KR101758441B1 - Electrode catheter - Google Patents

Abstract

A lumen 11 serving as a liquid channel is provided with a catheter shaft 10 having an eccentric shape and a lumen member 20 and a front electrode 30. The lumen 11 is provided with a plurality of coaxial openings 25A, An eccentric flow passage 23 communicating with the lumen 11 of the shaft 10 and a liquid reservoir space 24 communicating with the eccentric flow passage 23 and having no partition wall in the circumferential direction are disposed in the interior of the housing member 20, And a plurality of branching flow paths 25 extending in the tip direction and reaching each of the leg opening 25A are formed in such a manner as to be communicated with the tubular member 20 and inclined outwardly, Two parts 22 and an eccentric flow path 23 is formed in the second part 22. The branching flow path 25 is formed in the first part 21, And a reservoir space (24) is formed in the electrode catheter. According to this electrode catheter, the liquid supplied from the lumen of the shaft 10 having the eccentricity can be uniformly circumferentially aligned with the surface of the tip electrode 30.

Description

ELECTRODE CATHETER

The present invention relates to an electrode catheter, and more particularly, to an electrode catheter having an electrode attached to the tip of a catheter and a mechanism for moving a liquid such as physiological saline into the electrode.

An ablation catheter, which is an electrode catheter, is provided with a plunger mechanism for cooling a tip electrode that has become hot during cauterization.

As a conventional catheter having a plunger mechanism, there has been introduced a type in which physiological saline supplied into the tip electrode through a catheter shaft is jetted from a plurality of openings formed on the surface of the tip electrode (see, for example, Patent Document 1 And Patent Document 2).

However, a conventionally known catheter in which an opening for a cap is formed on the surface of the tip electrode has the following problems (1) to (4).

(1) If an opening is formed on the surface of the tip electrode, an edge is unavoidably formed at the opening edge or the like. When cauterization is performed by the tip electrode having such an edge, the current density at the edge portion becomes extremely high, and an abnormal temperature rise occurs at this portion, and the thrombus may be formed rapidly.

(2) Even if physiological saline is sprayed from the opening formed on the surface of the tip electrode, it is impossible to perform sufficient coplanarity with the surface of the tip electrode (covering the surface with liquid). Particularly, in the catheters described in Patent Documents 1 and 2, in which physiological saline is sprayed in a direction perpendicular to the axis of the tip electrode, physiological saline can not sufficiently contact the surface of the tip electrode.

(3) By forming a plurality of openings on the electrode surface, the surface area of the tip electrode can not be sufficiently secured, and efficient cauterization treatment can not be performed.

(4) Inside the tip electrode constituting the ablation catheter, a normal temperature sensor is provided, and cauterization treatment is performed while monitoring and controlling the temperature of the tip electrode and surrounding tissues.

However, in the catheters described in Patent Documents 1 and 2, the distal electrode is cooled more than necessary by physiological saline supplied to the inside (flow path) of the distal electrode, and the temperature sensor provided inside the distal electrode There is a problem that accurate temperature monitoring and control at the time of cauterization treatment is impossible. In order to solve such a problem, a technique has been disclosed in which a cap member for inserting a heat insulating material is provided between the tip electrode on which the temperature sensor is disposed and the catheter shaft to prevent the tip electrode from being cooled unnecessarily by physiological saline (See Patent Document 3).

Japanese Patent No. 2562861 Japanese Patent Application Laid-Open No. 2006-239414 Japanese Patent Publication No. 2009-537243

A leaf spring is often used as a biasing mechanism for performing a tip deflection operation of the catheter.

The leaf spring is disposed along the central axis of the catheter shaft at the distal end flap portion of the catheter shaft. By adopting a leaf spring as a biasing mechanism, sufficient torsional rigidity is imparted to the tip end flexible portion, and operability as a tip deflectable catheter is improved.

However, when the electrode catheter having the plunger mechanism is adopted as the biasing mechanism by the leaf spring, it is not possible to form the lumen which becomes the flow path of the saline solution at the tip end flexible portion of the catheter shaft along the central axis, Should form.

Further, since the flow path of the saline solution in the tip electrode or the cap member connected to the catheter shaft is also formed eccentrically from the central axis, the saline solution is injected from the eccentric opening (outlet of the flow path).

Thus, depending on the physiological saline solution sprayed from the eccentric opening through the eccentric flow path, there is a problem that it can not be uniformly circumferentially circumferential to the tip electrode.

To solve this problem, it is conceivable to increase the number of injection openings (the outlets of the flow paths) arranged in the tip electrode or the cap member to achieve uniformity in the circumferential direction.

However, in order to increase the number of the injection openings (the outlets of the flow path), it is necessary to increase the number of the flow paths formed in the tip electrode or the cap member, and furthermore, the number of lumens constituting the flow path formed in the catheter shaft.

The present invention has been made based on the above-described circumstances.

SUMMARY OF THE INVENTION An object of the present invention is to provide an electrochemical device which is excellent in the cooling effect on the surface of the front end electrode and the effect of suppressing the formation of thrombus on the surface of the front electrode without causing an abnormal temperature rise (high temperature portion) And further to provide an electrode catheter in which the liquid from the lumen of the catheter shaft formed to be eccentric can be evenly circumferentially aligned with the surface of the tip electrode.

[1] An electrode catheter of the present invention comprises a catheter shaft having a distal flexible portion and at least one lumen to be a liquid channel formed eccentrically in the distal flexible portion, and an insulated conduit connected to the distal end side of the catheter shaft And an end electrode connected to a distal end side of the insulating cap member,

Wherein the insulating cap member is provided with a plurality of capillary openings for conforming the liquid supplied from the catheter shaft to the surface of the tip electrode at equal angular intervals along the periphery of the insulating cap member,

At least one eccentric flow passage communicating with a lumen which becomes a liquid flow path of the catheter shaft,

A liquid reservoir space communicating with the eccentric flow path and having no partition in the circumferential direction so that liquid from the eccentric flow path is uniformly distributed in a circumferential direction of the insulating cap member;

A plurality of branch channels communicating with the storage space and extending in the tip direction while being inclined outward to reach each of the plurality of pipe fitting openings is formed,

The insulating cap member is composed of a first component having a tip shape that can be fitted to the shape of the rear end of the tip electrode and a second component having a tip shape fittable to the shape of the rear end of the first component,

The eccentric flow path is formed inside the second part,

The plurality of branch channels are formed in the first component,

And the retention space is formed at a fitting portion between the first component and the second component.

