of the Cu10Nb alloy in the directions parallel and perpendicular to the static magnetic field. In addition, an irregular shape is shown.

[0044] The above examples are intended to illustrate only the technical conception and characteristics of the present disclosure, and are intended to enable a person familiar with the technology to understand content of the present disclosure and apply the content accordingly, and shall not limit the scope of protection of the present disclosure thereby. Any equivalent change or modification in accordance with the spiritual essence of the present disclosure shall fall within the scope of protection of the present disclosure.