JPH09192114A - Artifact control magnetic resonance instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To use an instrument while controlling the formation of artifact to an image in the case of MRI by composing the medical instrument of titanium alloy containing the specified ratio of aluminum, the specified ratio of vanadium and titanium consisting of the remaining part. SOLUTION: A puncture instrument 1 is an entirely slender hollow tubular body structure 2 having a base end part 3 and a top end part 4 and has a central lumen 5 formed from a cylindrical wall body having an outer face and an inner face (lumen formation plane). The base end part 3 and top end part 4 of the instrument 1 are opened outside so as to pass fluid or other flowing materials through the lumen 5 of the body structure 2. In this case, the puncture instrument 1 is composed of aluminum from 2.5% to 7%, vanidium from 2% to 5% and titanium consisting of the remaining part for 100%. Further iron less than 0.3% is contained as well.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to artifacts produced in diagnostic images by medical and surgical instruments.
t) ie control of artifacts. The present invention both increases and decreases the artifacts created by the instrument on the diagnostic image. The present invention also relates to a novel penetrating device configured to reduce the likelihood of structural defects during use.
The medical and surgical instruments of the present invention are particularly suitable for use in diagnostic imaging procedures, such as magnetic resonance imaging (MRI) procedures.

[0002]

2. Description of the Related Art Medical imaging technology has made rapid progress in recent years. A major driving force for such progress is nuclear magnetic resonance (NM).
The use of R) provided a clinical magnetic resonance imaging (MRI) system.

The principles of NMR were first described around 1946, but only 19 MRI procedures were performed.
Since 1973. Since 1973, MRI has rapidly established itself as an excellent imaging technology for X-rays, CT scans and ultrasound in some cases. For example,
MRI can be selected as the technique used for high resolution imaging of soft tissues. Also, the proper use of MRI technology allows the identification of areas of edema, bleeding, tumors (eg bone tumors) and bloodshed, which were often difficult to identify when using eg X-ray CT. .

Numerous NMR currently available
Are configured to create a magnetic field using a cylindrical superconducting magnet that can interfere with patient access during scanning. More recently, open MRI systems have become available that can allow patient access during imaging procedures. This allows the physician to perform diagnostic or therapeutic procedures while performing MRI scans. This new field in medicine is called MRT (Magnetic Resonance Therapy).

[0005]

Unfortunately, however, many of the instruments that can be used to provide treatment during image manipulation have the disadvantage of creating artifacts in the resulting image. .

Therefore, there is a need for a material that can be used during imaging diagnostic procedures, especially MRI, with controlled formation of artifacts on the resulting images.
There is also a long-felt need for an instrument that can be used during scanning with less obstruction to visual recognition during scanning. Further, there is a need for an instrument that minimizes visual obstruction during scanning and eliminates structural imperfections during use. Furthermore, there is a long felt need for the development of techniques for controlling instrument artifacts due to the magnetic properties of the material.

[0007]

SUMMARY OF THE INVENTION The present invention is directed to a medical device that controls the artifacts caused by the device that may appear when used in the field of diagnostic imaging. it can. Suitable materials for the device according to the invention include titanium alloy compositions,
Includes plastics, glass fiber reinforced plastics and ferromagnets.

In one embodiment, according to the present invention,
It is composed of a titanium alloy containing 2.5% to 7% aluminum, 2% to 5% vanadium, and 100% titanium making up the balance. Medical devices also
It can contain up to 0.3% iron. In one example, the medical device can include titanium as ISO 3.7034 or 3.7035.

In accordance with the present invention, the low or non-artifact-causing artifact-causing medical device can also be formed from glass fiber reinforced plastic.

In another embodiment, according to the present invention,
Methods for removing magnetic contaminants from the surface of alloy compositions, such as alloy-containing medical devices, are provided. The advantage of low artifact medical devices including alloy materials is that tooling of medical devices using tools that include ferromagnetic materials.
May be lost due to. However, the present invention
Wet chemical etching of the surface of the alloy fixture can reduce magnetic contaminants. According to the method of the present invention, the wet chemical etching composition comprises an acid HX where X is a halogen.
And nitric acid. The contaminated alloy is then contacted with the wet chemical etching composition described above.

The present invention is also capable of enhancing the artifacts created by medical instruments on diagnostic images. According to this embodiment, the medical device can have at least one lumen containing a removable artefact material. In a preferred embodiment, the medical device according to this aspect of the invention is a catheter.

