WO2020174791A1

WO2020174791A1 - Medical device

Info

Publication number: WO2020174791A1
Application number: PCT/JP2019/046312
Authority: WO
Inventors: 島田　順一
Original assignee: Ｙａｎｃｈｅｒｓ株式会社
Priority date: 2019-02-26
Filing date: 2019-11-27
Publication date: 2020-09-03
Also published as: JPWO2020174791A1; JP6975504B2

Abstract

The present invention discloses a novel medical device in which image artifacts are not produced in magnetic resonance imaging (MRI). This medical device comprises a metal or includes a component comprising a metal, the metal being a stainless steel that contains a high amount of manganese. The manganese content in the stainless steel that contains a high amount of manganese is preferably 13-22 mass% inclusive. Using this medical device makes it possible for the medical device to clearly conduct visualization in MRI inside a living body.

Description

\¥02020/174791 1 卩(: 17 2019/046312

Specification

Title of invention: Medical device

Technical field

The present invention relates to a medical device, and more particularly to a medical device used near a magnetic resonance imaging (hereinafter sometimes referred to as “1^1”) apparatus.

Background technology

[0002] Conventionally, X-rays have been frequently used for observing the internal condition of a patient, and examinations, therapeutic treatments, and surgery are widely performed under X-ray fluoroscopy. However, there is a problem that X-rays are exposed to doctors who frequently perform operations.

[0003] In order to solve this problem, in recent years, 1^1 has been performed, and it has been proposed to perform surgery or treatment under fluoroscopy with 1^1 (Patent Documents 1 and 2).

[0004] Patent Document 1 describes that the surface of a medical device introduced into a living body is covered with a nickel oxide layer to visualize the medical device in 1^1. However, since nickel oxide is a metal oxide, it has no workability like metal, and can only coat the surface of the substrate. Further, Patent Document 1 neither describes nor suggests the problem of image artifacts in 1^1.

[0005] Patent Document 2 describes in 1^1 that an active marker or a passive marker is immobilized on the surface of a medical device to visualize the medical device. Further, it is described that paramagnetic, ferromagnetic, ferrimagnetic and antiferromagnetic metals, alloys, and metal compounds can be used as passive markers. However, these metals are bound to the surface of medical devices as markers. Further, Patent Document 2 neither describes nor suggests the problem of image artifacts in 1^1.

Prior art documents

Patent literature [0006] Patent Document 1: Patent No. 5078625

Patent Document 2: Patent No. 6281041

Summary of the invention

Problems to be Solved by the Invention

[0007] The inventor of the present application was a surgeon, and was examining an operation under MRI fluoroscopy. When an ordinary metal medical device was visualized in vivo by MRI, an image artifact due to the metal was generated, and the medical device was clearly identified. I found that there is a problem that it cannot be visualized. Unless the medical device can be clearly visualized, it is not possible to perform detailed work, and there is a therapeutic problem.

[0008] Therefore, an object of the present invention is to provide a novel medical device free from image artifacts in MRI. It is also an object of the present invention to provide a medical device that is not easily affected by magnetism even if it exists near an MRI apparatus.

Means for solving the problem

[0009] As a result of earnest research, the present inventor has determined that the metal constituting the medical device made of metal is high manganese-containing stainless steel, thereby preventing the generation of image artifacts in MRI and clarifying the medical device. We found that it can be visualized. Furthermore, it was found that by constructing the metal part of the medical device that can be present in the vicinity of the MRI apparatus with high manganese-containing stainless steel, the metal part can be prevented from being affected by magnetism.

That is, the present invention provides the following.

(1) A medical device composed of a metal (consistent essential ly of) or a medical device including a part composed of a metal (consistent essential ly of), wherein the metal is high manganese. A medical device containing stainless steel.

(2) The medical device according to (1), wherein the medical device is a medical device that may be used in the vicinity of the magnetic resonance imaging apparatus, or a component of the magnetic resonance imaging apparatus.

(3) The medical device is a magnetic resonance imaging guaranteed medical device (1) or ( \¥02020/174791 3 卩(: 17 2019/046312

2) The listed medical device.

(4) The medical device is a medical device at least temporarily wholly or wholly introduced into the living body, and the metal constituting the part introduced into the living body is high manganese-containing stainless steel. , The medical device according to any one of (1) to (3)

(5) The medical device according to any one of (1) to (4), wherein the manganese content in the high manganese-containing stainless steel is 13% by mass or more and 22% by mass or less.

(6) The medical device according to (5), wherein the high manganese-containing stainless steel has a composition shown in Table 1 or Table 2 below.

[001 1] [Table 1]

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[0012] [Table 2]

[0013] (7) The medical device includes a needle, an implantable medical device, a catheter-related device, steel items, tissue fixing wires, a robot-related device such as surgery and examination, an endoscope-related device, Alternatively, the medical device according to any one of (1) to (9), which is a dental material.

(8) The medical device according to (7), wherein the medical device is a needle, a stent or a staple.