(a) According to the electrode catheter having such a constitution, since an opening for cooperating is formed in the insulating cap member, there is no need to form an opening in the tip electrode, and there is no edge accompanying the formation of the opening, An abnormal temperature rise does not occur in a part of the tip electrode, thereby suppressing the formation of thrombus. Further, since there is no need to form an opening in the tip electrode, a sufficient surface area can be ensured and efficient cauterization treatment can be performed.

(b) Since the liquid is coordinated with the surface of the tip electrode from the insulating cap member, a sufficient amount of liquid can be brought into contact with the surface of the tip electrode, and the liquid running along the surface of the tip electrode, The tip end electrode has an excellent surface cooling effect and an excellent thrombosis formation inhibiting effect is exhibited even when the blood around the tip electrode surface is sufficiently stirred and diluted.

(c) Since a plurality of pipe-fitting openings are formed at equi-angular intervals along the outer periphery of the insulating cap member, it is possible to move around the entire circumference of the surface of the tip electrode.

(d) Since the lumen to be a liquid channel is eccentrically formed at the distal end flexible portion of the catheter shaft, the leaf spring, which can not be disposed in the conventional diaper catheter having the diaphragm, is moved along the central axis of the catheter shaft It becomes possible to arrange it.

(e) Since the eccentric flow path is formed inside the insulating cap member, the liquid from the lumen (eccentrically formed liquid flow path) of the catheter shaft can flow toward the reservoir space.

(f) In addition, in the insulating cap member, a liquid storage space which does not have a partition wall in the circumferential direction thereof, and a liquid storage space which communicates with the storage space and which extends in the tip direction while being inclined outward, The liquid that has reached the storage space through the eccentric flow path is flowed so as to be uniformly distributed in the circumferential direction in the storage space and then flows through the plurality of branch flow paths extending in the tip direction So that there is no variation in the amount of liquid sprayed between the plurality of leg openings arranged at equal angular intervals and uniform spraying (circumference) in the circumferential direction of the insulating cap member is prevented So that the surface of the tip electrode can be evenly distributed over the entire circumferential direction.

(g) Since the branch flow path formed inside the insulating cap member is formed so as to be inclined to the outside (outside in the radial direction of the insulating cap member), the cap opening (opening of the branch flow path) , It is possible to cooperate with the surface of the distal electrode having a somewhat larger size (for example, the distal electrode having a diameter equal to or larger than the diameter of the catheter shaft).

(h) Further, the insulating cap member is formed by fitting the shape of the rear end of the first part and the shape of the tip of the second part, and the shape of the rear end of the tip electrode and the shape of the tip of the first part are fitted, The tip electrode can be connected to the tip end side of the cap member.

In addition, since the insulating cap member is composed of two parts, it is possible to avoid the problem of undercut, and it becomes possible to obtain an insulating cap member in which the eccentric flow path, the storage space, and the plurality of branch paths are formed.

[2] In the electrode catheter of the present invention, a liquid guiding groove continuously extending from each of the plurality of branching openings in the tip direction is formed in the distal end portion of the insulating cap member, And,

It is preferable that the base end of the tip electrode is formed with a guide groove of liquid continuous to each of the guide grooves of the insulating cap member.

According to the electrode catheter having such a configuration, since the liquid guiding groove extending in the tip direction continuously to each of the plurality of branching channels is formed at the tip end portion of the insulating cap member, the liquid (The liquid reaching the opening for the capillary through the capillary tube) toward the tip electrode.

Since the liquid guide grooves continuous to the guide grooves of the insulating cap member are formed on the base end surface of the tip electrode, the liquid reaching the base end of the tip electrode through the guide groove formed in the insulating cap member, (Guided) to the tip of the electrode, whereby the liquid can be supplied to the entire surface of the tip electrode.

[3] In the electrode catheter of the present invention, the insulating cap member is formed by fitting a rear end side concave portion formed in the first component and a small diameter portion at the distal end side of the second component,

The depth of the rear end side concave portion of the first component is formed to be deeper than the length of the small diameter portion at the front end side of the second component so that in the fitting portion between the first component and the second component, .

According to the electrode catheter having such a configuration, by fitting the first part and the second part, the bottom surface (rear end surface) and the inner circumferential surface of the rear end concave portion of the first part and the line And an insulating diaphragm member having a plurality of diverging flow paths formed inside the first component, and a second diaphragm member having a first diaphragm member and a second diaphragm member, .

[4] In the electrode catheter of the present invention, it is preferable that the first component and the second component constituting the insulating cap member are formed by a ceramic injection molding method (CIM).

According to the ceramic injection molding method, a fine shape that can not be formed by injection molding using a resin can be formed, and the insulating cap member constituting the electrode catheter of the present invention can be reliably molded.

In addition, the ceramic formed body obtained by the ceramic injection molding method has a suitable insulating property and a low thermal conductivity as a constituent material of the driving member.

[5] In the electrode catheter of the present invention, it is preferable that the biasing mechanism for bending the distal end flexible portion of the catheter shaft includes a leaf spring extending along the central axis of the catheter shaft.

The electrode catheter having such a structure is excellent in operability because a sufficient torsional rigidity is imparted to the distal end flexible portion of the catheter shaft. Furthermore, according to this electrode catheter, the leaf spring is disposed along the central axis of the catheter shaft to uniformly move in the circumferential direction with respect to the surface of the distal electrode, although the lumen to be the liquid channel is formed eccentrically.

[6] In the electrode catheter of the present invention, it is preferable that the lumen as the liquid channel of the catheter shaft and the eccentric channel of the insulating cap member are communicated through the joint tube.

According to the electrode catheter having such a configuration, it is possible to reliably connect the insulating cap member to the distal end side of the catheter shaft, and to secure the distal end face of the catheter shaft (distal end face where the lumen as the liquid channel opens) It is possible to prevent the leakage of the liquid at the contact portion of the rear end face of the diaphragm member (the rear end face of the second part in which the eccentric flow passage is opened) (the penetration of the liquid into the shaft accompanying thereto).