In the preferred embodiment, a catheter can be described which creates enhanced artifacts in MRI images. According to this embodiment, the catheter comprises at least two lumens, one of which has a closed tip. Artifact material suitable for creating a positive or negative contrast is inserted into the closed lumen. Suitable artifact materials include positive and negative contrast agents such as ferromagnetic fibers.

Alternatively, the artifact-forming medical device can be obtained by applying a thin layer of artifact material to the medical device that is free of artifacts. Various methods of depositing the artifact material on the artifact-free material are known in the art and disclosed herein.

The present invention also provides a device that includes both artifact and non-artifact materials. In a preferred embodiment, such a device comprises, for example, a "tumor localizer". In this example, the tumor localizer is formed from a rigid outer tube, an artifact-free tube removably inserted into the rigid outer tube, and an artifact material removably inserted into the artifact-free tube. And a localized wire.

The low or non-artifact instruments of the present invention are generally capable of eliminating the loss of structural shape when penetrating or excising physiological tissue. However, the present invention also provides an improved piercing end that can exhibit greater resistance to twisting or bending when piercing tissue.

[0016]

A device for reducing artifacts can be made using the titanium alloy composition or plastic composition described above. The equipment that enhances artifacts is
It can be made by incorporating the artifact-forming material into an artifact-free device. Such an instrument is suitable for use in an imaging diagnostic procedure, eg a magnetic resonance imaging procedure. The penetrating end for penetrating the instrument can be used to perform diagnostic and therapeutic procedures during medical and surgical procedures.

[0017]

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to the control of artifacts caused by medical and surgical instruments used in diagnostic imaging. In one embodiment, the present invention provides medical and surgical instruments of alloy compositions that cause low artifacts on diagnostic images. In another embodiment, the invention enhances artifacts caused by medical and surgical instruments on diagnostic images. According to the present invention, "controlling" image artifacts means increasing or decreasing the image artifacts as desired by the operator. The instrument of the present invention is suitable for use in diagnostic imaging procedures, for example in magnetic resonance imaging (MRI) scanning.

The present invention also provides a piercing tip structure of a piercing device having an increased ability to withstand structural deformation during piercing. This is particularly advantageous when made from "soft" materials, which may exhibit a tendency to deform when a device such as a needle is inserted through certain tissues.

I. Low artifact materials for medical and surgical instruments

As used herein, the term "artifact" is an artificial or distorted presence in a diagnostic image caused by an instrument, procedure, or other form of intervening procedure that occurs during an image procedure. Means an image. Artifacts formed on a diagnostic image by a given procedure or material will vary. According to the invention, the "artifact material" can be any material that exhibits a clear artifact in the image, for example steel or a ferromagnetic material.
Such artifacts can distort or interfere with the interpretation of diagnostic images. However, such artifact material can also facilitate detection of the device causing the artifact. An instrument made from an artifact material having a dimension "X" often produces an artifact in the image that is often greater than 3X.

In accordance with the present invention, "low artifact" material is capable of producing artifacts in an image that are not significant enough to prevent accurate interpretation of the image. Such materials that cause "low artifacts" are described in Section I herein.

"No artifacts"("artif"
Act free ") materials are materials that produce minimal artifacts in diagnostic images, for example some plastics. These materials are often the size of water (ie free protons) and are magnetic. It consists of sensitivity.

In one embodiment, according to the present invention,
Alloy materials have been provided that form "low artifacts" for use in diagnostic imaging procedures. In one embodiment of the present invention, the alloy composition of the present invention is useful in the manufacture of medical devices used in performing diagnostic imaging procedures. As used herein, "medical" device ("medic")
al "instrument refers to a device that can be used in performing a diagnostic or therapeutic procedure in medical or surgical procedures, such as a biopsy or biopsy needle, an injection needle, a catheter,
Includes forceps, stethoscope and other similar devices.

One of the advantages of medical devices made with the compositions of the present invention is that the presence of the device in the field of image processing systems such as, for example, MRI, reduces distortion of the imaged structure. Therefore, the accuracy of image interpretation can be improved. Furthermore, although the device of the present invention is particularly suitable for use in open MRI imaging procedures, the device of the present invention may also be used in the field of non-open (conventional) MRI and other diagnostic imaging techniques or therefor. It was found that it can also be used in fields close to.

In this specification, "open MRI"("
"Open MRI") refers to an MRI imaging system having a magnetic field shaping magnet arranged to allow access to a patient during an MRI scan.

