WO2016194913A1

WO2016194913A1 - Catheter

Info

Publication number: WO2016194913A1
Application number: PCT/JP2016/066062
Authority: WO
Inventors: 荒井　恒憲; 恵美子渡部; 恵美悠小川
Original assignee: 株式会社アライ・メッドフォトン研究所
Priority date: 2015-06-01
Filing date: 2016-05-31
Publication date: 2016-12-08
Also published as: JPWO2016194913A1

Abstract

The objective of the present invention is to provide a catheter equipped with a compact lasso-type distal end portion capable of being easily disposed in tissue to be treated. This catheter is provided with a distal end portion having at least one inner bore, wherein the distal end portion is provided with a base portion which extends from a proximal side of the catheter to a distal side thereof, and a loop-shaped portion having a spiral shape which is a continuation of and extends from the distal side end portion of the base portion. The base portion is provided, at least, with: a rising portion which is adjacent to the loop-shaped portion and rises from the loop-shaped portion at an angle relative to a plane formed by the loop-shaped portion; an extension portion which extends from the rising portion; and a shaft portion which bends from the extension portion and is at an angle relative to the plane and the rising portion. The shaft portion is disposed in a region that overlaps or is surrounded by the loop-shaped portion when viewed in the axial direction of the spiral shape, in a position opposing the proximal side end portion of the loop-shaped portion in the direction of said plane.

Description

catheter

The present invention relates to a catheter having a tip formed in a loop shape.

A catheter with a loop-shaped tip is generally used as an electrode catheter used for cardiac electrophysiology in the diagnosis or treatment of cardiac arrhythmia, and as an ablation catheter used for insulation (isolation, isolation, blockage) of the pulmonary vein sinus (For example, Patent Document 1).

A catheter having a distal end formed in a loop shape typified by Patent Document 1 is also called a lasso catheter. For example, a catheter 700 shown in FIG. 12 is known.
A conventional catheter 700 shown in FIG. 12 is arranged outside a patient's body and is operated by a doctor and is not shown, a long lumen catheter shaft 740 connected to the distal side of the operation handle, and a catheter shaft 740 includes a head portion 710 that is connected to the distal end of 740 with an adhesive and is composed of a tubular body of flexible material. The head portion 710 includes a loop-shaped portion 720 having a spiral shape for more than one turn, a bent portion 733 bent at the end of the loop-shaped portion, and a connection extending substantially linearly from the bent portion 733 toward the catheter shaft 740. Part 734.

The shape shown in FIG. 12 is maintained when the head part 710 is not receiving external force by the shape memory material inserted inside.
As shown in FIG. 12, the loop-shaped portion 720 has a spiral shape of more than one round. Therefore, in the state where the external force pressing the loop-shaped portion 720 in the axial direction of the loop shape is received, the distal tip is the proximal side In contact with the bent portion 733 to form a closed ring shape. Accordingly, the entire circumference of the inner wall of the pulmonary sinus can be opposed, and when used as an ablation catheter, an electrical signal transmitted through the pulmonary sinus can be blocked and insulated.

However, in the conventional catheter of FIG. 12, the bent portion 733 on the proximal side of the loop portion 720 is located near the distal end of the loop portion 720, and the connection portion 734 is a loop of the loop portion 720. It extends toward the axial direction of the shape. That is, when the head portion 710 is viewed from the distal side toward the axial direction of the loop shape, the connection portion 734 overlaps the loop shape of the loop shape portion 720 and extends from the loop shape portion 720 to the proximal side. .
Accordingly, as shown in FIG. 13A, in the conventional catheter of FIG. 12 in which the loop-shaped portion 720 is bent at a substantially right angle with respect to the connection portion 734, the loop-shaped portion 720 is applied to the target tissue W to be diagnosed or treated. When the contact portion 734 makes an angle ε between the connection portion 734 and the target tissue W being an obtuse angle, the loop-shaped portion 720 floats away from the target tissue W.

As shown in FIG. 13B, the entire circumference of the loop-shaped portion 720 can be brought into contact with the target tissue W if the angle ε formed with the connection portion 734 can be turned in an acute angle direction. However, the head unit 710 is operated by a doctor far away from the patient's body with an operation handle (not shown) at hand. The head portion 710 is not always advanced so that the angle ε formed by the portion on the 720 side becomes an acute angle. Once the head unit 710 reaches the target tissue W in the arrangement shown in FIG. 13A, etc., which is different from the desired arrangement shown in FIG. 13B, the doctor moves the head with an operation handle (not shown) at hand. The position and orientation of the portion 710 must be changed so that the entire loop-shaped portion 720 contacts the target tissue W as shown in FIG. 13B, and the limited procedure time can be reduced. For that.
The conventional catheter of FIG. 12 is not flexible in movement, and sufficient operability has not been obtained in the heart lumen.

In view of this, a catheter has been proposed in which the loop-shaped portion at the distal end is configured to have a loop shape with more than two rounds so that the loop-shaped portion is easily opposed to the target tissue (for example, Patent Document 2).
In the catheter of Patent Document 2, the tip portion is formed in a spiral shape with the proximal side on the inside and the distal end portion on the outside, and wound more than twice on substantially the same plane.
According to the catheter of Patent Document 2, since it has a spiral shape with more than two rounds, the distal end portion is pushed into the blood vessel inlet so that the proximal side constituting the small diameter loop enters the back side of the small diameter, Since the distal side with the larger diameter faces the base side and the proximal side with the smaller diameter faces the portion with the smaller diameter on the back side than the blood vessel inlet, the result is a loop shape at the tip over the entire circumference of the target tissue. The parts can be made to face each other.