[7] In the electrode catheter of the present invention, it is preferable that the number of eccentric flow passages formed in the insulative cylindrical member is 1 or 2, and the number of branch passages is 4 or more.

When the number of eccentric flow paths formed inside the insulating cap member is 1 or 2 (that is, when the number of lumens constituting the liquid flow path of the catheter shaft is 1 or 2), the insulating cap member is mounted on the tip end side of the catheter shaft (Circulating the liquid supplied from the catheter shaft to the inside of the insulating cap member (the eccentric channel, the reservoir space, the plurality of branch channels)) is particularly effective.

Further, if the number of the branching flow paths (the number of openings for the legs) is 4 or more, it is possible to make a sufficient uniform movement in the circumferential direction of the insulating control member.

[8] In the electrode catheter of the present invention, a center through hole is formed along the center axis of the insulating cap member, a center tube is inserted through the center through hole,

Preferably, the liquid storage space is a jacket space defined by an inner circumferential surface of the rear end concave portion of the first component and an outer circumferential surface of the center tube.

According to the electrode catheter having such a configuration, by fitting the first part and the second part, the bottom surface (rear end surface) of the rear end side concave portion of the first part and the front end surface of the small- , The inner peripheral surface of the rear end side concave portion of the first component and the outer peripheral surface of the center tube can be used as the retention space.

[9] In this case, it is preferable that a lead wire of the tip electrode and / or a lead wire of a temperature sensor is inserted into the center tube.

According to the electrode catheter having such a configuration, it is possible to reliably prevent the lead wire inserted into the center tube from coming into contact with the liquid.

In the electrode catheter of the present invention, when the distal end of the distal electrode is bulged and the maximum diameter of the distal electrode is D1 and the tube diameter of the catheter shaft is D2, the value of D1 / D2 is 1.0 or more .

According to the electrode catheter having such a configuration, a surface area sufficient for cauterization treatment can be secured at the tip electrode.

According to the electrode catheter of the present invention, it is possible to perform effective cauterization treatment without causing abnormal temperature rise in a part of the tip electrode at the time of cauterization, excellent cooling effect on the surface of the tip electrode, and effect of inhibiting the formation of thrombus on the surface of the tip electrode .

According to the electrode catheter of the present invention, the liquid from the lumen of the eccentrically formed catheter shaft can be evenly circumferentially aligned with the surface of the tip electrode. Further, since the lumen, which becomes the liquid channel, is formed eccentrically at the distal end flexible portion of the catheter shaft, it is possible to arrange the leaf spring, which could not be arranged in the conventional diaper catheter having the diaphragm member, along the central axis of the catheter shaft .

Further, since the first and second parts constitute the insulating cap member, the problem of undercut during molding can be avoided, and an insulating cap member having the eccentric flow path, the storage space, and the plurality of branch paths formed therein can be formed .

1 is a front view of an ablation catheter according to an embodiment of the electrode catheter of the present invention.
Fig. 2 is a longitudinal sectional view of the distal end portion of the ablation catheter shown in Fig. 1; Fig.
Fig. 3 is a cross-sectional view at the distal end portion of the ablation catheter shown in Fig. 1 (a cross-sectional view taken along line CC in Fig. 2 (Fig. 7)).
Fig. 4 is a cross-sectional view (BB sectional view of Fig. 2 (Fig. 7)) at the distal end portion of the ablation catheter shown in Fig.
Fig. 5 is a cross-sectional view (DD sectional view of Fig. 2 (Fig. 7)) at the distal end portion of the ablation catheter shown in Fig.
Fig. 6 is a cross-sectional view (AA sectional view of Fig. 2 (Fig. 7)) at the distal end portion of the ablation catheter shown in Fig.
7 is a vertical sectional view (a cross-sectional view taken along line FF of Fig. 3) at the distal end portion of the ablation catheter shown in Fig.
Fig. 8 is a perspective view showing a connecting member constituting the ablation catheter shown in Fig. 1. Fig.
Fig. 9 is a perspective view showing a connecting member constituting the ablation catheter shown in Fig. 1. Fig.
10 is a longitudinal sectional view (a sectional view taken along a line GG in Fig. 4) at the distal end portion of the ablation catheter shown in Fig.
Fig. 11 is a cross-sectional view (a cross-sectional view taken along the line HH in Fig. 10) at the distal end portion of the ablation catheter shown in Fig.
FIG. 12 is a cross-sectional view (cross-sectional view taken along line II in FIG. 10) at the distal end portion of the ablation catheter shown in FIG.
Fig. 13 is a cross-sectional view (a cross-sectional view taken along the line JJ in Fig. 10) at the distal end portion of the ablation catheter shown in Fig.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, one embodiment of the electrode catheter of the present invention will be described with reference to the drawings.

The electrode catheter shown in Figs. 1 to 7 and Figs. 10 to 13 is an ablation catheter of the present invention used for treatment of arrhythmias in the heart.

The ablation catheter 100 of the present embodiment has a catheter shaft 10A having a distal end flexible portion 10A and two lumens 11 and 11 formed as eccentrically formed in the distal end flexible portion 10A A distal end electrode 30 connected to the distal end side of the cap member 20 and an outer circumferential surface 30 of the catheter shaft 10 connected to the distal end side of the catheter shaft 10, Shaped electrodes 40 mounted on the catheter shaft 10 and tension wires 61 and 62 constituting a biasing mechanism for bending the distal flexible portion 10A of the catheter shaft 10 A leaf spring 65 constituting a deflection mechanism together with the tension wires 61 and 62 and a control handle 70 connected to the proximal end side of the catheter shaft 10 and a liquid injection tube 80 ;

Two lumens 11 and 11 serving as liquid passages are formed in the distal end flexible portion 10A of the catheter shaft 10 so as to face each other with the central axis therebetween (i.e., each of them is eccentric from the central axis) Two lumens 12 and 12 serving as insertion passages of the tension wires 61 and 62 and two lumens 13 and 13 serving as lead wire insertion passages of the ring electrode 40;

