JP2003116776A - Leading end direction detecting device and detecting method for medical insertion instrument into biotissue - Google Patents

Abstract

PROBLEM TO BE SOLVED: To achieve size reduction to reduce a bad influence upon the biotissue by performing easy and smooth insertion into a narrow biotissue and to detect the current pointing direction of the inserted distal end surely and with good accuracy. SOLUTION: An insertion part 3 into the biotissue of a catheter 2 as an example of a medical insertion instrument is formed of magnetic material having flexing property and high magnetic permeability. A permanent magnet 5 for generating a magnetic field is attached to the inserted base end part of the insertion part 3 made of high magnetic permeability magnetic material. Separately from the catheter 2, a magnetic sensor 6 is provided for detecting a leak magnetic field from the tip of the insertion part 3 to detect the current pointing direction of the insertion part 3.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention mainly relates to an indwelling device including a drainer tube, a bile duct stent, a high-calorie infusion tube, which forms a discharge path for catheters, endoscopes, body fluids, etc., and guidewires thereof. As described above, the present invention relates to a device for detecting a distal direction of a medical insertion tool into a biological tissue for externally detecting the direction in which the distal end of the medical insertion tool is inserted into the biological tissue for medical purposes, and a detection method thereof. Is.

[0002]

2. Description of the Related Art When inserting an elongated tubular medical insertion tool into a very narrow body tissue tube such as a catheter inserted into a vein, the body tissue may be strayed or caught by friction with the surface of the body tissue. It is extremely important to accurately detect the current direction of the insertion tip of the medical inserter in order to insert the inserter easily and smoothly while checking the target direction without adversely affecting the Is.

Conventionally, as the tip direction detecting means of the medical insertion instrument which plays an important role as described above, conventionally, a means for advancing the insertion work while taking an X-ray image and observing an X-ray contrast image in real time is generally adopted. However, in this case, not only skilled techniques are required, but the human body of the operator and the patient will be adversely affected by the X-ray exposure, and the adverse effects of the X-ray exposure will be avoided. If a protector for X-ray protection is worn for safe and secure work, it is difficult for the operator to do the work, and the operator feels discomfort.

An example of a body cavity position detecting device capable of detecting the position and shape of an insertion tool without performing X-ray imaging that causes such adverse effects on the human body and discomfort is disclosed in, for example, Japanese Patent Laid-Open No. 6-285043. Has been proposed (hereinafter referred to as "prior art"). The detection device according to this prior art includes a magnetic field generation element (magnetic field generation means) having a magnetic field generation coil and a magnetic detection element (magnetic field detection means) having a magnetic reception coil for detecting a magnetic field generated by the magnetic field generation element. At least one is provided along the insertion portion of the medical insertion tool, and one of the magnetic generation element or the magnetic detection element is inserted into the body cavity along with the insertion of the insertion tool, that is, is integrally inserted into the living tissue, In this state, the magnetic field generated from the magnetic field generating element is detected by the magnetic field detecting element to detect the position and shape of the insertion portion.

[0005]

However, in the detection device according to the prior art having the above-described structure, at least one of the magnetic field generating element and the magnetic field detecting element is used as the insertion portion of the medical insertion tool inserted into the living tissue. Because it must be attached,
Not only the size of the medical insertion tool itself, in particular, the diameter of the insertion portion into the living tissue increases, but also the weight of the insertion portion increases. Therefore, although the position detection function in the inserted state can be exerted as prescribed, insertion into a very narrow body tissue tube becomes more difficult than the conventional one, and the body tissue such as a trap due to friction with the body tissue surface is caused. There was a problem that the adverse effects were rather increased.

[0006] The present invention has been made in view of the above circumstances, and is intended to be miniaturized while easily and smoothly inserting into a narrow living tissue and making it possible to significantly reduce the adverse effect on the living tissue. An object of the present invention is to provide a device for detecting the tip direction of a medical insertion tool into a living tissue and a method for detecting the tip direction, which can detect the direction in which the insertion tip is facing reliably and accurately.

[0007]

In order to achieve the above object, the tip direction detecting device for a medical insertion tool into a living tissue according to the present invention is a medical insertion tool itself or a medical insertion tool that can be inserted into a living tissue. A linear insertion member that is attached to an existing medical insertion tool integrally with the medical insertion tool so as to be insertable into a living tissue has flexibility and is made of a magnetic material having high magnetic permeability. A magnetic field generating means is attached to the insertion proximal end portion of the magnetic material-made medical insertion tool or the linear insertion member, and a magnetic field generated by the magnetic field generation means is provided separately from the magnetic field generation means. Among them, magnetic field detecting means for detecting a leakage magnetic field from the insertion tip of the magnetic material medical insertion tool or the linear insertion member to detect the direction in which the tip of the medical insertion tool is facing is provided. It is characterized by.