JP2013-202241A JP 2014-128675 A

However, in the invention of Patent Document 2, the operation of making the tip portion face the target tissue can be simplified, but the catheter tip portion has been enlarged. In diagnosing or treating cardiac arrhythmia, the catheter is advanced to the heart through a guide sheath that is inserted from the elbow (brachial artery), wrist (radial artery), and lower limb (femoral artery) arteries to the heart. In order to ensure the operability of inserting the catheter into the inside, it is desirable that the tip portion be small.
Further, even when the distal end portion is installed in the target tissue, a large space is taken because the distal end portion of the catheter is large.

The present invention has been made in view of the above-described problems, and an object of the present invention is to provide a catheter having a small lasso-type tip that can be easily placed in a tissue to be treated.

The subject is, according to the present invention, a catheter having a tube-shaped tip, the tip extending from the proximal side of the catheter to the distal side, and the distal side of the base. A spiral loop extending continuously from the end, and the base is adjacent to the loop and has a first angle with respect to a surface formed by the loop. A rising portion that rises from a loop-shaped portion; and a shaft portion that is bent with respect to the rising portion and has a second angle that is greater than the first angle with respect to the surface; This is solved by being arranged at a position facing the proximal end of the loop-shaped part.

Since it is configured in this manner, the rising portion that rises from the loop-shaped portion at a first angle, and the second portion that is bent with respect to the rising portion and is larger than the first angle with respect to the surface of the loop-shaped portion. The base portion including the shaft portion having an angle exhibits elasticity, and the loop-shaped portion is easily brought into contact with various shapes of tissues and lumens in the living body. Therefore, unlike the tip of a conventional catheter, a part of the loop-shaped portion does not float from the tissue or lumen regardless of the angle of contact with the tissue or lumen. It is possible to easily and quickly perform the operation of installing the catheter tip.
In addition, since the shaft portion of the base portion is disposed at a position facing the proximal end portion of the loop-shaped portion, the portion adjacent to the proximal-side end portion of the loop-shaped portion, which is one end of the base portion, and the base portion The shaft portion of the base portion which is the end is disposed at a position facing each other, and sufficient elasticity can be given to the base portion.

The base portion includes an extension portion extending between the rising portion and the shaft portion, and the shaft portion overlaps with or is surrounded by the loop-shaped portion when viewed from the axial direction of the spiral shape. It may be arranged.
Since the base includes an extension between the rising portion and the shaft with an angle within a range from the first angle to the second angle with respect to the surface, the extension exhibits elasticity. Thus, the loop-shaped portion is easily brought into contact with various shapes of tissues and lumens in the living body.
Since the shaft portion is disposed in a region overlapping or surrounded by the loop-shaped portion when viewed from the spiral axial direction, the base portion is within the region formed by the loop-shaped portion, and the tip portion Is not enlarged. Therefore, in order to improve the operability of installing the loop-shaped portion in the tissue, the distal end portion of the catheter does not need to have a large shape, and can be configured as a small device having a small catheter distal end portion. As a result, it is possible to achieve a catheter that is easy to operate by setting the catheter tip to the treatment target tissue without impairing the operability of the operation of passing the catheter tip through the blood vessel in advance to advance the catheter tip to the treatment target tissue. it can.
The surface formed by the loop-shaped portion may be substantially flat.
Due to such a configuration, it becomes possible to block an electric signal by measuring the inner wall of the pulmonary sinus and to measure the electric signal.

The shaft portion may be disposed at a position facing the proximal end portion of the loop-shaped portion in a direction that can be substantially identical to the radial direction of the spiral shape.
Since it is configured in this way, the elasticity of the base can be achieved by the rising and extending parts that are short and do not protrude from the range of the loop-shaped part, so that the tip part is not enlarged. The elasticity when the loop-shaped part is pressed against the tissue to be treated can be increased efficiently.

The rising portion and the extension portion may overlap the loop-shaped portion when viewed from the axial direction of the spiral shape.
Since it is configured in this way, the elasticity of the base can be achieved by the rising and extending parts that are short and do not protrude from the range of the loop-shaped part, so that the tip part is not enlarged. The elasticity when the loop-shaped part is pressed against the tissue to be treated can be increased efficiently.

The rising portion and the extension portion may pass through a region surrounded by the loop-shaped portion when viewed from the axial direction of the spiral shape.
Since it is configured in this way, the elasticity of the base can be achieved by the rising and extending parts that are short and do not protrude from the range of the loop-shaped part, so that the tip part is not enlarged. The elasticity when the loop-shaped part is pressed against the tissue to be treated can be increased efficiently.

The rising portion and the extension portion may be curved in the same direction as the distal portion of the loop-shaped portion.
Since it comprises in this way, a front-end | tip part can be comprised as a natural curve, and the workability of a front-end | tip part improves.
The rising portion and the extension portion may include a portion that is substantially straight when viewed from the axial direction of the spiral shape.

The surface of the loop-shaped portion on the outer periphery side of the spiral shape may include a rough surface that can be locked to a living tissue in the vicinity of the distal end portion of the loop-shaped portion.
With this configuration, the loop-shaped part is multiplexed by rotating the shaft part in either direction with the rough surface near the distal end of the loop-shaped part locked to the living tissue. These can be made into a spiral shape with a small outer periphery, or conversely, can be made into a large circle, and can be applied to lumens of various diameters and shapes.

According to the present invention, the rising portion rising from the loop-shaped portion at a first angle, the extending portion extending from the rising portion, the bending from the extending portion, and the surface of the loop-shaped portion from the first angle. The base portion including the shaft portion having a large second angle exhibits elasticity, and the loop-shaped portion is easily brought into contact with various shapes of tissues and lumens in the living body. Therefore, unlike the tip of a conventional catheter, a part of the loop-shaped portion does not float from the tissue or lumen regardless of the angle of contact with the tissue or lumen. It is possible to easily and quickly perform the operation of installing the catheter tip.