Eight piping openings 25A for spraying (moving) the liquid supplied from the catheter shaft 10 to the surface of the tip electrode 30 are formed in the cap member 20 along the periphery of the cap member 20 Are arranged at equal angular intervals (45 degrees apart)

Two eccentric flow passages 23 and 23 communicating with the lumens 11 and 11 serving as the liquid flow passages of the catheter shaft 10 and a space communicating with the eccentric flow passages 23 and 23 A liquid reservoir space 24 having no partition walls in the circumferential direction so that the liquid from the eccentric flow paths 23 and 23 is uniformly distributed in the circumferential direction of the pipe member 20, Eight branching flow passages 25 extending to the respective eight openings 25 for regulation are formed and the eight branching flow passages 25 are formed in the tip end portion of the centering member 20, A liquid guiding groove 26 extending from each of the pipe fitting openings 25A in the front end direction is formed;

A liquid guiding groove 36 continuous to each of the guide grooves 26 of the cap member 20 is formed on the base end surface of the tip electrode 30;

The cap member 20 is formed with the tip side concave portion 21A that can be fitted to the cylindrical portion 33 of the tip electrode 30 and the concave portion 21B is formed on the back end side, The first component 21 having eight branch flow paths 25 and the distal end small diameter portion 221 engageable with the rear end concave portion 21B of the first component 21, And a second part (22) having two eccentric flow paths (23, 23) formed therein is fitted in the first part (22);

Since the depth d ₂₁ of the rear end concave portion 21B of the first component ₂₁ is formed to be deeper than the length d ₂₂ of the small diameter portion 221 on the tip side of the second component 22, The bottom surface (rear end surface) 21b of the rear end side concave portion 21B of the first component 21 and the bottom surface (rear end surface) 21b of the first component 21 in the fitting portion of the first component 21 and the second component 22, A space defined by the inner circumferential surface and the distal end surface 22a of the small diameter portion 221 on the distal end side of the second component 22).

1, the ablation catheter 100 includes a catheter shaft 10 having a distal flexible portion 10A, a connecting member 20, a distal electrode 30, a ring electrode 40 ), A control handle (70), and a liquid injection pipe (80).

The injection tube 80 shown in Figure 1 is connected to the catheter shaft 10 through the interior of the control handle 70 and is connected to the lumen 11 of the catheter shaft 10 via the injection tube 80, . As the " liquid ", physiological saline can be mentioned.

The control handle 70 shown in Fig. 1 is connected to the base end side of the catheter shaft 10 and has a rotation plate 75 for performing a tip deflection operation of the catheter.

The catheter shaft 10 constituting the ablation catheter 100 has the tip end flexible portion 10A.

Here, the "tip end flexible portion" refers to the distal end portion of the catheter shaft which can be bent (bent) by pulling the tip deflection operation wire.

As shown in Figs. 2 and 3, the catheter shaft 10 (lumens 12 and 12) is provided with tensile wires 61 and 62 for bending the tip flexible portion 10A Respectively. The rear ends of the tension wires 61 and 62 are connected to the rotary plate 75 (see Fig. 1) of the control handle 70, respectively. On the other hand, the distal ends of the tensioning wires 61 and 62 are fixed in the outer circumferential surface (accommodating groove 226) of the diaphragm member 20 (second component 22).

For example, when the rotary plate 75 is rotated in the direction of A1 shown in Fig. 1, the tension wire 61 is pulled and the distal end flexible portion 10A of the catheter shaft 10 deflects in the direction of the arrow A, The distal end flexible portion 10A of the catheter shaft 10 deflects in the direction of the arrow B when the rotation plate 75 is rotated in the direction B1 shown in Fig.

3, on the tip end flexible portion 10A of the catheter shaft 10, on a plane perpendicular to the arranging direction of the tensile wires 61, 62 (the bending direction of the tip end flexible portion 10A) So that the leaf spring 65 is disposed along the central axis of the catheter shaft 10.

By arranging the leaf spring 65 on the tip end flexible portion 10A, the anisotropy in the bending direction is ensured and sufficient torsional rigidity is imparted to the tip end flexible portion 10A, thereby improving the operability during the tip deflection operation .

3 and 7, the distal end flexible portion 10A of the catheter shaft 10 is provided with two lumens 11 and 11 serving as liquid passages so as to face each other with the central axis of the catheter shaft 10 therebetween. Respectively.

The two lumens 11 and 11 at the tip end flexible portion 10A may be joined at the shaft portion on the proximal end side of the tip end flexible portion 10A.

3, the tip end flexible portion 10A is provided with two lumens 12 and 12 serving as insertion passages of the tension wires 61 and 62 and a lead wire (not shown) of the ring electrode 40 Two lumens 13 and 13 serving as insertion passages of the temperature sensor (thermocouple), a lumen 14 serving as a passage for inserting the lead wire 30L of the tip electrode 30, A lumen 15 is formed to be an insertion passage of the lead wire 35L of the first embodiment. As described above, the distal end flexible portion 10A of the catheter shaft 10 has a so-called multi-lumen structure. However, the tip end of the catheter shaft 10 is formed with a tip side concave portion of a single lumen structure for joining with the laterally-described cap member 20.

The catheter shaft 10 is made of synthetic resin such as polyolefin, polyamide, polyether polyamide, polyurethane, nylon, PEBAX (polyether block amide), and the like. Further, the proximal end side of the catheter shaft 10 may be a blade tube formed by brazing a tube containing these synthetic resins with a stainless steel wire.

The outer diameter of the catheter shaft 10 is preferably 1.0 to 3.0 mm, more preferably 1.6 to 2.7 mm, and a suitable example is 2.36 mm.

The length of the catheter shaft 10 is preferably 600 to 1500 mm, more preferably 900 to 1200 mm.

In the ablation catheter 100, the injection of the liquid to the surface of the tip electrode 30 is performed by the cap member 20 located on the rear end side of the tip electrode 30.

Figs. 8 and 9 are perspective views showing the shape of the housing member 20 constituting the ablation catheter 100. Fig.

As shown in Figs. 2 and 7 to 10, the cap member 20 is formed by fitting the first part 21 and the second part 22 together.