The composition used to make the device according to the invention is preferably a titanium alloy. Titanium (T
i) is a particularly useful component of the alloy because the defects produced in the images formed by MRI are low artifacts. American Society for Testing and Materials (ASTM) standard grade 1-5 titanium can be used to provide only low artifacts in the image. However, in general, this grade of titanium is used in instruments used to ablate or penetrate physiological tissues such as skin, muscle, fascia, blood vessels, parenchymal organs, and the like. Is too soft.

"Soft" as used herein
Alternatively, the term "soft" refers to a material composition that tends to lose its structural shape when used to ablate or penetrate physiological tissue. Such loss of structural shape includes, for example, bending of the needle tip, blunting of the needle tip or blunting of the instrument's sharp edge. In one embodiment, the present invention overcomes the problems of soft materials such as titanium, preferably by using titanium alloys. The titanium component of the titanium alloy suitable for the present invention is at least 80 by weight.
%, Preferably greater than 85% can be present.

In the preferred embodiment, the titanium alloy may also include the element aluminum (Al).
Suitable aluminum for the compositions of the present invention include aluminum that does not abrogate the low artifact properties of the titanium alloys of the present invention when combined to form the titanium alloys of the present invention. Aluminum can be present in the titanium alloy in an amount of 1-10% by weight, preferably 2.5-7%.

The titanium alloys of the present invention may also include compounds or materials that provide the alloy with a large "hardness" or "hardness." As used herein, the term “hard” and its derivatives, when referring to the alloys of the present invention, refers to a device made from the composition of the present invention as a physiological tissue. It refers to the property of a material that provides deformation resistance when used for ablation or penetration. The hardness-enhancing alloy component is preferably harder than titanium. One such preferred material is vanadium (V). The vanadium component of the titanium alloy of the present invention can be present in the range of 1% to 5%, preferably 1.5% to 4%.

The titanium alloy of the present invention also contains a small amount of iron (F
e) can be included.

While other metallic materials can be added to the compositions of the present invention, the components described herein can provide a preferred alloy composition for forming medical devices. In an exemplary embodiment, the medical device of the invention comprises:
Titanium alloy according to (ASTM) Grade 9 or Ti-3
Al-2.5V (ISO) 3.7194 (or 3.7)
195). The amounts of the components of the alloy according to this example of the invention are 94.5% Ti, 3.0% Al and 2.5% V.

Another suitable titanium alloy useful in accordance with the present invention is an alloy according to ASTM Grade 5, namely ISO.
There are 3.765 or 3.7165. The amounts of alloying components according to this embodiment of the present invention are 90% Ti and 6% Al.
And V is 4%. These titanium alloys are available from UTI-Uniform Tube, located in Collegeville, PA 19426-0992.
s Inc. ), Fastener Technology Corporation (Fast), Fulton Avenue 7415, North Hollywood, CA 91605.
ener Technology Corporati
on) or Alphatec Manufacturing Inc., 42-160, State Street, Palm Desert, California 92211.
ing Inc. ).

In another embodiment, a titanium alloy suitable for the device according to the invention comprises Ti in an amount greater than 95%,
2.5% -3.3% Al and 2.0% -2.5% V
And As an example of a particularly preferred titanium alloy containing greater than 95% titanium, Ti-3Al-2.5V
There is. A particularly preferred embodiment uses titanium as ISO 3.7.
034 or 3.7035.

In yet another embodiment of the present invention, the titanium alloy of the present invention may also contain a small amount of iron (Fe). There are two such iron-containing compositions: 5.5% to 6.75% Al, 3.5% to 4.5% V,
A composition in which Fe is 0.3% or less, 100% of the remaining portion is Ti, Al is 2.5% to 3.5%, and V is 2.
There is a composition in which 0% to 3.0%, Fe is 0.25% or less, and the remaining 100% is Ti.

The titanium alloy of the device of the present invention can be used in medical or surgical diagnostic or therapeutic procedures. The instrument is particularly advantageous for use in diagnostic imaging procedures, such as MRI scanning. Medical devices according to the present invention include, for example, biopsy or biopsy needles, epidural needles, injection needles, scalp blades, trocars, forceps, stethoscopes, scalpels and the like. Medical devices can be made from the titanium alloy compositions of the present invention using methods known in the art. Such methods include, for example, milling,
There are drilling and grinding.

According to the invention, when used to use an injection needle or a biopsy needle, the material of the invention is
It can be used to make needles with an outer diameter of 18 mm or less or more than 18 mm. Preferably, the needles and biopsy needles of the present invention have a diameter of 0.3 mm (0.
062 inch) to 11.5 mm (0.445 inch)
It is. The injection needle, epidural needle and biopsy needle of the present invention generally have a length of about 24 mm to 500 mm, preferably about 50 mm to 200 mm. The trocar of the present invention may preferably have an outer diameter of 30 mm or less. Preferably, the trocar of the present invention has a diameter of about 5 mm to 10 mm. A typical trocar length is about 50 mm to 250 mm, preferably about 100 mm to 150 mm.

