WO2014114154A1

WO2014114154A1 - Self-deformation metal marker

Info

Publication number: WO2014114154A1
Application number: PCT/CN2013/090074
Authority: WO
Inventors: 刘苗生; 王崇宇; 梁缘; 刘泰华
Original assignee: Liu Miaosheng
Priority date: 2013-01-28
Filing date: 2013-12-20
Publication date: 2014-07-31
Also published as: CN103961802A

Abstract

The present invention relates to a self-deformation metal marker for marking an object to be marked in a body during radiographic inspection or treatment, which is made of a memory alloy with a transformation temperature of 20 - 37°C. Under the condition of temperature lower than the transformation temperature, the marker is shaped to be a straight line segment the length of which is from 3 mm to 100 mm and the cross section with the diameter of 0.1-1.6 mm is a circle or a polygon, and under the condition of temperature higher than the transformation temperature, the shape of the marker is changed into a straight line segment having a marking ball with the diameter of 1 mm-5 mm in the middle thereof and/or having one or two folded or helical ends. The metal marker can be implanted in a position in the body to be marked using a fine puncture needle, so that the puncture damage caused by a larger puncture needle is avoided. The shape which has a relatively large marking ball and of which both ends are curved in a folded or helical manner is presented in the body, so that x-ray fluoroscopy or development under CT is easily performed, and moving and shifting will not occur in the body, thereby the marker can accurately locate a target, and particularly is suitable for being placed in a target area of a tumor to be treated by radiotherapy.

Description

Self-deforming metal marking technology field

The present invention relates to a self-deforming metal mark which is small in volume and which can be marked by an 18G piercing needle having a diameter of less than 1.2 mm, or a finer fine needle inserted into the body target. When the metal marker enters the body, the local diameter can be enlarged or folded to facilitate visualization under fluoroscopy, and the two bends are not easily swept in the body. Background technique

Nowadays, the in vivo markers for radiotherapy are bulky, and it is easy to develop the mark with a diameter of more than 1.5 mm. However, such a large diameter mark requires a 16G or more thick needle that has a diameter of 2 mm or more to be implanted into the body. Large, often only able to implant superficial parts, unable to reflect the true position and movement of deep targets, and the implanted markers are often easy to walk. In order to overcome the limitations of existing markers that are invasive, unclear, and unable to dynamically display targets in real time, we have designed a self-deforming metal marker. The metal marking structure is simple, small in size, and difficult to walk. The target can be marked by a fine needle insertion into the body. Summary of the invention

According to the present invention, there is provided a self-deforming metal marker for labeling in vivo (in particular, a tumor target region marker during radiotherapy) during radiographic examination or treatment, from an abnormal temperature of 18 to 37 ° C, preferably 20 to 35 ° C, More preferably, it is made of a memory alloy of 20-30 ° C. Under conditions lower than the metamorphic temperature (for example, below 20 ° C), it is 3 mm to 100 mm in length, preferably 10 to 40 mm, more preferably 20 to 30 mm, more Preferably, the shape of a straight line segment having a cross section of about 20 mm, a diameter of 1.6 to 0.1 mm, preferably a diameter of 0.3 to 0.8 mm, more preferably 0.5 to 0.6 mm, more preferably about 0.6 mm, of a circular or polygonal cross section, above the metamorphic temperature Under conditions (for example, into a human body with a body temperature above 37 °C), change to a mark with a diameter of 1 mm to 5 mm in the middle of a straight line segment, for example, 1 mm to 3 mm and/or a shape with one or two folded or spiral ends . When the cross section of the straight line segment is a polygon, the diameter is the equivalent diameter of the polygon.

The above self-deformable metal mark having a folded or spiral end at a temperature higher than the metamorphic temperature can pass A cross section of from 3 mm to 100 mm, preferably from 10 to 40 mm, more preferably from 20 to 30 mm, more preferably from about 20 mm, a diameter of from 0.1 to 1.6 mm, preferably from 0.3 to 0.8 mm, more preferably from 0.5 to 0.6 mm, more preferably from about 0.6 mm. A circular or polygonal memory alloy with an abnormal temperature of 18 to 37 ° C is processed into a shape having a folded or spiral end at a temperature higher than the metamorphic temperature, and then straightened below the metamorphic temperature. preparation. The above self-deformed metal mark having a mark ball at a temperature higher than the metamorphic temperature can be processed into a total length of 3 mm to 100 mm, preferably 10 to 40 mm, more preferably by a memory alloy having an abnormal temperature of 18 to 37 ° C above the metamorphic temperature. 20 to 30 mm, more preferably about 20 mm, a mark having a diameter of 1 mm to 5 mm (for example, 1 mm to 3 mm) in the middle, and a straight line segment at both ends of the mark ball has a diameter of 0.1 1.6 mm, preferably a diameter of 0.3 to 0.8 mm, more preferably 0.5~ 0.6 mm, more preferably about 0.6 mm, and then straightened below the metamorphic temperature, and stamped the center of the marker ball into a straight line segment shape having substantially the same diameter as the straight line segments on either side of the marker ball. obtain. A self-deforming metal mark having both a folded or spiral end and a marking ball above the metamorphic temperature can be obtained by a combination of the above two methods.