Further, the shaft portion of the base portion is disposed in a region that overlaps or is surrounded by the loop-like portion when viewed from the axial direction of the spiral shape, and that is opposed to the proximal end portion of the loop-like portion. For this reason, the base portion is within the region formed by the loop-shaped portion, and the tip portion is not enlarged. Therefore, in order to improve the operability of installing the loop-shaped portion in the tissue, the distal end portion of the catheter does not need to have a large shape, and can be configured as a small device having a small catheter distal end portion. As a result, it is possible to achieve a catheter that is easy to operate by setting the catheter tip to the treatment target tissue without impairing the operability of the operation of passing the catheter tip through the blood vessel in advance to advance the catheter tip to the treatment target tissue. it can.

BRIEF DESCRIPTION OF THE DRAWINGS It is an external view of the laser catheter which concerns on Embodiment 1 of this invention, Comprising: (A) is the top view seen from the distal side of a head part, (B) is a B arrow view of FIG. 1 (A). (C) is a C arrow view of FIG. 1 (A). 1 is a perspective view of a laser catheter according to Embodiment 1 of the present invention. (A) (B) is explanatory drawing of the state which applied the laser catheter which concerns on Embodiment 1 of this invention to the lumen | bore of the treatment object tissue. It is an external view of the electrode catheter which concerns on Embodiment 2 of this invention, Comprising: (A) is the top view seen from the distal side of a head part, (B) is a D arrow line view of FIG. 4 (A). (C) is a F arrow view of FIG. 4 (A). It is an external view of the catheter which concerns on Embodiment 3 of this invention, Comprising: (A) is the top view seen from the distal side of the head part, (B) is F arrow directional view of FIG. 5 (A). is there. It is an external view of the catheter which concerns on Embodiment 4 of this invention, Comprising: (A) is the top view seen from the distal side of the head part, (B) is a G arrow directional view of FIG. 6 (A). is there. It is a perspective view of the catheter which concerns on Embodiment 4 of this invention. It is the top view which looked at the modification of the catheter which concerns on Embodiment 4 of this invention from the distal side of the head part. It is the external view of the catheter which concerns on Embodiment 5 of this invention, Comprising: (A) is the top view seen from the distal side of the head part, (B) is a H arrow view of FIG. 9 (A). is there. It is explanatory drawing which shows the state which applied the catheter which concerns on Embodiment 5 of this invention in the lumen | bore. It is explanatory drawing which shows the state which applied the catheter which concerns on Embodiment 5 of this invention in the lumen | bore. It is a perspective view which shows the conventional catheter. It is explanatory drawing which shows the state which applied the conventional catheter to the treatment target tissue.

Hereinafter, embodiments of the catheter of the present invention will be described with reference to FIGS.
In each embodiment, a catheter will be described. However, the present invention includes a sheath, an endoscope, a venous conduit, an arterial conduit, a bronchoscope, a cystoscope, a culpascope, a colonoscope, a trocar, a laparoscope, It can also be applied to medical devices such as other medical tubes that are introduced to a tissue to be treated in a living body.
The catheter of the present invention can be used as a laser catheter for photodynamic therapy. Specifically, in addition to laser catheters for treating arrhythmias that create abnormal electrical conduction cutoff lines, biliary endoscopes (outer diameter 1 to 3 mm), pancreatic endoscopes (outer diameter 1 to 2.5 mm), etc. It can be used as a laser catheter for endoscopic photodynamic therapy for cancer in the pancreas and biliary tract using an ultrafine endoscope.

When the catheter of the present invention is used as an ablation catheter for arrhythmia treatment that insulates the pulmonary venous sinus and creates an abnormal electric conduction cutoff line, it is used for ablation by heating, for example, a high frequency ablation catheter, ultrasonic wave or laser energy It can be applied as a catheter using a catheter, a cryoablation catheter or the like.
When the catheter of the present invention is used for a medical device equipped with a light emitting probe such as a laser catheter, it is used for photodynamic treatment such as cancer, infection, arteriosclerosis, treatment of thrombosis using a laser catheter, etc. Applicable. Further, it can be used in all cases where laser irradiation and laser measurement are performed.
The catheter of the present invention can also be used as an electrode catheter used for diagnosis of abnormal electrical conduction. It is also possible to configure an ablation catheter as a catheter that performs both diagnosis and treatment of abnormal electrical conduction by arranging electrodes.

In this specification, the proximal means the outside of the living body, that is, the operator side in a state where the laser catheter 1 is inserted into the living body, and the distal means the distal end side of the portion inserted into the living body, Refers to the tissue side to be treated or diagnosed.
The loop-shaped

portions

20, 120, 320, 420, and 720 of the laser catheter 1 and the

catheters

201, 301, 301 ′, 401, and 700 according to the following embodiments are the distal ends in FIGS. Although shown clockwise or counterclockwise when viewed from the side, it is possible to configure either clockwise or counterclockwise.

<Embodiment 1 Laser catheter 1>
The laser catheter 1 of this embodiment is an extracellular photodynamic therapy (Extra-cellular PDT) in which a sufficient amount of a photosensitive substance (hereinafter referred to as a PDT drug) is distributed in extracellular stroma and blood vessels in a tissue to be treated. For use in connection with a photodynamic therapy device (not shown). The treatment device (not shown) projects the light dynamic therapy by irradiating the irradiation light diffuser of the laser catheter 1 with the light dynamic therapy, and simultaneously receives the return fluorescence from the monitor light diffuser. Thus, the index value of the information related to the treatment progress is calculated in real time during the treatment and displayed on the screen. The practitioner can estimate the degree of injury of the tissue to be treated by light irradiation from time to time while looking at the index value of the information related to the treatment progress displayed on the screen in real time during the treatment. .