When making the device of the present invention using any of several methods known in the art, it is not common to use a tooling tool that contains a magnetic material and is itself magnetic. Absent. Thus, the titanium alloys of the present invention can include abrasives on their surface that form higher image artifacts after tool maintenance as compared to the tool before tool maintenance. The higher image artifacts prior to tool servicing are believed to be due to contamination of the magnetic surface of the tool serviced instrument by the remnant of the iron-based tool used to make the instrument.

Therefore, according to another aspect of the present invention, there is provided a wet chemical etching method for reducing the surface magnetism of an alloy instrument contaminated with a magnetic substance. Although the inventor does not wish to be limited to one theory, it is believed that wet chemical etching removes iron contamination from the instrument. The wet chemical etching composition can be obtained by combining an acid HX in which X is a halogen and nitric acid. A preferred wet chemical etching composition is 40
% Hydrofluoric acid (HF) 12 ml and 65% nitric acid (HN
It is obtained by combining 20 ml of O3) and 1800 ml of H2O. Etching is carried out by immersing the machined tool in the solution for a short time, for example 10 to 120 seconds. The rate of etching can be slowed by diluting with water.

II. Enhanced artifacts with artifact-free medical devices

Medical devices made of plastic or ceramic can be used in MRI. However, the use of such materials renders the instrument substantially "artifact-free" and may have the disadvantage of not being able to form artifacts in the diagnostic image if such artifacts are desired. Therefore, these instruments cannot appear directly in the image. Rather, these instruments are only visible by detecting the geometrical displacement of the tissue caused by the instruments during the procedure. Guide of such instruments, eg catheters, under MRI is extremely difficult.

Therefore, according to another embodiment of the present invention, the visibility of artifacts and thus of instruments used during image processing can be increased. Although the principles and methods for enhancing image artifacts described herein can be used for many instruments, one example may be application to catheter systems.

According to this embodiment, the catheter is a flexible tube having one or more lumens for passage of medical devices or flowable materials. In the preferred embodiment, the catheter has at least two lumens. One of the two lumens is configured and arranged to include an artifact material that creates an artifact in the diagnostic image. Such artifact material can create negative or positive contrast artifacts in diagnostic images. Artifact materials suitable for the present invention include, for example, lanthanide-based materials such as gadolinium and ferromagnetic materials or compounds.

In one embodiment, at least two lumens are provided and at least one lumen is closed at the tip. According to this embodiment, the closed-end lumen is filled with a flowable liquid material containing an artifact-forming contrast agent. Such liquids can include substances such as, for example, gadolinium or other substances other than lanthanide-based.

Referring now to Figures 10a-10d, there are shown four cross-sectional views of a preferred catheter having at least two lumens. In accordance with the present invention, a catheter may have at least one lumen 52a-d for containing an artifact material and a second lumen 53a-d that acts as a working channel for tools, liquid aspiration or infusion. it can. Flexible, rounded members 51a-d separate the lumens. As shown in Figures 10a and 10c, lumens 52 (a and c) and 53 (a and c) can have different diameters, or both lumens can be formed to the same diameter as shown in Figure 10b. You can also Further, as shown in FIG. 10c, in addition to the lumen 52c for containing the artifact material,
One or more working lumens may be provided, for example lumens 53c and 54. The outer shape of the catheter can be any shape suitable for the function of the catheter. Two examples, circular and elliptical, are shown in Figures 10a-d.

Generally, the lumen for the artifact material is closed at the tip. FIG. 10d illustrates a two lumen catheter with a ferromagnetic material, eg, wire 56, in the lumen containing the artifact material 52d. Further, if possible, although not shown, it may be a single lumen catheter having a workable lumen-like artifact material that can be removed.

FIG. 11 shows the catheter A- of FIG. 10a.
It is a longitudinal cross-sectional view cut along the line A ′. A liquid artifact material, such as a contrast agent, can be used in the lumen to obtain a positive contrast, for example. In the same manner as the contrast liquid, metal fibers 56 (FIG. 10d) can be inserted into the lumen to control artifacts.