Further, the method of detecting the distal direction of a medical insertion instrument into a living tissue according to the present invention is a medical insertion instrument itself or an existing medical instrument which is made of a magnetic material having flexibility and high magnetic permeability. In the state where the linear insertion member attached to the medical insertion tool of is inserted into the living tissue, the magnetic field generated by the magnetic field generating device attached to the insertion base end of the linear insertion member is made of a magnetic material. Introduced into the insertion member, by detecting the leakage magnetic field from the insertion tip of the magnetic material-made medical insertion tool or the linear insertion member by the magnetic field detection means arranged outside the biological tissue, the tip of the medical insertion tool It is characterized in that the direction in which it is facing is detected.

According to the present invention having the above-mentioned constitutional requirements, the medical inserter itself to be inserted into the living tissue is made of a magnetic material having a high magnetic permeability, or an existing medical inserter is used. Since it suffices to additionally attach a linear insertion member made of a magnetic material having high magnetic permeability, when at least one of the magnetic generation element and the magnetic detection element is attached to the insertion portion of the medical insertion tool as in the prior art. In comparison, it is possible to reduce the size and weight of the medical insertion tool as a whole.
The insertion work itself into a narrow living tissue can be performed easily and smoothly. In addition, by introducing a magnetic field generated by a magnetic field generator placed outside the living tissue along with the insertion into an insertion tool or linear insertion member made of a magnetic material and detecting a leakage magnetic field from the tip of the insertion tool, the human body is adversely affected. The X-ray is safe from the direction in which the distal end of the medical insertion tool is currently facing, without being exposed to X-rays and without the discomfort of wearing a protective protector to avoid its adverse effects. It is possible to insert the medical insertion tool in a desired direction reliably and easily while confirming it accurately.

As a medical insert in the distal end direction detecting device for a medical insert into living tissue according to the present invention, as described in claim 2, a catheter, an endoscope, or a drainage tube, a biliary stent. , An in-vivo indwelling device including a high-calorie infusion tube or any of those selected from guide wires, but especially inserted into a very narrow body tissue such as a vein. Therefore, it can be most effectively applied to the detection of the distal direction of a catheter, which is highly demanded to be downsized and reduced in diameter.

Further, in the distal end direction detecting device for a medical insertion tool into a living tissue according to the present invention, the height of the linear insertion member attached to the medical insertion tool itself or an existing medical insertion tool is increased. As the magnetic material having magnetic permeability, as described in claim 3, an alloy containing any one or more of iron, nickel, cobalt such as amorphous or permalloy is preferable. Among them, the Fe-Co-Si-B based amorphous alloy has a magnetic permeability μ = B / H (B: magnetic flux density, H:
The strength of the magnetic field is about 15,000, which is extremely high, and it has excellent flexibility and has no effect on the human body. Therefore, it exhibits a reliable leak magnetic field detection function outside the living tissue. Therefore, the minimum diameter required is generally 100 μm or less as compared with the minimum ferrite of about 1000 μm which is usually used as a general magnetic material, which is most preferable as a medical insertion tool. By the way,
The magnetic permeability μ of permalloy, which is an iron-nickel (Fe—Ni) alloy, is about 4000.

Further, in the distal end direction detecting device for a medical insertion tool into a living tissue according to the present invention, the magnetic field detecting means used outside the living tissue may be one or more as described in claim 4. It is preferable to use a magnetic field sensor composed of a plurality of magneto-impedance elements. Besides this,
A handheld type magnetic detector with a built-in Hall element, detection coil, etc. may be used to detect the distal direction of a high-permeability medical insertion tool or linear insertion member from a permanent magnet that is a magnetic generation means. Good thing, of course.

[0013]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is a schematic configuration diagram showing a first embodiment of a distal direction detecting device for a medical insertion tool according to the present invention, and a distal direction detecting device 1 for a medical insertion tool according to the first embodiment.
Is a catheter 2 as an example of a medical insertion tool, in which an insertion portion 3 that can be inserted into a living tissue tube such as a vein is flexible and has a high magnetic permeability, for example, a magnetic permeability μ is 1
It is composed of about 5000 Fe-Co-Si-B based amorphous alloy and has a diameter of about 100 μm.