Preferably, the self-deformed metal mark is changed to a diameter of 1 mm to 5 mm (for example, 1 mm to 3 mm, 3 mm to 5 mm, 3 mm) under conditions higher than the abnormal temperature (for example, into a human body having a body temperature of 37 ° C or higher). , 5 mm, etc., the marking ball and having the shape of two folded or spiral ends, and the diameter of the marking ball is larger than the diameter of the straight line segment. The self-deforming metal mark can be processed into a total length of 3 mm to 100 mm, preferably 10 to 40 mm, more preferably 20 to 30 mm, more preferably about 20 mm, by a memory alloy having an abnormal temperature of 18 to 37 ° C above the metamorphic temperature. The mark ball having a diameter of 1 mm to 5 mm (for example, 1 mm to 3 mm) and a straight line segment at both ends of the mark ball have a diameter of 0.1 1.6 mm, preferably a diameter of 0.3 to 0.8 mm, more preferably 0.5 to 0.6 mm, still more preferably about 0.6 mm and have The shape of one or two folded or spiral ends, then straightened below the metamorphic temperature, and stamped the center of the marker ball into a line having approximately the same diameter as the straight line segments on either side of the marker ball Line shape to get. The total length described herein is the length after the folded or helical ends are straightened. The marker ball can also be formed by thin deformed wire welding, folding, winding, and stamping or grinding by rough deformed wire. The marker ball can be located anywhere in the middle of the straight line segment, for example at a position of 40 to 60% of the total length of the straight line segment, preferably at about 50% of the total length of the straight line segment.

The memory alloy is not particularly limited as long as it has an abnormal temperature of 18 to 37 ° C, preferably a nickel-titanium memory alloy, for example, a memory metal stent produced by Beijing Yanken Yijin New Material Co., Ltd., nickel. A nickel-titanium alloy wire material having a ratio of titanium atoms of 1:1 and a phase change temperature of 20 °C. The processed self-deforming metal mark can be stored along with its piercing needle to preserve the metamorphic temperature below, for example

In a container below 20 ° C, if necessary, it is implanted into a target area (for example, a tumor target area) by a penetrating (medical intervention method), and when the target area is heated by body temperature, the temperature exceeds an abnormal temperature, for example, 20 ° C or more. Automatically becomes a curved line segment with a folded or spiral end or with a folded or spiral end with a marking ball. The center of the marker ball is more than 1.5 mm in diameter and is therefore easy to develop. The folded or spiral end makes it difficult for the self-deformed metal marker to swim.

The invention also provides the use of the above self-deforming metal marking for use as an in vivo marker during radiation examination or treatment.

The invention has the beneficial effects that the thin-shaped deformed metal mark preserved in a low temperature state can be implanted into the part of the body to be marked with a thin needle, thereby avoiding the wearing of the needle by the large piercing needle. Damage; the self-deforming metal marking knot exhibits a folded or spirally curved shape with a larger marked ball in the body, and the shape of the folded or spirally curved end of the marked ball causes the deformed metal The mark is easy to develop under fluoroscopy or CT without moving displacement in the body and accurately positioning the target. It is especially suitable for placement in tumor target areas where radiotherapy is intended.

DRAWINGS

The invention and its main manufacturing process are further described below with reference to the accompanying drawings and embodiments:

Fig. 1 is a perspective view showing the shape of a straight line segment when the self-deformed metal mark is lower than the metamorphic temperature in vitro. Fig. 2 is a view in which the self-deformed metal mark is close to the body temperature in the body, i.e., higher than the metamorphic temperature, and partially has at least one mark ball 3 having a diameter larger than 1 mm, and the shape of the folded shape 3 at both ends is folded.

Figure 3 illustrates several ways in which a deformed metal mark forms a marker ball at a temperature above the metamorphic temperature.