According to the invention, FIGS. 12 and 13a-
In another example, shown in c, a "tumor localizer" is provided. According to this embodiment, a localizing wire 45 formed of an artifact material is inserted into an artifact-free tube 42 formed of, for example, plastic or ceramic. Then, both the wire 45 and the artefact-free tube 42 are connected to the fluid line, syringe, etc. by a connector 44
Is inserted into a rigid tube 43 with low or no artifacts connected through. Preferably, the localized wire 45 “ancises” within the tissue.
“Hor)” has a bent portion 41 at the tip.

13a-c, the procedure of use of the tumor localizer is outlined. In FIG. 13 a, a localized wire 45 and an artifact-free tube 42 are inserted into an outer tube 43. In use, the assembly is pushed through the tissues of the human body until it reaches the tumor to be localized without penetrating the tumor. The outer tube 43 is then pulled back, as shown in Figure 13b, leaving only the wire 45 and tube 42 in the tissue. Since the wire 45 is an artifact material, it forms artifacts and thus can act as a guide in MRI images. The small diameter of wire 45 provides a low level image artifact with low image distortion as an artifact material.

To localize the tumor in front of the "anchor" construct 41, the tube 42 is pulled posteriorly, leaving only the localizer wire 45 in the tissue. Since the anchor is configured as a spring device, it holds the wire 45 in place. Once the wire 45 is located within the tumor, the surgeon can use the wire as a guide to localize the tumor and surgically remove it.

Suitable "low artifact" materials for the outer tube 43 are described in Section I herein. A typical material for the artifact-free tube 42 can be any plastic, rubber or ceramic. Plastics include, for example, polypropylene, polyethylene and polyurethane, and rubbers include, for example, silicone. Suitable materials for the localized wire include ASTM F563 consisting of 15-25% nickel, 18-22% chromium, 4% titanium, 4% molybdenum and 6% iron. Nickel-chromium alloys such as 78 are included. This material is an Institute Strutmann located in Badenburg 4437, Switzerland.
Straumann) from the trademark SYNTACOBEN
You can purchase items marked with. Similar materials are available at General Resources SA located in Beinne 2501, Switzerland.
s SA) under the trademark NIVAFLEX can be purchased. Preferably, the tumor localizer needle has a length of 50 mm to 150 mm, typically 100
mm to 150 mm. Preferably, the localized wire has a diameter of 0.1 mm to 0.5 mm, often
It is 0.2 mm to 0.3 mm. Preferably, the overall diameter of the assembly is between 1 mm and 4 mm, typically between 1.5 mm and 2.5 mm.

Plastic instruments are generally not visible in MRI images because they do not contain ferromagnetic compounds. To visualize the plastic material, the metal material can be vaporized and formed into a layer on the plastic.

However, in general, many plastics cannot be used in some types of medical devices because the material is too "soft". When high "stiffness" is required, glass fiber reinforced plastics can be used to provide materials suitable for certain medical devices, such as excision devices. The methods described below for enhancing the visualization of artifact-free materials are suitable for plastic and glass fiber reinforced plastic materials. Methods of glass fiber reinforcement are known in the art.

FIG. 14 shows a plastic tube for MRI.
The mode which forms so that it can be visually recognized in an image is shown. In particular, evaporation, sputtering, plasma deposition,
A thin layer of artefact material is deposited on the plastic tube using chemical vapor deposition or other thin film deposition methods known in the art. The layer 60 can be formed by a thin film forming technique. Preferably, the film thickness is about 2-10μ
m. Alternatively, a thin film or foil of artifact material can be applied to the plastic tube 61 using conventional means (eg gluing).

III. Improved penetration end

The titanium alloy device of the present invention is generally capable of withstanding the loss of structural shape that occurs when piercing or excising physiological tissue. However, in another embodiment, the present invention provides a penetrating device, for example, a biopsy needle, an epidural needle having an improved “penetrating end” to enhance anti-distortion during penetration.
It is also suitable for injection needles and forceps. The penetrating end of the device
An improved cutting edge and tip penetrating tip is provided. The shape of the tip of the present invention can also reduce structural deformation during penetration by reducing resistance during breakage. Such a shape also preferably reduces trauma to the tissue during penetration.

Referring now to FIG. 1, the "piercing device" 1 of the present invention is a generally elongate hollow tubular structure 2 having a proximal end 3 and a distal end 4.

FIG. 2 is a cross-sectional view taken along the line AA ′ of FIG.
It has a central lumen 5 defined by a cylindrical wall 11 having

Referring to FIG. 1, the proximal end portion 3 and the distal end portion 4 of the device 1 are open to the outside so that fluid or other fluent material can be passed through the lumen 5 of the structure 2. .