The second component 22 constituting the cage member 20 includes a molded body in which a straight body 223 and a tip small diameter portion 221 having an outer diameter smaller than that of the straight body 223 are integrally formed do.

8 and 9, the distal end small diameter portion 221 of the second component 22 is fitted to the inside (the rear end concave portion 21B) of the first component 21 They are not shown in the drawing.

The outer diameter of the linear body portion 223 of the second component 22 is preferably 0.80 to 2.80 mm, more preferably 1.80 to 2.12 mm, and more preferably 1.96 mm.

The outer diameter of the small diameter portion 221 on the distal end side of the second component 22 is preferably 0.60 to 2.60 mm, more preferably 0.40 to 1.70 mm, and a preferable example is 1.45 mm.

4, 5, 7, and 9, the second component 22 is formed with a central through hole 224 along the center axis thereof, In the abutting portion, eccentric flow passages (23, 23) extending in parallel with the central axis are formed. The center through hole 224 and the eccentric flow paths 23 and 23 are formed so as to extend from the distal end face 22a of the second component 22 (distal small diameter portion 221) to the second component 22 (linear body portion 223 ) To the rear end surface 22b.

7, each of the openings of the eccentric flow passages 23 and 23 in the rear end face 22b of the second component 22 (BB cross section in Fig. 2 shown in Fig. 4) (The CC cross section in Fig. 2 shown in Fig. 3) of the lumens 11 and 11, respectively.

The lumens 11 and 11 of the catheter shaft 10 and the eccentric flow paths 23 and 23 of the connecting member 20 (the second component 22) communicate with each other through the joint tubes 51 and 51.

This makes it possible to secure the connection between the catheter shaft 10 and the connecting member 20 and to secure the connection between the distal end surface of the catheter shaft 10 (opening surface of the lumens 11 and 11) (The opening surface of the eccentric flow paths 23, 23) of the rear end face of the rear end face of the rear end face of the shaft 22, and further, the liquid can be prevented from intruding into the shaft.

7, the transverse sectional shapes of the eccentric flow passages 23, 23 passing through the second component 22 (the straight body portion 223 and the distal end small diameter portion 221) are such that the straight body portion 223 (The step shown by reference numeral 231 in Fig. 7) from the inside of the small diameter portion 221 to the inside of the small diameter portion 221 at the distal end side. Therefore, the opening shape of the eccentric flow passages 23, 23 in the rear end face 22b of the second component 22 (BB cross section in Fig. 2 shown in Fig. 4) is circular, The opening shapes of the eccentric flow passages 23 and 23 in the end face 22a (the DD end face in Fig. 2 shown in Fig. 5) are approximately semicircular.

By changing the cross-sectional shape of the eccentric flow paths 23 and 23, it is possible to secure the thickness (for example, thickness of 60 m or more) of the molding material for partitioning the eccentric flow paths 23 and 23 in the tip small- .

As shown in Figs. 2, 8 and 9, on the outer circumferential surface of the second component 22 (linear body portion 223), there is formed a receiving groove (226, 226) are formed.

As shown in Figs. 8 to 10 and Fig. 13, on the outer peripheral surface of the second component 22 (linear body portion 223), a ring-shaped electrode 40 (first and second rings The shape of the electrode is the same as that of the lead electrode.

As shown in Fig. 10, the receiving groove 225 includes a shallow portion 225a, an inclined portion 225b, and a deep groove portion 225c from the front end toward the rear end portion.

Here, the width of the receiving groove 225 is preferably 0.15 to 0.35 mm, and a suitable example is 0.26 mm.

The depth of the shallow portion 225a of the receiving groove 225 is preferably 0.10 to 0.20 mm, and a preferable example is 0.12 mm.

Further, the depth of the grooved portion 225c of the receiving groove 225 is preferably 0.15 to 0.65 mm, and is 0.50 mm as a suitable example.

The first component 21 constituting the cap member 20 includes a straight body 213, a large diameter portion 212 having an outer diameter larger than that of the straight body 213, Diameter portion 211 is integrally formed.

The outer diameter of the straight body portion 213 of the first component 21 is substantially the same as the outer diameter of the straight body portion 223 of the second component 22 and the outer diameter of the large diameter portion 212 is substantially the same as the outer diameter of the catheter shaft 10, Is substantially the same as the outer diameter. The minimum outer diameter of the diameter reduction portion 211 of the first component 21 is substantially the same as the outer diameter of the neck portion 32 of the tip electrode 30. [

2, 7, and 10, on the tip end side of the first component 21, a tip end concave portion (a cylindrical portion 33) that can be fitted to the rear end portion (cylindrical portion 33) 21A are formed. A rear end side concave portion 21B is formed on the rear end side of the first component 21 so as to be fittable with the front end small diameter portion 221 of the second component 22. [

Here, the depth of the end-side recess portion (21B) after the first part 21 (in Fig. 7, indicated by a d _21), the length (FIG. 7 of the second part (22) distal end side small-diameter portion 221 of the Quot; d ₂₂ " in Fig.

7 and 8, the liquid supplied from the catheter shaft 10 is sprayed (moved) onto the surface of the distal electrode 30, in the first component 21 (the diameter-reduced portion 211) Are arranged at equal angular intervals (at intervals of 45 DEG) along the outer periphery of the raceway member 20. As shown in Fig.

Inside the first part 21, there are formed eight (8) parts extending in the tip direction and inclined outward from the bottom surface (rear end surface) 21b of the rear end side concave portion 21B to each of the leg opening 25A Branch passages 25 (through-holes) are formed.

6, the opening degree of the branch passage 25 in the bottom surface (rear end surface) 21b of the rear end side concave portion 21B is set to a constant value along the circumferential direction of the cylindrical member 20 (Intervals of 45 degrees).

Each of the eight branch flow paths 25 is formed so as to be inclined outward (outside in the radial direction of the cross member 20) with respect to the axial direction of the cross member 20.

As a result, the surface of the leading end electrode having a certain size can be sufficiently aligned.

Here, the inclination angle of the branch passage 25 is preferably 3 to 45 degrees, more preferably 5 to 13 degrees, and a suitable example is 7 degrees.