In the present embodiment, the laser catheter 1 is used for the treatment of arrhythmia, but it may be any extracellular photodynamic treatment that is performed by distributing a sufficient amount of the PDT drug in the extracellular stroma and blood vessels in the tissue to be treated. It can also be used for other treatments such as photodynamic treatment for infectious diseases. Even if it is cancer treatment (including gastroenterology, respiratory medicine, brain surgery, dermatology), treatment of arteriosclerosis, etc. where PDT drugs accumulate in the cells of the tissue to be treated As long as a sufficient amount of PDT drug and oxygen are continuously supplied into the blood vessel and the blood vessel, they can be used. It may also be used for angioplasty.

The arrhythmia treated using the laser catheter 1 is tachyarrhythmia, particularly an arrhythmia caused by the presence of an abnormal electric conduction site or an abnormal excitement generation site. Conventionally, radiofrequency ablation treatment is performed. Includes all tachyarrhythmias that have occurred. Specifically, atrial fibrillation (AF) including paroxysmal AF, persistent atrial fibrillation (persistent AF), permanent atrial fibrillation (permanent AF), and atrial flutter (AFL: atrial flutter), atrioventricular reciprocating tachycardia (AVRT), atrioventricular nodal reentrant tachycardia (AVNRT), atrial tachycardia (AT) Can be used for including paroxysmal supraventricular tachycardia.
Infectious diseases include MRSA infection, gingivitis, periodontitis, peri-implantitis, herpes, stomatitis, candiditis and the like.

A laser catheter 1 shown in FIGS. 1 and 2 is detachably connected to a distal end of a tube (not shown) connected to the treatment apparatus by a connector (not shown).
As shown in FIGS. 1 and 2, the laser catheter 1 includes a head portion 10 provided at the distal end of the laser catheter 1 and a length provided on the proximal side of the head portion 10 connected to the head portion 10. An operation handle (not shown) operated by a doctor is connected to the proximal side of the catheter shaft 40 opposite to the head portion 10.

As shown in FIGS. 1 and 2, the head portion 10 of the laser catheter 1 of the present embodiment includes a known shape memory wire (not shown) inside a known transparent tube formed from a hollow flexible transparent material. A loop-shaped portion having a spiral shape corresponding to approximately one turn or more than one turn is constituted by a shape memory wire (not shown) that is inserted. The shape of the head portion 10 of the laser catheter 1 is also called a lasso shape, and is not strictly a closed ring shape, but is a pseudo ring shape, so it is also called a ring shape, a ring shape, or a loop shape.
Further, “substantially one round” refers to a shape that has a substantially annular shape close to one round, and that forms a spiral shape for one round when it is brought into contact with the lumen wall of the tissue to be treated and reduced in diameter. . In a state where no external force is applied, it includes a case where it does not exceed one turn and a case where it does exceed one turn but does not exceed two turns.

The head portion 10 includes a base 30 whose end is connected to the distal end of the catheter shaft 40 by an adhesive or welding, and a loop-shaped portion 20 that is continuously provided on the distal side of the base 30. Formed.
Inside the loop-shaped portion 20, a contraction wire (not shown) for reducing the diameter of the spiral shape of the loop-shaped portion 20 by reducing the diameter along the length direction is provided along the entire length of the loop-shaped portion 20. It is inserted. The distal end of the contraction wire is fixed to the distal end 21 of the loop-shaped portion 20, the proximal side passes through the catheter shaft 40, and the proximal end is an operation handle (not shown). It is fixed so that it can be pulled by the operation handle.

By pulling or rewinding the contraction wire (not shown) with an operation handle (not shown), the diameter of the spiral shape of the loop-shaped portion 20 can be adjusted.
The loop-shaped portion 20 is formed in a loop shape from the distal end portion 21 to the proximal end portion 23 in a loop shape for substantially one turn or more than one turn in a state where no external force is received. The distal end portion 21 and the proximal end portion 23 may have a loop shape in contact with each other or a spiral shape apart from each other in a state where no external force is applied, but at least the loop shape portion 20. However, when the diameter of the desired tissue to be treated is reduced and brought into contact, the distal end 21 and the proximal end 23 approach each other to form a closed annular shape.

In the example of FIGS. 1 and 2, the distal end 21 is located inside the proximal end 23 in the loop shape, but the proximal end 23 is located inward of the distal end 21. You may form so that it may be located. Further, when viewed from the distal side along the axial direction of the loop-shaped portion 20 in the direction P in FIG. 2, the loop-shaped portion 21 and the proximal-side end portion 23 are seen to overlap each other. 20 may be formed in a coil shape for more than one turn.
The loop-shaped portion 20 includes an irradiation light diffuser that irradiates excitation light, and a monitor light diffuser that receives the fluorescence emitted from the PDT agent irradiated with the excitation light and the excitation light returned from the laser catheter 1. The light diffuser 29 and a known reflecting plate (not shown) are inserted along the length direction. The loop-shaped portion 20 has a function as an energy radiating portion that irradiates laser light that is energy for treatment or diagnosis.

A base 30 extends proximally from the proximal end 23 of the loop-shaped portion 20.
The base portion 30 is continuous with the proximal end portion 23 of the loop-shaped portion 20, and has a rising portion 31 that is erected with an angle from the proximal end portion 23, and an extension portion 32 that extends continuously from the rising portion 31. And a bent portion 33 which is continuous from the extension portion 32 and extends in the extension direction of the catheter shaft 40 extending in the axial direction of the loop-shaped portion 20 and a connection portion 34 connected to the catheter shaft 40 are integrally formed. . The connecting portion 34 may be configured to be as short as possible, and may not include the connecting portion 34.
The bent portion 33, the connecting portion 34, and / or the distal end portion of the catheter shaft 40 of the present embodiment corresponds to the shaft portion.