In use, the base end 3 of the penetrating device 1 is
In many cases, it may be oriented towards the operator to provide a working end, such as a mounting structure 6 for eg a syringe, a fluid dosing tube or the like. The "tip" 4 of the device 1 has a "penetrating end" 7 that is oriented away from the operator when used to penetrate tissue. As used herein, the "penetrating end" 7 of the device refers to the end of the device used to penetrate a membrane, such as physiological tissue, to provide an opening in the tissue through which the device penetrates. . "The distal end or part (distal most) of the" penetrating end "
“aspect)” has the appearance of a “penetration edge”. The "penetration edge" is the edge of the instrument that actually cuts or penetrates the membrane during penetration. What is fundamental to the invention is that the penetration edge is formed from the lumen forming surface of the cylindrical wall.

A preferred embodiment of the penetration end of the present invention is shown in FIG.
6 to 6 will be further described.

FIG. 3 is a perspective view of an embodiment of the penetrating end portion 15 of the penetrating device 10 of the present invention. 4 is a side view of the penetrating end 15 of the device 10 shown in FIG. 3, with the lumen opening 16 at the tip facing upward. FIG. 5 is a front view of the same device 10, showing a lumen opening 16 and a piercing edge 17. FIG. 6 is a rear view of the instrument 10, rotated 180 degrees with respect to FIG. The penetration edge 17 is still visible in this view. 3 to 6
The proximal end of the device is not shown.

According to the present invention, the tip side of the penetration end 15 is a "penetration edge" 17. The piercing edge 17 is the distal side of the cylindrical wall 18 of the device 10 that is capable of piercing a membrane, eg, physiological tissue, by piercing or excising. The tip side of the penetration edge portion 17 is tapered toward the penetration tip 19 at the tip.

Referring to FIG. 5, a front view, the piercing edge 17 of the device 10 defines a distal lumen opening 16. The distal lumen opening 16, as shown in FIG. 1, is oval shaped and comprises a base base 20 and a sharpened tip 21 oriented in the same manner as the proximal and distal ends 3 and 4 of the instrument. Preferably, when the instrument is viewed directly down (ie, orthogonal to the horizontal direction), the elongated side of the instrument horizontal and the lumen opening 16 at the tip (see FIG.
The perforation edge 17 that faces upwards and defines the distal lumen opening 16 (as shown in FIG. 1) is "tear drop".
Make 24. Therefore, the penetrating edge portion 17 is tapered toward the sharp tip 21 of the teardrop 24, and the penetrating tip 1
Terminate at 9. The pointed tip 21 of the teardrop 24 provides a "sharper" piercing edge 19 than the piercing tip formed by, for example, an oval piercing edge.

Next, referring to FIG. 4, when the elongated side of the device is horizontal and the lumen opening 16 at the distal end faces "up", the side surface of the penetration edge 17 is
From the base 20 of the distal lumen opening 16 to the lumen opening 16
Is inclined toward the sharp tip 21 of the. In one embodiment, as shown, the slope can be parabolic, which allows the perforation edge 17 to be concave on the sides. Thus, in accordance with the present invention, the penetration end 15 taper can be of at least two dimensions. One taper defines a "tear" shape 24 as shown in FIG. 5, and the other taper defines a "parabola" shape shown in the side view of FIG.

The components surrounding the perforation edge 17 will be further described with reference to FIGS. As shown in FIGS. 3 to 6, the cylindrical wall body 18 extends from the outer surface of the wall 25 to the wall 26.
Is chamfered to the inner surface of the to provide a chamfered surface 27 surrounding the lumen opening 16. As shown in FIG.
The chamfered surface 27 and the tear-shaped lumen opening 24 are preferably symmetrical on both sides with respect to the axis 28. The chamfered surface 27 is in contact with the piercing edge 17 and is preferably "tear-shaped". Basic to the device of the present invention is that the chamfered surface 27 is formed so that the piercing edge 17 of the device 10 is the inner or lumen forming surface 26 of the cylindrical wall 18. Therefore, the chamfered surface 27 is defined by the penetrating edge portion 17 and is on the lumen side (l
uminal aspect). Chamfer 27
Is also defined as "anti-lumena defined by and in contact with the outer surface 25 of the cylindrical wall 18.
l) ”side 30.

Referring further to FIGS. 3-6, the distal end or tip of the penetrating end 15 of the device 10 of the present invention is a "penetrating tip" 19. Preferably, as shown in FIGS. 3 and 4, the penetrating tip 19 of the present invention has a “beak” shape 31. In the present invention, the preferred "beak" shape 31 has a "piercing tip" 32. Penetration tip 3
The three surfaces defining 2 are the tip side of the inner surface 26 of the cylindrical wall 18 and the tip side of the chamfered surface 27 that is symmetrical in both directions on the lumen forming side.