Effect of the invention

[0014] According to the present invention, a novel medical device that does not cause image artifacts in 1^1 was provided for the first time. Since high manganese-containing stainless steel is stainless steel, it can be processed in the same manner as ordinary stainless steel, and thus various medical devices and parts thereof can be easily formed. Medical device of the present invention 〇 2020/174791 4 卩 (：171? 2019 /046312

With 1), the medical device in the body can be clearly visualized in 1^1, so it is possible to perform precise surgical operations accurately, which greatly contributes to medical treatment. Furthermore, by configuring the metal parts of medical devices (including the device itself) that are used in the vicinity of the 1^1 device with high manganese-containing stainless steel, the influence of the magnetic field generated by the device is reduced. It can be avoided.

Brief description of the drawings

It is a figure which shows the relationship between rolling rate and hardness.

FIG. 2 is a view showing 1^1 images observed in the following examples and comparative examples.

[Fig. 3] An explanatory diagram of Fig. 2.

MODE FOR CARRYING OUT THE INVENTION

[0016] The medical device of the present invention is a medical device made of metal, or a medical device including a part made of metal. That is, it is a medical device that is entirely made of metal such as a needle such as a puncture needle, an indwelling stent in a blood vessel, and an internal fixation screw, or a medical device that has a part made of metal at its tip portion such as a catheter. ..

[0017] The medical device of the present invention may be a medical device that is wholly or partially introduced into a living body by puncture, surgery, or the like, at least temporarily. Examples of the medical device of the present invention include various needles, various medical devices for implantation (implantation), catheter-related devices, small steel items, tissue fixing wires, robot-related devices such as surgery and inspection, etc. Examples include endoscope-related equipment and dental materials. More specifically, endoluminal endoprosthesis biopsy needles, markers and related instruments; breast tissue expanders and implants and related parts; cardiovascular catheters and accessories; carotid vascular forceps; coils and filters; dental implants, dentistry Appliances and dental materials;

Electrodes; Foley catheters with temperature sensors; halo vests and cervical fixation devices; heart valve prostheses and annuloplasty rings; hemostatic clips; wound sutures, tissue fixations, bone fixations, gastrointestinal tracts, vascular surgery, endoscopy Various staples for laparoscopic surgery, robotic surgery, etc. (Stabilizer force-tridge needles); Ocular implants and instruments; Orthopedic implants, materials and instruments; Ear implants; Arterial canals 〇 2020/174791 5

Patency disease (婩08),

Occluder for pellets and pellets

Penile implants; vascular access points, infusion pumps and catheters, robotic arms for surgery, robotic arms for examinations, flexible endoscope structural materials, flexible endoscope wires; sheath introducer set for angiography; Dilator; Cannula; Heart base maker and related parts; Stent; Artificial joint; Artificial bone; Bone fixing nail; Bone fixing metal wire; Bone fixing metal pin; Bone fixing screw; Bone fixing plate; Bone fixing Wires; surgical instruments such as a scalpel can be cited, but the invention is not limited thereto.

[0018] In the medical device described above, at least the metal constituting the portion to be introduced into the living body is high manganese-containing stainless steel.

[0019] Furthermore, as specifically described in the following examples, by constructing the needles from high manganese-containing stainless steel, the artifact in 1^1 was eliminated. Therefore, it is used in the 1^1 device itself or its parts or in the vicinity of the 1^1 device (the range affected by the magnetism generated by the 1^1 device, for example, within 2 meters from the 1^1 device) It has been clarified that it is possible to prevent the medical device from being influenced by magnetism by constructing the medical device, which is sometimes used, with high manganese-containing stainless steel. That is, the medical device of the present invention,

It can also be used as a medical device for drying or 1^1-33 drying 6). Therefore, in addition to the above-mentioned medical devices that are used at least temporarily in the living body, various medical devices that can be used in the vicinity of the 1^1 device or parts thereof that are not introduced into the living body are used as high manganese-containing materials. Containing stainless steel can be used as such medical equipment. For example, 1^1 device itself and its parts; surgical instruments such as forceps, tweezers, trays; stretchers and beds (for example, as a stretcher as it is). Parts such as beds that can be carried into a 1^1 chamber; drip tables, etc. can be mentioned, but are not limited to these.

[0020] The high manganese-containing stainless steel is a stainless steel having a high manganese content, and the manganese content is usually 10% by mass or more, preferably 13% by mass. \¥02020/174791 6 卩(: 17 2019/046312

Or more, more preferably 14 mass% or more, and further preferably 16 mass% or more. Stainless steel contains iron as a main component (50% by mass or more), chromium at 10.5% by mass or more, usually 12% by mass or more, and in addition to these, many also contain nickel. The manganese content is usually 22% by mass or less, preferably 20% by mass or less, because manufacturability deteriorates if the manganese content is too high. Any of the lower limit and the upper limit of the manganese content described above can be combined. The usual manganese steels 301, 31^301, 31^304, 31^304, 31^316, 31^316!, etc. on the market have a manganese content of 2% by mass or less. Since it is stainless steel, the carbon content is 1.2 mass% or less.