The rising portion 31 is bent at an obtuse angle from the loop-shaped portion 20, so that an angle α (first angle) of about 5 to 70 °, preferably about 15 to 60 ° from the surface P 1 formed by the loop-shaped portion 20. Hold and bend to stand up proximally.
The extension portion 32 has a loop-shaped portion when viewed from the P direction in FIG. 2 so that the angle with the surface P1 formed by the loop-shaped portion 20 is smaller than the angle α formed by the surface P1 and the rising portion 31. It extends in the proximal direction away from the loop-shaped portion 20 while drawing an arc shape overlapping the 20 curved shape. In addition, although the extension part 32 of this embodiment has drawn the arc shape which overlaps with the curved shape of the loop-shaped part 20 when it sees from the P direction of FIG. 2, when it sees from the P direction of FIG. You may extend in the diameter direction of the circle which the part 20 draws, or the chord direction which does not pass through the center of a circle.

In the present embodiment, the extension portion 32 is also inclined by less than 5 ° with respect to the surface P1 in the direction away from the loop-shaped portion 20, but the extension portion 32 may be formed parallel to the surface P1. It may be the same as the angle α formed by the surface P1 and the rising portion 31 or larger than the angle α (first angle) formed by the surface P1 and the rising portion 31, and the surface P1 and the connecting portion 34 form. You may incline at an angle smaller than an angle (2nd angle).
Further, the angle formed between the extension portion 32 and the surface P1 does not have to be the same at all the portions of the extension portion 32, and the angle between the surface P1 gradually increases as the bent portion 33 is approached. Also good.
The bent portion 33 is continuous from the extended portion 32 and is bent so as to be connected to the connecting portion 34 that is substantially perpendicular to the surface P1. The proximal end portion of the connecting portion 34 is connected to the distal end portion of the catheter shaft 40 by an adhesive or welding.

The bent portion 33 to the connecting portion 34 and the catheter shaft 40 are arranged substantially perpendicular (second angle) to the plane P1, and as shown in FIG. 1 (B), viewed in the P direction in FIG. At a point on the circumference opposite to the radial direction formed by the loop-shaped portion 20, that is, a position overlapping with a point moved 180 ° along the circumference about the center E of the circle. Yes. The bent portion 33 and the connecting portion 34 may be arranged in the vicinity of a position overlapping with a point on the opposite side in the radial direction on the circumference formed by the loop-shaped portion 20 when viewed in the P direction of FIG. When viewed in the direction P in FIG. 2, the center E of the circle formed by the loop-shaped portion 20 is set to be approximately 180 ° along the circumference, that is, 160 to 200 °, preferably 175 to 185. It may be arranged at a position overlapping with the point moved by about °.

2 is not limited to a position overlapping with the circumference formed by the loop-shaped portion 20 when viewed in the P direction in FIG. 2, but is a circle formed by the loop-shaped portion 20 when viewed in the P direction in FIG. 2. You may arrange | position in the area | region enclosed.
A portion from the rising portion 31 to the connecting portion 34 and the distal end of the catheter shaft 40 through the extension portion 32 and the bending portion 33 is formed by the loop-shaped portion 20 when viewed in the P direction of FIG. If the head portion 10 is disposed in a position overlapping with the circumference or in a region surrounded by a circle formed by the loop-shaped portion 20 when viewed in the P direction in FIG. 2, the head portion 10 is treated through a blood vessel such as an artery. The operability to advance to the target organization is improved.

A portion from the rising portion 31 through the extension portion 32 and the bending portion 33 to the connection portion 34 and the distal end of the catheter shaft 40 is inserted into a treatment target living body by a contraction wire (not shown). 2, when viewed in the direction P in FIG. 2, the position overlaps with the circumference formed by the loop-shaped portion 20, or the region surrounded by the circle formed by the loop-shaped portion 20. What is necessary is just to have protruded outside the area | region enclosed by the circle | round | yen formed by the loop-shaped part 20 when it sees in the P direction of 2 when the external force is not received.

The base portion 30 of the present embodiment has an arc shape that overlaps the curved shape of the loop-shaped portion 20 when viewed from the P direction of FIG.
In the laser catheter 1 of the present embodiment, the head portion 10 further moves while the loop-like portion 20 goes around in a plane from the distal end portion 21 to the proximal end portion 23 and then descends to the proximal side. A base portion 30 is formed around a half turn, and a catheter shaft 40 serving as a shaft portion is provided at an end portion thereof. As described above, since the extended portion 32 of the base portion 30 has a length and rises obliquely away from the surface P1 formed by the loop-shaped portion 20, the base portion 30 exhibits elasticity. The loop-like part 20 can be brought into contact with the entire circumference of a desired lumen wall to be treated by serving as a spring.

The head portion 10 has a shape indicated by a dotted line in FIGS. 3A and 3B in a state where an external force is not applied. When the head portion 10 is pressed against the lumen wall of the tissue to be treated, the pressing force causes The base 30 is shrunk, and the loop-shaped part 20 is pushed down to the position of the solid line in FIGS. 3 (A) and 3 (B). Therefore, no matter which side the catheter shaft 40 is inclined with respect to the lumen wall to be treated, a part of the loop-shaped portion 20 does not float from the tissue to be treated and is not separated.
Therefore, unlike the conventional catheter shown in FIG. 13, the position where the head unit 10 contacts first is not selected, and high skill is not required to arrange the head unit 10. In a cardiac catheter procedure that must be performed in a short time, the time required for placement of the catheter can be shortened.
In the laser catheter 1 of FIG. 2, the loop-shaped portion 20 is wound clockwise from the distal end 21 to the proximal end 23 when viewed from the P direction from the distal side. However, it is not limited to this, and may be wound counterclockwise.