Preferably, the intersection point on the tip side of the chamfered surface 27 which is symmetrical in both directions is also the "tip tip piercing edge".
33 is formed. The tip penetrating edge also intersects the inner surface 26 and the outer surface 25 of the cylindrical wall 18 at the leading edge.

In a particularly preferred embodiment, the "beak" shape is formed as shown in FIGS. 15-18 which show micrographs corresponding to FIGS. 3-6, respectively. These photographs are provided to define in detail a particularly preferred embodiment of the penetration end of the present invention. With such a photo,
The cooperation of the components of the preferred penetrating tip of the present invention can be ascertained.

7 to 9 show another embodiment of the penetrating device of the present invention. According to this embodiment, both side surfaces 60 are formed on the penetrating edge portion 61 adjacent to the proximal end side 63 of the lumen opening 64. This surface can enhance the stability of the tip penetrating tip.

Referring to FIGS. 3-6, the penetrating tip 32 and the tip penetrating edge 33 during typical use.
Is the portion of the piercing end that initially penetrates physiological tissue during piercing.

According to the invention, the penetrating device has a length of about 5
0 mm to 200 mm, preferably 100 mm to 15
It can be 0 mm. The inner diameter of the device can be, for example, about 0.2 mm to 10.0 mm, preferably about 0.5 mm to 2.0 mm for a needle.
The outer diameter of the needle of the present invention is about 0.4 mm to 11.0 mm,
Preferably, it can be about 0.7 mm to 2.2 mm. The preferred wall thickness of the cylindrical wall of the needle of the present invention is about 0.09 mm to 0.11 mm.

The distal tip of the piercing device of the present invention can be coated with a hard alloy such as titanium nitride, which can enhance the excision ability and reduce the risk of deformation during piercing. can do.

The above description details the medical devices and methods of the present invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

[0074]

As described above, the present invention provides a material that can be used while controlling the formation of artifacts on an image obtained during an image diagnostic procedure, particularly an MRI procedure. can do. In addition, it is possible to provide an instrument that can be used during scanning with less hindrance to visual recognition during scanning. Furthermore,
Techniques can be provided for controlling instrument artifacts due to the magnetic properties of the instrument and the material that can minimize visible obstruction during scanning and eliminate structural defects during use.

[Brief description of the drawings]

FIG. 1 is a side view showing an embodiment of a penetrating device according to the present invention.

FIG. 2 is a cross-sectional view taken along the line AA ′ of the penetrating device shown in FIG.

FIG. 3 is a perspective view showing an embodiment of a piercing end portion of the piercing device of the present invention.

4 is a side view of a piercing end portion of the piercing device shown in FIG.

5 is a front view of the penetrating end of the device shown in FIGS. 3 and 4. FIG.

6 is a rear view of the piercing end of the device shown in FIGS. 3-5, in which the device has been rotated 180 degrees from the state of FIG.

FIG. 7 is a side view showing another embodiment of the penetration end of the penetration device of the present invention.

8 is a front view of the device shown in FIG. 7. FIG.

9 is a perspective view of the instrument shown in FIGS. 7 and 8. FIG.

10 (a) (b) (c) (d) are different cross-sectional views of lumens 52 and 53 of a catheter according to the present invention.

FIG. 11 is a cross-sectional view taken along the line AA of the catheter shown in FIG.

FIG. 12 is a side view of a tumor localization device according to the present invention.

13 (a), (b) and (c) are longitudinal cross-sectional views of the device shown in FIG. 12 in different steps during use.

FIG. 14 is a perspective view of a non-artifact material device coated with an artifact material.

FIG. 15 is a micrograph showing a perspective view shape of a preferred embodiment of a penetration end of a penetration device.

16 is a micrograph showing a side view shape of a penetration end portion of the embodiment shown in FIG.

FIG. 17 is a micrograph showing a front view shape of a penetration end portion of the embodiment shown in FIGS. 15 and 16.

FIG. 18 is a micrograph showing a rear view shape of the penetration end portion of the embodiment shown in FIGS. 15 to 17.