A permanent magnet 5 as a magnetic field generating means for generating a magnetic field is fixedly attached to a proximal end portion of the insertion portion 3 made of a magnetic material having a high magnetic permeability in the operation portion 4 of the catheter 2. The magnetic field generated by the permanent magnet 5 is introduced into the magnetic material insertion portion 3. On the other hand, a magnetic impedance element as a magnetic field detecting means for detecting a leakage magnetic field from the insertion tip portion 3a of the magnetic material insertion portion 3 inserted into the living tissue tube and into which the magnetic field generated by the permanent magnet 5 is introduced outside the living tissue. A magnetic field sensor 6 consisting of is provided separately from the catheter 2.

In the distal end direction detecting device 1 for a catheter insertion part according to the first embodiment having the above-mentioned structure, when the insertion part 3 of the catheter 2 is inserted into a living tissue tube such as a vein,
A magnetic field generated by a permanent magnet 5 attached to the operating portion 4 of the catheter 2 is introduced into the insertion portion 3, and the introduced magnetic field constantly leaks from the insertion tip portion 3a. The position of this leakage magnetic field moves as the insertion of the insertion portion 3 progresses, and the tip of the insertion portion 3 of the catheter 2 is detected by detecting the leakage magnetic field that moves in this position with the magnetic field sensor 6 arranged outside the living tissue. It is possible to detect the current direction.

As described above, the insertion portion 3 of the catheter 2 can be operated without any discomfort due to the work while wearing the protective protector for avoiding adverse effects on the human body due to radiography and exposure to X-rays. It is possible to achieve the predetermined medical purpose by surely and easily inserting the insertion portion 3 in the intended direction while safely and accurately confirming the direction in which the distal end is currently facing.

2 and 3 are a schematic block diagram showing a second embodiment of the distal end direction detecting device for a medical insertion tool according to the present invention and an enlarged cross-sectional view of the main part. The distal end direction detection device 11 for a medical insertion tool of the second embodiment is an insertion portion 13 that can be inserted into a living tissue tube such as a vein of an existing catheter 12 having a diameter of 100 μm or more and less than 1 mm as an example of the medical insertion tool. A linear insertion member 15 made of an Fe-Co-Si-B based amorphous alloy having a magnetic permeability μ of about 15,000 and having a diameter of about 30 μm is arranged along the side surface over the entire length of The entire circumference of the insertion portion 13 including the linear insertion member 15 is covered with the silicon film 16.

The structure other than the above is the same as that of the first embodiment. That is, in the operation portion 14 of the existing catheter 12, a permanent magnet 5 as a magnetic field generating means for generating a magnetic field is fixedly attached to the proximal end portion of the magnetic material linear insertion portion 13 of the high magnetic permeability. This permanent magnet 5
The magnetic field generated by is introduced into the magnetic material linear insertion member 13. On the other hand, the magnetic field detecting means for detecting the leakage magnetic field from the insertion tip portion 13a of the magnetic material linear insertion portion 13 into which the magnetic field generated by the permanent magnet 5 is inserted into the living tissue tube outside the living tissue. A magnetic field sensor 6 composed of an impedance element is provided separately from the catheter 12.

In the tip direction detecting device 11 for the catheter insertion portion according to the second embodiment having the above-mentioned structure, the catheter 1
When inserting the second insertion portion 13 into a living tissue tube such as a vein, the operating portion 14 of the catheter 12 is attached to the linear insertion member 15 provided along the entire length of the side surface portion of the insertion portion 13.
A magnetic field generated by a permanent magnet 5 attached inside is introduced, and the introduced magnetic field is applied to the catheter 12
Linear insertion member 13 at the same position as the tip of the insertion portion 13 of
Is constantly leaking from the insertion tip portion 3a. The position of this leakage magnetic field moves as the insertion of the insertion portion 13 progresses, but by detecting the leakage magnetic field that moves in this position by the magnetic field sensor 6 arranged outside the biological tissue, the adverse effect on the human body due to radiography and the X-ray image are detected. While safely and accurately confirming the direction in which the distal end of the insertion portion 13 of the catheter 12 is currently facing, without any discomfort caused by work while wearing a protective protector for avoiding radiation exposure, It is possible to insert the insertion portion 13 in a desired direction reliably and easily to achieve a predetermined medical purpose.

Although the first and second embodiments have been described as being applied to catheters as medical inserts, they may be applied to endoscopes other than catheters.
Furthermore, for detecting the distal direction of indwelling devices such as drainer tubes (ERBD tubes), bile duct stents, high calorie infusion tubes, probes for hyperthermia treatment in living tissues and their guide wires, which form drainage channels for body fluids. Is also applicable.