<Embodiment 2 electrode catheter 101>
FIG. 4 shows the head portion 110 of the electrode catheter 101 according to the second embodiment.
The present embodiment is an example in which the shape of the head unit 10 of the first embodiment is applied to the head unit 110 of the electrode catheter 101.
The loop-shaped portion 120 in FIG. 4 is formed by inserting a known shape memory wire (not shown) and a lead wire (not shown) into a known tube formed from a hollow flexible material.
As shown in FIG. 4, a plurality of ring-shaped electrodes 129 </ b> R and one tip electrode 129 </ b> T are provided on the outer periphery of the loop-shaped portion 120, and loop-shaped through the side holes (not shown) provided in the loop-shaped portion 120. It is connected to a lead wire (not shown) inserted through the portion 120.
A lead wire (not shown) is connected to a potential detection device (not shown) via a connector (not shown). Thereby, potential signals derived from the ring-shaped electrode 129R and the distal electrode 129T are input to a potential detection device (not shown), and information on the contact state of the ring-shaped electrode 129R and the distal electrode 129T with the tissue to be treated, etc. Is calculated by a known method.

Other configurations of the electrode catheter 101 of FIG. 4 are the same as those of the catheter 1 of FIGS. 1 and 2 except that the electrode catheter 101 of FIG. 4 does not include the light diffuser 29 and a known reflector (not shown). Since it is the same as that of FIG.
According to the electrode catheter 101 of FIG. 4, the loop-shaped portion 120 can be easily brought into contact with the lumen wall of the tissue to be treated in measuring the intracardiac potential, electrical stimulation of the myocardium, or the like. Due to the elasticity of the base 30, no matter which side of the lumen wall to be treated is inclined with respect to the catheter shaft 40, a part of the loop-shaped part 120 does not float from the tissue to be treated and is not separated. The ring-shaped electrode 129R and one tip electrode 129T can be easily disposed at a desired position, and accurate intracardiac potential measurement, myocardial electrical stimulation, and the like can be easily performed.
The electrode catheter 101 of FIG. 4 includes the light diffuser 29 of the catheter 1 of FIGS. 1 and 2 and a known reflector (not shown), and includes laser ablation, a plurality of ring electrodes 129R, and one tip electrode 129T. You may comprise so that it may have the function of the electric potential measurement using.

<Embodiment 3 Catheter 201>
FIG. 5 shows the head portion 210 of the catheter 201 according to the third embodiment.
The present embodiment is an example in which the shape of the base 30 of the first embodiment is changed to a base 230.
The base portion 230 is continuous with the proximal end portion 223 of the loop-shaped portion 220, and has a rising portion 231 erected with an angle from the proximal end portion 223, and an extension portion 232 continuously extending from the rising portion 231. And a bent portion 233 which is continuous from the extension portion 232 and extends in the extension direction of the catheter shaft 40 extending in the axial direction of the loop-shaped portion 220 and a connection portion 234 connected to the catheter shaft 40 are integrally configured. .

The rising portion 231 is bent at an obtuse angle from the loop-shaped portion 220, so that an angle β (first angle) of about 5 to 70 °, preferably about 15 to 60 °, from the surface P2 formed by the loop-shaped portion 220. Hold and bend to stand up proximally.
The extension portion 232 is in the proximal direction away from the loop-shaped portion 220 while drawing an arc shape when viewed from the P direction in FIG. 2 while maintaining the angle with the surface P2 formed by the loop-shaped portion 220 at β. It extends to. The extension portion 232 passes through a region surrounded by a circle formed by the loop-shaped portion 220, and the arc shape is formed more gently than the arc drawn by the loop-shaped portion 220.

In addition, although the extension part 232 is inclined to the same direction as the rising part 231 with respect to the surface P2 in the direction away from the loop-shaped part 220, the extension part 232 may be formed in parallel with the surface P1. However, the angle may be smaller than the rising portion 231, for example, about 5 ° with respect to the surface P <b> 2.
The bent portion 233 is bent so as to be connected to the connection portion 234 that is continuous from the extension portion 232 and is substantially perpendicular to the surface P2. The proximal end portion of the connection portion 234 is connected to the distal end portion of the catheter shaft 40 by an adhesive or welding.

The bent portion 233, the connecting portion 234, and the catheter shaft 40 are arranged substantially perpendicular (second angle) to the surface P2, and as shown in FIG. 5 (A), P in FIG. When viewed in the direction, on the circumference formed by the loop-shaped portion 220, the point facing the distal end 221 and the proximal end 223, that is, the circumference around the center E of the circle It is arranged at a position overlapping with a point moved along an angle of 180 ° to 270 °, preferably 200 to 230 °.
Further, the bent portion 233, the connecting portion 234, and the catheter shaft 40 are not limited to positions overlapping with the circumference formed by the loop-shaped portion 220 when viewed in the P direction in FIG. ) In the region surrounded by a circle formed by the loop-shaped portion 220 when viewed in the P direction.