[Explanation of symbols]

 1 Penetrating Device 2 Tubular Structure 3 Base End 4 Tip 5 Lumen 6 Structure 7 Penetrating End 10 Penetrating Device 11 Cylindrical Wall 12 Outer Surface 13 Inner Surface (Lumen Forming Surface) 15 Penetrating End 16 Tip Lumen Opening 17 Penetrating Edge portion 18 Cylindrical wall body 19 Tip penetration tip 20 Base portion 21 Sharp tip 24 Tear shape 25 Wall body 27 Chamfered surface 28 Axis 29 Lumen formation side 30 Non-lumen formation side 31 Beak shape 32 Penetration tip 33 Tip tip penetration edge portion 41 Bend Part 42 Tube 43 Tube 44 Connector 45 Localized Wire 51a-d Flexible Member 52a-d Lumen 53a-d Lumen 54 Lumen 56 Wire, Metal Fiber 60 Both Sides 61 Penetration Edge

Claims (24)

[Claims] 1. Aluminum from 2.5% to 7% and 2%
A medical device that provides low artifacts during diagnostic imaging, characterized in that it consists of ˜5% vanadium and 100% titanium that makes up the remainder. 2. The medical device according to claim 1, further comprising 0.3% or less of iron. 3. The device comprises 5.5% to 6.75% aluminum, 3.5% to 4.5% vanadium.
The medical device according to claim 1, wherein the medical device is composed of 0.3% or less of iron and 100% of titanium constituting the remaining portion. 4. The device comprises 2.5% to 3.5% aluminum, 2% to 3% vanadium, 0.25% or less iron, and 100% the remaining titanium. The medical device according to claim 1, wherein the medical device comprises: 5. The device of claim 1, wherein the device comprises titanium as ISO 3.7034 or 3.7035.
A medical device according to claim 1. 6. A method for removing magnetic contaminants from the surface of an alloy material, comprising: (a) (i) an acid, HX in which X is a halogen, and (ii)
A method comprising: preparing a wet chemical etching composition comprising nitric acid; and (b) contacting the alloy material with the wet chemical etching composition. 7. 2.5% to 6.75% aluminum, 2.0% to 4.5% vanadium, 0.3% or less iron, and 100% remaining titanium. And (a) a hollow tubular structure having a lumen defined by a cylindrical wall having an inner surface and an outer surface and having a tip opening formed therein; (b) (i) a tip piercing edge portion and ( ii) a distal piercing end having a piercing tip, wherein the distal piercing edge is formed from the inner surface of the cylindrical wall body. 8. (a) a hollow tubular structure having a lumen defined by a cylindrical wall having an inner surface and an outer surface and having a tip opening formed therein; (b) (i) a tip piercing edge portion and ( ii) A distal piercing end portion having a piercing tip, wherein the distal piercing edge portion is formed from the inner surface of the cylindrical wall body. 9. The piercing device of claim 8, further comprising a tip piercing edge. 10. The penetrating device according to claim 8, wherein the penetrating tip has a beak shape. 11. The penetration device according to claim 8, wherein the distal lumen opening is formed in a teardrop shape. 12. The piercing device according to claim 8, wherein the distal piercing edge portion has a parabolic inclined portion that is tapered toward the piercing tip. 13. The tip lumen opening is teardrop shaped, and the tip piercing edge has a parabolic ramp that tapers to the piercing tip. Piercing device. 14. The piercing device according to claim 8, wherein the distal piercing device is formed in the shape shown in FIGS. 15 to 18. 15. A medical device for forming artifacts in a diagnostic image, comprising: a) a medical device having at least one lumen; and b) an artifact material inserted into the at least one lumen. 16. The medical device according to claim 15, wherein the medical device is a catheter. 17. The medical device according to claim 15, wherein the artifact material is a positive contrast agent. 18. The medical device according to claim 15, wherein the artifact material is a negative contrast agent. 19. The medical device according to claim 15, wherein the artifact material is a lanthanide. 20. A) comprising at least two lumens,
A lumen is closed at the tip, and b) an artifact material suitable for creating a positive or negative contrast in the magnetic resonance image when inside the lumen at the closed tip. A catheter for use in magnetic resonance imaging, comprising: 21. The catheter of claim 19, wherein the artifact material is a ferromagnetic fiber. 22. A medical instrument for use in a diagnostic MRI procedure, which is made of glass fiber reinforced plastic. 23. A method comprising: (a) selecting an artifact-free medical device; and (b) depositing a thin layer of artifact material on the artifact-free medical device. A medical device that forms an artifact in a diagnostic image. 24. An (a) rigid outer tube, (b) an artefact-free tube removably inserted into the rigid outer tube, and (c) an artefact-free tube having a tip. A localizer wire made of an artifact material inserted into the tumor localizer wire, the localizer wire being configured to have a bend at the tip.