[0021] Such high manganese-containing stainless steel itself is commercially available, and commercially available products can be preferably used. An example of a preferred commercial product is high manganese-containing stainless steel manufactured by Nippon Yakin Kogyo Co., Ltd.

關1 511/1 (trade name) and 關17 (trade name) can be mentioned. Their chemical compositions are shown in Tables 3 and 4 below. As shown in Tables 3 and 4 below, the content of each element has a range, but these are differences due to lots.

[0022] [Table 3]

[0023] [Table 4]

[0024] Further, high manganese-containing stainless steel

Figure 1 shows the relationship between the cold rolling ratio and hardness of 17 (Nippon Yakin Kogyo Co., Ltd.)

17 Quoted from product information). Data for commercially available stainless steels 31^304 and 31^305 are also shown in this figure for comparison.

[0025] Hereinafter, the present invention will be specifically described based on Examples and Comparative Examples. However, 〇 2020/174791 7 卩 (: 171? 2019 /046312

The present invention is not limited to the examples below.

Example 1 Production of puncture needle

Stainless steel with high manganese content manufactured by Nippon Yakin Kogyo Co., Ltd.

Plate with a thickness of 17 mm (trade name) (thickness 0.7 (ä, Erichsen value: 11 .51 ä, !_0 (¾ 2.0) is used as the raw material, and the puncture needle ( The outer diameter was 0.891^, the inner diameter of the lumen was 0.501^, and the length was 1 5001111. The composition of the high manganese-containing stainless steel steel 17 (trade name) used in this example is as follows. Met.

[0027] [Table 5] 5 Go 17 (trade name)

[0028] Example 2, Comparative Example 1 1^1

The puncture needle manufactured in Example 1 (Example 2) or a commercially available puncture needle manufactured from 31^304 stainless steel (Comparative Example 1, the size including the lumen is the same as in Example 1) was applied to commercially available pork. It was punctured and observed with a commercially available 1^1 device. The magnetic flux density during observation was 0.3 Tesla. Figure 2 shows a photograph of the observation results, and Figure 3 shows an explanatory drawing. In FIG. 2, reference numeral 1 is a puncture needle used in Example 2, reference numeral 2 is a cross section of the puncture needle used in Comparative Example 1, reference numeral 3 is an image artifact observed under 1^1. , Reference number 4 is pork.

[0029] Stainless steel with high manganese content

There is no image artifact around the needle with a diameter of 0.898 1 ä made of 關17 (trade name) even when the nuclear magnetic resonance apparatus (1^1) is imaged. The image on the right side of Fig. 2 is a 1^1 image showing the longitudinal section of the needle by the 1^1 device, but the image of the metal wall of the needle is captured, and only a few 0.51 The lumen is clearly recorded in the image. This is the world's first video data as of August 2019. In comparison, the 31^304 stainless steel needle with a diameter of 0. 891 used in Comparative Example 1 was used for imaging the nuclear magnetic resonance apparatus as shown in the diagram on the left side of Fig. 2. Image artifacts in the form of fraudulent lily 3) occur in the area of circa 3 0 1 around the cross section, and the position of the needle is clearly depicted. 〇 2020/174791 8 卩 (：171? 2019 /046312

Can not. The longitudinal section of the needle of Comparative Example 1 was also observed, but the needle could not be seen at all due to image artifacts.

[0030] From the above results, it was confirmed that by forming the needle from stainless steel containing a high manganese, the image artifact due to the needle metal does not occur in 1^1.

Explanation of symbols

[0031] 1 Puncture needle used in Example 2

2 Cross section of the puncture needle used in Comparative Example 1

3 image artefact

4 pork

Claims

〇 2020/174791 9 卩(: 171? 2019 /046312 Claims

[Claim 1] A medical device made of metal, or a medical device including a part made of metal, wherein the metal is high manganese-containing stainless steel.

2. The medical device according to claim 1, wherein the medical device is a medical device that may be used in the vicinity of a magnetic resonance imaging apparatus, or a component of the magnetic resonance imaging apparatus.

[Claim 3] The medical device according to claim 1 or 2, wherein the medical device is a magnetic resonance imaging guaranteed medical device.

[Claim 4] The medical device is a medical device in which the whole or a part thereof is introduced into a living body at least temporarily, and the metal constituting the part introduced into the living body is a high manganese-containing stainless steel. The medical device according to any one of claims 1 to 3.

[5] The medical device according to any one of [1] to [4], wherein the manganese content in the high manganese-containing stainless steel is 13% by mass or more and 22% by mass or less.

6. The medical device according to claim 5, wherein the high manganese-containing stainless steel has a composition shown in Table 1 or Table 2 below.

[table 1 ]

[Table 2]

[Claim 7] The medical device is a needle, an implantable medical device, a catheter-related device, a steel accessory, a tissue-fixing wire, a robot-related device such as surgery and examination, an endoscope-related device, or a dentistry device. A material according to any one of claims 1 to 6. \¥0 2020/174791 10 卩 (: 17 2019/046312

Medical equipment.

8. The medical device according to claim 7, wherein the medical device is a needle, a stent or a staple.