The distal end portion (diameter reduction portion 211) of the first component 21 is provided with guide grooves 25a and 25b extending in the tip direction from each of the leg opening 25A successively to the eight branch flow paths 25, (Not shown).

The branch passage 25, the opening 25A for the pipe fitting and the guide groove 26 for the liquid are formed at intervals of 45 degrees along the outer circumference of the housing member 20, respectively, in the housing member 20 (first component 21) 8, but only a part thereof is shown in Fig. 7 showing the longitudinal section.

(Rear end face) 21b of the rear end side concave portion 21B to the tip side concave portion 21A is formed in the first part 21 as shown in Figs. 2, 6, 7, A center through hole 214 is formed along the central axis of the first component 21 so as to reach the bottom face (front end face 21a) of the first component 21.

The central through hole 214 of the first component 21 and the central through hole 224 of the second component 22 constitute a central through hole of the connecting member 20. [

As shown in Figs. 2, 4 to 7 and Figs. 10 to 13, the center tube 54 is inserted into the central through holes 214, 224 of the housing member 20. A lead wire 30L of the tip electrode 30 and a lead wire 35L of the temperature sensor are inserted through the center tube 54. [

8 to 12, the lead wire 40L of the ring-shaped electrode 40 (the first ring-shaped electrode from the tip end) is formed on the outer peripheral surface of the first component 21 (linear body portion 213) Are arranged at equal angular intervals (at intervals of 90 degrees) along the outer periphery of the straight body portion 213. In this case,

Here, the width of the receiving groove 215 is preferably 0.12 to 0.50 mm, and a suitable example is 0.34 mm.

Further, the depth of the receiving groove 215 is preferably 0.10 to 0.20 mm, and a preferable example is 0.12 mm.

One of the four receiving grooves 215 formed on the outer peripheral surface of the first component 21 (linear barrel portion 213) has a receiving groove 225 formed on the outer peripheral surface of the second component 22 (linear barrel portion 223) And the lead wires 40L of the ring-shaped electrodes 40 are accommodated in the receiving grooves 215 and the receiving grooves 225 of the second component 22. As shown in Fig.

10, the lead wire 40L of the first ring-shaped electrode 40 from the tip end is provided with a receiving groove 215 and a receiving groove 225 (the groove having a shallow portion 225a and an inclined portion 225b And the lumen 13 of the catheter shaft 10 and the lumen 13 of the catheter shaft 10 through the openings of the catheter shaft 10 and the lumen 13 of the catheter shaft 10, And is connected to a connector (not shown) connected to the inside of the control handle 70 or the proximal end side thereof through the inside of the control handle 70. The lead wire 40L of the second ring-shaped electrode 40 from the tip is connected to the opening of the lumen 13 of the catheter shaft 10 through the receiving groove 225 (shallow groove-deep groove portion 225c) Guidance.

(The receiving groove 215 in the first component 21 and the receiving groove 225 in the second component 22) of the lead wire 40L are formed on the outer peripheral surface of the cylindrical member 20, , It becomes possible to mount the ring-shaped electrode 40 on the outer peripheral surface (area) of the catheter shaft 10 in which the cap member is located.

As a result, the distance between the tip electrode 30 and the first ring-shaped electrode 40 from the tip end can be narrowed (for example, to about 2 mm), and desired potential measurement can be performed between these electrodes.

The first component 21 and the second component 22 constituting the cap member 20 include a molded product of an insulating resin or an insulating ceramic.

It is preferable that the first component 21 and the second component 22 include a molded body obtained by a ceramic injection molding method (CIM).

According to the ceramic injection molding method, a fine shape (for example, a fine shape having a thickness of about 60 탆) that can not be formed by injection molding with a resin can be formed. Therefore, (20) can be reliably molded.

In addition, the ceramic formed body obtained by the ceramic injection molding method has a low thermal conductivity suitable as a constituent material of the driving member.

The ceramics formed by the ceramic injection molding method is excellent in insulation property so that even when an edge is formed in the cap member 20 including the formed body, the current is concentrated in the edge portion when the ablation catheter 100 is used There is no high temperature.

As a suitable ceramic material constituting the cage member 20, zirconia is preferably used from the viewpoint of excellent moldability and excellent biocompatibility.

The cap member 20 is constituted by fitting the rear end side concave portion 21B formed in the first part 21 and the tip end small diameter portion 221 of the second part 22 to each other.

(Rear end face) 21b of the rear end side concave portion 21B of the first component 21 and the bottom face (rear end face) 21b of the front end face 22a of the second component 22 Is spaced apart by a distance of d ₂₁ -d ₂₂ and a jacket space defined by the inner circumferential surface of the rear end concave portion 21B and the outer circumferential surface of the central tube 54 is defined between the slots, And this reservoir space 24 serves as the liquid reservoir.

The reservoir space 24 formed in this manner is a space for causing the liquid from the eccentric flow paths 23 and 23 to merge and uniformly distribute the liquid in the circumferential direction of the cap member 20. Since there is no circumferential partition wall in the storage space 24, the liquid introduced into the storage space 24 can freely flow in the circumferential direction.

Here, the length (d ₂₁ -d ₂₂ ) of the retention space 24 is preferably 0.15 to 0.65 mm, and a suitable example is 0.30 mm.

The cap member 20 constructed as described above is provided with two eccentric flow channels 23 and 23 formed inside the second part 21 so as to communicate with the lumens 11 and 11 of the catheter shaft 10 to be a liquid channel And the first component 21 and the second component 21 are arranged in a space communicating with the eccentric flow paths 23 and 23 so that the liquid from the eccentric flow paths 23 and 23 is uniformly distributed in the circumferential direction of the cylindrical member 20. [ A liquid reservoir space 24 formed in a fitting portion of the valve body 22 and having no partition in the circumferential direction and a liquid reservoir space 24 communicating with the reservoir space 24 and extending in the tip direction while being inclined outward, Eight branch channels 25 are formed in the first part so as to reach each of the eight branch channels 25 and the distal end portions (The diameter-reduced portion 211 of the one component).