As the magnetic field generating means, instead of using the permanent magnet shown in each of the above-mentioned embodiments, an electromagnetic coil may be used and a pulse current is passed through it to generate a magnetic field. In this case, as the magnetic field detecting means, it is also possible to use a current detecting section for detecting the induced current generated by the leakage magnetic field.

Further, as the magnetic field detecting means, in the above embodiments, the magnetic field sensor 6 comprising a magnetic impedance element is used.
However, by using a plurality of magnetic field sensors, it is possible to realize three-dimensional detection in the direction in which the distal end of the medical insertion tool such as a catheter is facing.

[0023]

As described above, according to the present invention, the medical inserter itself to be inserted into the living tissue is made of a magnetic material having a high magnetic permeability, or the existing medical inserter has a high magnetic permeability. Just by adding a linear insertion member made of magnetic material with permeability,
Since it is possible to accurately detect the direction in which the distal end of the medical insertion tool is currently facing without performing radiography that causes adverse effects on the human body and discomfort to the work itself, compared to the case of the prior art. As a result, the overall size and weight of the medical insertion tool can be reduced, which makes it easier and smoother to insert the body into a narrow body tissue, and to further reduce the adverse effects on the human body during insertion. In spite of this, it is possible to reliably, safely and easily insert the medical insertion tool in the intended direction while accurately confirming the current direction of the distal end of the medical insertion tool.

[Brief description of drawings]

FIG. 1 is a schematic configuration diagram showing a first embodiment of a distal end direction detection device for a medical insertion tool according to the present invention.

FIG. 2 is a schematic configuration diagram showing a second embodiment of the distal end direction detection device for a medical insertion tool according to the present invention.

3 is an enlarged cross-sectional view of a main part taken along line XX of FIG.

[Explanation of symbols]

1,11 Medical tip insertion end detector 2,12 catheter (an example of medical insert) 3,13 insertion part 3a, 13a Insertion tip 5 Permanent magnet (an example of magnetic field generating means) 6 Magnetic sensor (an example of magnetic field detection means) 15 Linear insertion member

Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) A61M 25/00 312 A61M 25/00 312 25/01 450Z F term (reference) 4C061 AA00 BB00 CC00 DD03 FF11 FF21 FF50 HH51 JJ01 JJ17 4C077 AA26 CC02 EE04 FF04 HH10 HH20 4C081 AC07 AC08 BC02 CG04 CG08 DA03 4C167 AA01 AA28 AA32 AA39 AA41 AA56 AA77 BB02 BB44 BB63 CC07 CC08 CC22 EE01 EE20 GG22 GG23 H11H30H08

Claims (5)

[Claims] 1. A linear insertion member that is attached to a medical inserter itself that can be inserted into a living tissue or an existing medical inserter so as to be integrally inserted with the medical inserter into a biological tissue. Has flexibility and is composed of a magnetic material with high magnetic permeability, and a magnetic field generating means is attached to the insertion base end portion of the magnetic material-made medical insertion tool or linear insertion member. Separately from the insertion tool with magnetic field generating means, a magnetic field generated by the magnetic field generating means is used to detect a leakage magnetic field from the insertion tip of the magnetic material-made medical insertion tool or the linear insertion member to detect the medical insertion tool. A tip direction detection device for a medical insertion tool into a living tissue, comprising magnetic field detection means for detecting the direction in which the tip is facing. 2. The medical insert is selected from an in-vivo indwelling device including a catheter, an endoscope or a drainage tube, a biliary stent, a high-calorie infusion tube, or a guide wire thereof. 1. The tip direction detection device for a medical insertion tool into the living tissue according to 1. 3. The amorphous or alloy containing at least one of iron, nickel, and cobalt is used as the magnetic material having a high magnetic permeability.
The device for detecting the tip direction of the medical insertion tool into the living tissue according to [4]. 4. The distal end direction detecting device for a medical insertion tool into a living tissue according to claim 1, wherein the magnetic field detecting means is a magnetic field sensor including one or a plurality of magnetic impedance elements. . 5. A medical insertion tool itself, which is made of a magnetic material having flexibility and high magnetic permeability, or a linear insertion member attached to an existing medical insertion tool is inserted into a living tissue. In this state, the magnetic field generated by the magnetic field generator attached to the insertion base end is introduced into the magnetic material-made medical insertion tool or linear insertion member, and the magnetic material-made medical insertion tool or linear insertion member By detecting the leakage magnetic field from the insertion tip by the magnetic field detection means arranged outside the living tissue,
A method for detecting the direction of the distal end of a medical insertion tool into living tissue, which comprises detecting the direction in which the distal end of the medical insertion tool is facing.