In the figure: 1. The straight line segment of the self-deformed metal mark below the metamorphic temperature; 2. The cross section of the straight line segment of the self-deformed metal mark (circular); 3 is the mark on the self-deformed metal mark after the metamorphic temperature Ball; 4, bent at both ends of the self-deformed metal mark after higher than the metamorphic temperature; 5. Marking ball formed by folding; 6. Marking ball formed by winding. 7. Marking balls formed by stamping or grinding. detailed description

The invention will be specifically described below with reference to the accompanying drawings.

As shown in FIG. 1 , it shows a three-dimensional schematic diagram of a straight line segment shape when the self-deformed metal mark is lower than the metamorphic temperature in vitro, and is a linear line segment 1 of a memory alloy wire having a diameter of about 0.6 mm, and has a circular cross section. 2, such a small cylindrical segment can be implanted into the target target area in the body through a 19G or finer through-needle with an outer diameter of 1 mm.

As shown in Fig. 2, a deformed metal marker ball with a deformed diameter conforming to a deformed temperature is selected, and a section of a memory alloy wire segment having a diameter of 0.6 mm is welded at both ends thereof, and the segment is bent into a required state. The shape of the self-deformed metal can be formed at a shape higher than the metamorphic temperature.

As shown in Fig. 3, the marking ball can be formed in several ways, 5 means that the marking ball can be formed by folding the deformed wire; 6 means that the marking ball can be formed by the method of winding the deformed wire; The larger diameter of the deformed wire is stamped at both ends, and the middle section retains the coarser diameter to make the marked ball.

Application example

Use a nickel-titanium alloy wire material (memory alloy) with a phase change temperature of 20 °C, which is a 1:1 ratio of nickel and titanium atoms produced by Beijing Yanken Yijin New Material Co., Ltd., at a temperature higher than the metamorphic temperature. The above-mentioned nickel-titanium alloy wire material is processed into a sphere having a diameter of about 3 mm, and then linear straight sections of the above-mentioned memory alloy each having a length of about 10 mm and having a diameter of about 0.6 mm are welded on both sides of the sphere, and the both ends of the line segment are folded. Bending, as shown in Figure 2. It is then straightened below the metamorphic temperature and the center marker ball is stamped into a linear segment shape having substantially the same diameter (i.e., about 0.6 mm) as the straight line segments on either side of the marker ball. It is then sterilized to obtain a self-deforming metal mark, which is placed in a piercing needle as a linear segment having a diameter of about 0.6 mm under conditions below the metamorphic temperature. In the case of radiation therapy, the self-deformed metal marker is delivered to the tumor target tissue via a catheter by medical intervention. According to CT imaging, the linear segment-shaped self-deformed metal mark has a shape as shown in FIG. 2 in the tumor tissue (ie, has a marker ball in the middle, and both ends are folded and bent), can be well developed, and is fixed in position. , does not move, so that the position of the tumor can be well positioned.

Claims

Claim

1. A self-deforming metal marker for marking a marker in vivo during radiation examination or treatment, made of a memory alloy having an abnormal temperature of 18 to 37 ° C, preferably 20 to 35 ° C, at a temperature lower than the metamorphic temperature It is a cross section of 3 mm to 100 mm in length, preferably 10 to 40 mm, more preferably 20 to 30 mm, more preferably about 20 mm, 0.1 0.1 mm in diameter, preferably 0.3 to 0.8 mm, more preferably 0.5 to 0.6 mm, still more preferably about 0.6 mm. a shape of a straight line segment having a circular or polygonal shape, which is changed to a mark ball having a diameter of 1 mm to 5 mm in the middle of a straight line segment and/or having one or two folded or spiral ends at a temperature higher than the abnormal temperature. shape.

2. The self-deforming metal mark according to claim 1, wherein the self-deformed metal mark is changed to a mark ball having a diameter of 1 mm to 5 mm in the middle and having two folds or more under conditions higher than the abnormal temperature. a shape of the spiral end, and the diameter of the marking ball is larger than the diameter of the straight line segment.

The self-deformed metal mark according to claim 1 or 2, wherein the memory alloy is a nickel-titanium memory alloy having an abnormal temperature of 20 to 37 °C.

The self-deformed metal mark according to claim 1 or 2, wherein the memory alloy is a nickel-titanium alloy wire material having a ratio of nickel to titanium of 1:1 and a phase change temperature of 20 °C.

5. The self-deforming metal marker of claim 2, wherein the marker ball is formed by fine memory alloy wire soldering, folding, winding, or rough deformed wire stamping or grinding.

6. Use of a self-deforming metal marker according to any of claims 1-5 as an in vivo marker for radiation examination or treatment.