7, the straight body portion 213 and the second component 22 (the distal end small diameter portion 221 and the straight body portion 223 (see Fig. 7) of the first component 21 constituting the cage member 20 ) Of the catheter shaft 10 are inserted (fitted) into the tip side concave portion of the catheter shaft 10 and each of the eccentric flow channels 23 and 23 of the diaphragm member 20 is inserted through the joint tubes 51 and 51 (20) is connected to the distal end side of the catheter shaft (10) by communicating with the catheter shaft (11, 11).

Thus, only the diameter-reduced portion 211 and the large diameter portion 212 of the first component 21 are shown as the outer shape of the cross member 20.

On the other hand, the cylindrical portion 33 of the tip electrode 30 is fitted to the tip side concave portion 21A of the cap member 20 (the first component 21) And the front-end electrode 30 is connected.

The distal electrode 30 connected to the distal end side of the cap member 20 and constituting the ablation catheter 100 has a hemispherical distal end bulging portion 31 and a neck portion 32 and a cylindrical portion 33 .

The diameter of the tip swelling portion 31 of the tip electrode 30 is preferably 1.0 to 3.3 mm, more preferably 2.2 to 2.6 mm, particularly preferably 2.3 to 2.5 mm, and a suitable example is 2.36 mm.

It is preferable that the value of D1 / D2 is 1.0 or more when the diameter of the tip bulging portion 31 (the maximum diameter of the tip electrode 30) is D1 and the tube diameter of the catheter shaft 10 is D2, Preferably 1.0 to 1.5, and a suitable example is 1.0 (D1 / D2 = 2.36 mm / 2.36 mm).

When the value of D1 / D2 is too small, it is difficult to perform efficient cauterization treatment by the catheter having such a tip electrode.

On the other hand, when the value of D1 / D2 is too large, it becomes difficult to move a sufficient amount of liquid to the surface of such a tip electrode.

The reason why a sufficient amount of liquid can flow around the surface of the tip electrode 30 having a value of D1 / D2 of 1.0 or more is that the branching flow path 25 of the cap member 20 is inclined outward, This is because the gimbal opening 25A is located on the outer side as compared with the case. Also in this respect, it is significant to interpose the cross member 20.

A liquid guiding groove 36 continuous to each of the guide grooves 26 of the cap member 20 is formed at the proximal end portion (the neck portion 32) of the tip electrode 30. [

The guide groove 36 is formed to guide the liquid reaching the base end of the tip electrode 30 through the guide groove 26 formed in the cap member 20 to the tip of the tip electrode 30 The liquid can be supplied to the entire surface of the tip electrode 30 including the tip swelling portion 31. In this way,

Further, since the guide groove 36 formed in the tip electrode 30 has a gentle R shape, no abnormal temperature rise occurs at this portion even at the time of cauterization.

According to the ablation catheter 100 of this embodiment, since the leg opening 25A is formed in the insulating cap member 20 and the edge is not present in the conductive tip electrode 30, the ablation catheter 100, (High temperature part) is not generated in a part of the tip electrode 30 (when cauterization) is used (cauterization), and formation of blood clots due to blood contact with such high temperature part can be suppressed. Further, since there is no need to form an opening in the tip electrode 30, a sufficient surface area can be secured for cauterization, and efficient cauterization treatment can be performed.

According to the ablation catheter 100 of this embodiment, the liquid is jetted (co-located) from the eight coaxial openings 25A disposed at the tip end of the cap member 20 to the surface of the tip electrode 30, A sufficient amount of liquid can be brought into contact with the surface of the tip electrode 30.

The liquid sprayed onto the surface of the tip electrode 30 is directed from the proximal end portion (the neck portion 32) of the tip electrode 30 toward the tip end (bulge portion 31) along the surface of the tip electrode 30 Flows.

Therefore, the ablation catheter 100 is superior in the surface cooling effect of the front-end electrode 30 and in the periphery of the front-end electrode 30 as compared with a conventionally known catheter in which an opening for the cap is formed in the front- The blood is sufficiently stirred and diluted so that a better thrombus formation inhibitory effect is exerted.

Since the eight leg openings 25A are arranged at equal angular intervals (45 DEG) along the outer periphery of the cylindrical member 20, the surface of the front end electrode 30 extends over the entire circumference (360 DEG) It can be customized.

Two lumens 11 and 11 serving as liquid passages and two lumens 12 and 12 serving as insertion passages for the tension wires 61 and 62 are provided at the distal end flexible portion 10A of the catheter shaft 10, And the two lumens 13 and 13 serving as the insertion passages of the lead wire of the ring electrode 40 are all formed at eccentric positions. Therefore, the plate spring 65 can be disposed along the central axis at the distal end flexible portion 10A of the catheter shaft 10. [

The ablation catheter 100 in which the leaf spring 65 is disposed is provided with sufficient torsional rigidity at the distal end flexible portion 10A of the catheter shaft 10, thereby being excellent in operability.

In addition, a liquid storage space 24 having no partition in the circumferential direction is provided in the inside of the housing member 20, and a liquid storage space 24 communicating with the storage space and extending in the tip direction while being inclined outward, The liquid that has reached the storage space 24 through the eccentric flow paths 23 and 23 is uniformly distributed in the circumferential direction in the storage space 24, The amount of liquid supplied from the catheter shaft 10 to the diaphragm member 20 is changed in the circumferential direction due to the jetting from the diaphragm opening 25A through each of the eight branch channels 25, (Fluctuation in the circumferential direction due to the eccentric formation of the two lumens 11 and 11 serving as the liquid flow path due to the plate spring 65 disposed at the tip end flexible portion 10A) For eight gangways arranged at intervals of 45 ° It is possible to uniformly spray (circumference) in the circumferential direction of the cap member 20 without changing the amount of liquid sprayed between the spheres 25A, (360 DEG).

The rear end side concave portion 21B (the rear end shape of the first part) formed on the first part 21 and the front end small diameter portion 221 (the end shape of the second part) And the cylindrical portion 33 (the rear end shape of the front electrode) of the front end electrode 30 and the front end side recess 21A (the rear end shape of the front electrode) of the first component 21 The distal end electrode 30 can be connected to the distal end side of the cap member 20 by fitting the tip end of the first component.

By constituting the cap member 20 with two parts as described above, it is possible to avoid the problem of the undercut caused by the shape of the reservoir space 24, and the eccentric flow paths 23 and 23, the reservoir space 24, , It becomes possible to obtain the cap member 20 having eight branch passages 25 formed therein by molding.