The base 230 of the present embodiment has an arc shape that is gentler than the arc drawn by the loop-shaped portion 220 when viewed from the P direction in FIG.
In the laser catheter 201 of this embodiment, since the head portion 210 is configured as described above, the base portion 230 exhibits elasticity to treat the loop-shaped portion 220 as in the head portion 10 of the first embodiment. The desired lumen wall of interest can be contacted.
The head portion 210 has the shape shown in FIG. 5 in a state where no external force is applied. When the head portion 210 is pressed against the lumen wall of the tissue to be treated, the base portion 230 is contracted by the pressing force. Therefore, regardless of which side of the lumen wall to be treated is inclined with respect to the catheter shaft 40, a part of the loop-shaped portion 220 does not float from the tissue to be treated and is not separated.
Therefore, unlike the conventional catheter shown in FIG. 13, the position where the head unit 10 contacts first is not selected, and high skill is not required to arrange the head unit 10. In a cardiac catheter procedure that must be performed in a short time, the time required for placement of the catheter can be shortened.
Since the other structure of the catheter 201 of FIG. 5 is the same as that of the catheter 1 of FIG. 1, FIG. 2, description is abbreviate | omitted.

<Embodiment 4 Catheter 301>
FIG. 6 shows the head portion 310 of the catheter 301 according to the fourth embodiment.
The present embodiment is an example in which the shapes of the loop-shaped portion 20 and the base portion 30 of the first embodiment are changed to the loop-shaped portion 320 and the base portion 330.
In the present embodiment, as shown in FIG. 6, the proximal end 323 of the loop-shaped portion 320 is on a circle formed by the loop-shaped portion 320 and has turned more than one round from the proximal-side end 323. Placed in position. The proximal end 323 is located at a position shifted from the point 324 that overlaps the distal end 321 on the circle formed by the loop-shaped portion 320 to the proximal side by about 25 to 50 °.

The base portion 330 is continuous with the proximal end portion 323 of the loop-shaped portion 320, and a rising portion 331 standing at an angle from the proximal side end portion 323, and an extension portion 332 continuously extending from the rising portion 331. And a bent portion 333 that is continuous from the extension portion 332 and extends in the extension direction of the catheter shaft 40 extending in the axial direction of the loop-shaped portion 320, and a connection portion 334 connected to the catheter shaft 40 are integrally configured. .

The rising portion 331 is bent at an obtuse angle from the loop-shaped portion 320, whereby an angle γ (first angle) of about 5 to 30 °, preferably about 5 to 15 °, from the surface P3 formed by the loop-shaped portion 320. Hold and bend to stand up proximally.
The extension portion 332 is a straight line as shown in FIG. 6A when viewed from the P direction in FIG. 6B while gradually increasing the angle with the surface P3 formed by the loop-shaped portion 320 from γ. And extending in a proximal direction away from the loop-shaped portion 320. The extension part 332 crosses the circle formed by the loop-shaped part 320 linearly along the diameter.
The bent portion 333 is bent so as to be connected to the connection portion 334 that is continuous from the extension portion 332 and is substantially perpendicular to the surface P3. The proximal end of the connecting portion 334 is connected to the distal end of the catheter shaft 40 by an adhesive or welding.
The region from the rising portion 331 to the bent portion 333 of the base 330 is curved so that the inclination angle gradually increases from the distal rising portion 331 toward the proximal bent portion 333. Yes.

The bent portion 333, the connecting portion 334, and the catheter shaft 40 are disposed substantially perpendicularly (second angle) with respect to the surface P3. As shown in FIG. 6 (A), P in FIG. When viewed in the direction, on the circumference formed by the loop-shaped portion 320, the point facing the proximal end 323, that is, about 180 ° along the circumference around the center E of the circle, that is, It is arranged at a position overlapping with the point moved by an angle of 160 to 200 °, preferably 175 to 185 °.
Further, the bent portion 333, the connecting portion 334, and the catheter shaft 40 are not limited to positions overlapping with the circumference formed by the loop-shaped portion 320 when viewed in the P direction in FIG. ) In the region surrounded by a circle formed by the loop-shaped portion 320 when viewed in the P direction.

In the laser catheter 301 of the present embodiment, since the head portion 310 is configured as described above, the base portion 330 exhibits elasticity and the loop-shaped portion 320 is treated similarly to the head portion 10 of the first embodiment. The desired lumen wall of interest can be contacted.
Since the other structure of the catheter 301 of FIG. 6 is the same as that of the catheter 1 of FIG. 1, FIG. 2, description is abbreviate | omitted.
In the catheter 301 of FIG. 6, the loop-shaped portion 320 is wound clockwise from the distal end portion 321 to the proximal end portion 323. However, the present invention is not limited to this, and FIG. As shown in the catheter 301 ′, it may be wound counterclockwise.

<Embodiment 5 Catheter 401>
FIG. 9 shows the head portion 410 of the catheter 401 according to the fifth embodiment.
The head portion 410 includes a base portion 430 whose end portion is connected to the distal end of the catheter shaft 40 by an adhesive or welding, and a loop-like portion 420 continuously provided on the distal side of the base portion 430. Formed.
The loop-shaped portion 420 is formed in a spiral shape of more than one turn in a state where the distal end portion 421 to the proximal end portion 423 are not subjected to external force. The loop-shaped portion 420 has a spiral shape in which the distal end portion 421 and the proximal-side end portion 423 are separated from each other in a state where no external force is applied. When used, the distal end 21 and the proximal end 23 are in contact and used in a closed loop.
A rough surface 424 having fine irregularities on the surface is formed on the outside of the spiral shape near the distal end 421 of the loop-shaped portion 420. The rough surface 424 is brought into contact with the tissue to be treated as a support point, and the catheter shaft 40 is rotated in the J direction or the K direction in FIG. 9A to match the shape of the lumen of the tissue to be treated. It is used to transform the spiral shape of the loop-shaped portion 420 into a large loop shape or a small spiral shape.

Note that the reduction and enlargement of the diameter of the spiral shape formed by the loop-shaped portion 420 is due to the flexibility of the material forming the loop-shaped portion 420, the friction on the surface of the loop-shaped portion 420, and the magnitude of the torque applied when reducing and expanding. This is achieved when the balance becomes the right balance.
When the material of the loop-shaped part 420 has sufficient flexibility, even if the rough surface 424 is not provided, the balance is appropriate, and therefore the rough surface 424 may not be formed.
Further, similarly to the loop-shaped portion 20 of the first embodiment, the loop-shaped portion 420 has a spiral-shaped diameter contracted and reduced in the loop-shaped portion 420 over the entire length of the loop-shaped portion 20. The contraction wire (not shown) is inserted along the length direction, and by pulling or rewinding the contraction wire with an operation handle (not shown), the diameter of the spiral shape of the loop-shaped portion 420 is increased. It is configured to be adjustable.

A base 430 extends proximally from the proximal end 423 of the loop-shaped portion 420.
The base portion 430 is continuous with the proximal end portion 423 of the loop-shaped portion 420, a rising portion 431 standing upright from the proximal end portion 423, and an extension portion 432 continuously extending from the rising portion 431. And a bent portion 433 which is continuous from the extension portion 432 and extends in the extension direction of the catheter shaft 40 extending in the axial direction of the loop-shaped portion 420 and a connection portion 434 connected to the catheter shaft 40 are integrally configured. .

The rising portion 431 is bent at an obtuse angle from the loop-shaped portion 420, whereby an angle δ (first angle) of about 40 to 70 °, preferably about 45 to 60 °, from the surface P4 formed by the loop-shaped portion 420. Hold and bend to stand up proximally.
The extension part 432 is close to the loop part 420 while drawing a straight line when viewed from the P direction in FIG. 9B while keeping the angle with the surface P4 formed by the loop part 420 at δ. It extends in the direction of the position.
The bent portion 433 is bent so as to be connected to the connection portion 434 that is continuous from the extension portion 432 and is substantially perpendicular to the surface P4. The proximal end of the connecting portion 434 is connected to the distal end of the catheter shaft 40 by an adhesive or welding.

The bent portion 433, the connecting portion 434, and the catheter shaft 40 are arranged substantially perpendicular (second angle) to the surface P4, and as shown in FIG. 9A, the P direction in FIG. 9B. When viewed in the above, the positions are opposed to each other in the radial direction of the spiral shape formed by the loop-shaped portion 420, more specifically, at the center side of the spiral shape formed by the loop-shaped portion 420.
In the catheter 401 of this embodiment, after the loop-shaped portion 420 reaches the lumen of the tissue to be treated, the rough surface 424 is brought into contact with the inner wall of the lumen and the frictional force between the rough surface 424 and the inner wall of the lumen is caused. By fixing the rough surface 424 to the inner wall of the lumen and rotating the catheter shaft 40 in the K direction, the spiral shape of the loop-shaped portion 420 can be reduced according to the thin lumen as shown in FIG. Further, by rotating the catheter shaft 40 in the J direction, the spiral shape of the loop-shaped portion 420 can be increased in accordance with the thick lumen as shown in FIG.

E Center P1, P2, P3, P4 plane W Target tissue α, β, γ, δ, ε Angle 1

Laser catheter

10, 110, 210, 310, 710

Head portion

20, 120, 220, 320, 420, 720

Loop shape Portions

21, 121, 221, and 321

Distal end portions

23, 223, and 323 Proximal end portions 29 Light diffuser 30

Base portions

31, 131, 231, and 331 Rising

portions

32, 132, 232, and 332

Extension portions

33 and 133 , 233, 333, 733

Bent part

34, 134, 234, 334, 734

Connection part

40, 740 Catheter shaft 101 Electrode catheter

129R Ring electrode

129T Tip electrode

201, 301, 301 ', 401, 700 Catheter 324 Point 424 Rough surface

Claims

A catheter with a tubular tip,
The tip portion includes a base portion extending from the proximal side to the distal side of the catheter, and a spiral loop portion extending continuously from the distal end portion of the base portion,
The base portion is adjacent to the loop-shaped portion, and rises from the loop-shaped portion with a first angle with respect to a surface formed by the loop-shaped portion, and is bent with respect to the rising portion, A shaft portion having a second angle larger than the first angle with respect to the surface,
The catheter is characterized in that the shaft portion is disposed at a position facing the proximal end portion of the loop-shaped portion in the direction of the surface.
The base portion includes an extension portion extending between the rising portion and the shaft portion,
The catheter according to claim 1, wherein the shaft portion is disposed in a region overlapping or surrounded by the loop-shaped portion when viewed from the axial direction of the spiral shape.
The catheter according to claim 1, wherein the surface formed by the loop-shaped portion is substantially flat.
2. The shaft portion is disposed at a position facing a proximal end portion of the loop-shaped portion in a direction substantially identifiable with the radial direction of the spiral shape. The catheter described.
The catheter according to claim 2, wherein the rising portion and the extension portion overlap the loop-like portion when viewed from the axial direction of the spiral shape.
The catheter according to claim 2, wherein the rising part and the extension part pass through a region surrounded by the loop-like part when viewed from the axial direction of the spiral shape.
The catheter according to claim 6, wherein the rising portion and the extension portion are curved in the same direction as a distal portion of the loop-shaped portion.
The catheter according to claim 6, wherein the rising portion and the extension portion include a portion that is substantially straight when viewed from the axial direction of the spiral shape.
The catheter according to claim 1, wherein the spiral-shaped outer peripheral surface of the loop-shaped portion has a rough surface that can be locked to a living tissue in the vicinity of a distal end portion of the loop-shaped portion.