Further, since each of the branch flow paths 25 formed in the interior of the cap member 20 (the first component 11) is inclined to the outside, the value of the tip electrode D1 / D2, which is somewhat large, The tip electrode 30).

Since the liquid guide grooves 26 extending in the front end direction are formed continuously to the respective branching flow paths 25 at the distal end portions of the cap member 20 (the first component 11) It is possible to reliably guide (guide) the liquid ejected from the liquid ejection head 25A toward the front-end electrode 30. [

Since the liquid guide grooves 36 continuous to the guide grooves 26 of the cap member 20 are formed on the base end surface of the tip end electrode 30, The liquid reaching the proximal end of the distal electrode 30 can be guided to the distal end of the distal electrode 30 through the distal end electrode 26 so that liquid can be supplied to the entire surface of the distal electrode 30. [

Although the embodiment of the present invention has been described above, the present invention is not limited thereto, and various modifications are possible.

For example, the number of branching channels (openings for legacy) in the cross member may not be eight, and may be appropriately selected in the range of 4 to 12, for example.

In addition, the number of lumens (the number of eccentric flow paths in the cross member) to be the liquid flow path of the catheter shaft may not be two, or may be one or three or more. However, the present invention is effective when a catheter shaft having a small number of lumens constituting a liquid flow path is used.

The inner structure of the catheter shaft is not particularly limited as long as the lumen to be the liquid channel is eccentrically formed at the distal end flexible portion.

The shape of the tip electrode is not particularly limited, and may be a shell shape or the like.

100: ablation catheter
10: catheter shaft
10A:
11: lumen (flow path of liquid)
12: lumen (insertion wire of tension wire)
13: Lumen (Insertion way of lead wire)
20:
21: First part
211: diameter reduction portion
212:
213: straight body portion
214: central through hole
215: Housing of the lead wire
21A: tip end concave portion
21a: a bottom surface (front end surface) of the tip side concave portion 21A
21B: rear end side concave portion
21b: a bottom surface (rear end surface) of the rear end concave portion 21B;
22: Second part
221: distal small neck
223: straight body portion
224: central through hole
225: Housing of lead wire
226: a housing groove of the distal end of the tension wire
22a: the distal end of the distal small diameter neck
23: Eccentric flow
231:
24: Storage space of the liquid
25: Branching Euro
25A: an opening for a pipe fitting
26: guide groove of the liquid
30: tip electrode
30L: lead wire of the tip electrode
31:
32: neck
33: cylindrical portion
35L: Lead wire of temperature sensor
36: guide groove of the liquid
40: ring-shaped electrode
40L: Lead wire of ring-shaped electrode
51: Joint tube
54: center tube
61: tensile wire
62: Tensile Wire
65: leaf spring
70: control handle
75: Spindle
80: Liquid injection tube

Claims (10)

A catheter shaft having a distal end flexible portion and at least one lumen to be a liquid flow path eccentrically formed at the distal end flexible portion; an insulating cap member connected to a distal end side of the catheter shaft; And an end electrode connected to the electrode,
Wherein the insulating cap member is provided with a plurality of capillary openings for conforming the liquid supplied from the catheter shaft to the surface of the tip electrode at equal angular intervals along the periphery of the insulating cap member,
At least one eccentric flow passage communicating with a lumen which becomes a liquid flow path of the catheter shaft,
A liquid reservoir space communicating with the eccentric flow path and having no partition in the circumferential direction so that liquid from the eccentric flow path is uniformly distributed in a circumferential direction of the insulating cap member;
A plurality of branch channels communicating with the storage space and extending in the tip direction while being inclined outward to reach each of the plurality of pipe fitting openings is formed,
The insulating cap member is composed of a first component having a tip shape that can be fitted to the shape of the rear end of the tip electrode and a second component having a tip shape fittable to the shape of the rear end of the first component,
The eccentric flow path is formed inside the second part,
The plurality of branch channels are formed in the first component,
Wherein the reservoir space is formed at a fitting portion between the first component and the second component. The liquid container according to any one of claims 1 to 3, wherein a leading end portion of the insulating cap member is formed with a liquid guide groove which is continuous to each of the plurality of branch paths and extends from each of the plurality of cap fitting openings in the tip direction,
Wherein a guiding groove of liquid continuous with each of the guide grooves of the insulating cap member is formed at the proximal end of the tip electrode. 3. The connector according to claim 1 or 2, wherein the insulating cap member is formed by fitting a rear end side concave portion formed on the first component and a small diameter portion on the tip side of the second component,
The depth of the rear end side concave portion of the first component is formed to be deeper than the length of the small diameter portion at the front end side of the second component so that in the fitting portion between the first component and the second component, Wherein the electrode catheter is formed in a cylindrical shape. The electrode catheter according to claim 1 or 2, wherein the first component and the second component constituting the insulating cap member are formed by a ceramic injection molding method (CIM). The electrode catheter of claim 1 or 2, further comprising a leaf spring extending along a central axis of the catheter shaft as a biasing mechanism for bending the distal flexible portion of the catheter shaft. 3. The electrode catheter according to claim 1 or 2, wherein the lumen to be a liquid channel of the catheter shaft and the eccentric channel of the insulating cap member are communicated through the joint tube. 3. The electrode catheter according to claim 1 or 2, wherein the number of eccentric flow paths formed in the insulative cylindrical member is 1 or 2, and the number of branch flow paths is 4 or more. 3. The connector according to claim 1 or 2, wherein the insulating cap member is formed with a central through hole along a central axis thereof, a center tube is inserted through the central through hole,
Wherein the liquid storage space is a jacket space defined by an inner circumferential surface of the rear end side concave portion of the first component and an outer circumferential surface of the center tube. The electrode catheter according to claim 8, wherein at least one of a lead wire of the tip electrode and a lead wire of the temperature sensor is inserted into the center tube. 3. The catheter according to claim 1 or 2, wherein the tip end of the tip electrode is bulged and the maximum diameter of the tip electrode is D1 and the tube diameter of the catheter shaft is D2, Characterized by an electrode catheter.

Images