TW201404422A - Electrode catheter - Google Patents

Abstract

An electrode catheter is provided with: a catheter shaft (10); an operating handle (20) provided with a connector (70); a tip electrode (31); ring-shaped electrodes (32-34); lead wires (41-44) connected to the tip electrode (31) and the ring-shaped electrodes (32-34), respectively; and a pull wire (50) affixed to the tip electrode (31). The catheter shaft (10) comprises: a shaft proximal end section (11) comprising a metallic tube; a shaft distal end section (12) comprising a resinous tube; and a resinous coating layer (13) for covering the outer peripheries of both the shaft proximal end section (11) and the shaft distal end section (12). A lead wire protective tube (61) which comprises a soft tube and a wire protective tube (62) which comprises a soft tube are inserted in the shaft proximal end section (11). In the electrode catheter, the lead wires extending from the shaft proximal end section into the operating handle are not damaged or broken by coming into contact with the edge of the opening end of the shaft proximal end section.

Description

Lead

The present invention relates to an electrode catheter.

The use of a lead as a medical device to diagnose or treat arrhythmia of the heart is a well-known person.

As an electrode catheter for measuring the potential of a pulmonary vein or the like of the heart, the applicant has proposed an electrode catheter having a catheter tube shaft, an operation handle connected to the proximal end side of the catheter tube shaft, and a front end side connected to the catheter tube shaft. a catheter tip end portion formed into a circular loop shape; a plurality of ring shape electrodes attached to the outer periphery of the catheter tip end portion; and a distal end electrode attached to the front end of the catheter tip end portion (refer to Patent Document 1).

The catheter tube shaft (catheter body) constituting the electrode catheter described in Patent Document 1 is a single-chamber structure (elongated tubular structure having one inner hole), and has a resin sleeve (first sleeve) having a relatively high rigidity. And a soft resin sleeve (second sleeve) with relatively low rigidity.

Here, the preferred outer diameter of the catheter tube shaft is set to 2.3 to 2.4 mm (refer to [0021]-[0025] of Patent Document 1.

However, for example, a plurality of (for example, 2 to 3) lead electrodes are inserted into the inside of the heart through a sheath, and when the intracardiac potentials of the plurality of portions are measured, the outer diameters of the catheter tube shafts constituting the electrode catheters are It is preferable that the outer diameter of the patent document 1 is preferably small (for example, 1.4 mm or less).

In addition, in order to select the direction of the blood vessel to the target site, or to press the electrode to the target site, it is necessary to greatly bend the front end portion of the catheter tube shaft. Therefore, the catheter tube shaft constituting the electrode catheter is required to have a good anti-nucleus. Kink Resistance or Torque Communication. Also, the catheter tube shaft also requires good extrusion characteristics.

However, the above-mentioned small outer diameter catheter tube shaft is low in rigidity and does not have good antiknocking property and torque transmission property. Moreover, the catheter tube shaft having a small outer diameter has poor extrusion characteristics.

In addition, in the following Patent Document 2, an electrode catheter having a tubular shaft end portion (a proximal portion of a tube axis) is formed by a stainless steel hypotube coated with Teflon (registered trademark).

By constructing the base end of the tube shaft by means of a hypotube, a good catheter tube shaft with anti-knot resistance, torque transmission and extrusion characteristics can be realized.

[Advanced technical literature] [Patent Literature]

[Patent Document 1] JP-A-2008-245767

[Patent Document 2] JP-A-2009-142640

(1) However, when the base end portion of the tube shaft of the lead conduit is formed of a metal sleeve such as a hypotube, the lead wire or the wire extending from the proximal end side opening of the catheter tube shaft (the opening of the base end portion of the tube shaft) is based on Contact (interference) with the edge of the opening edge of the base end of the tube shaft may cause damage or disconnection.

The damage of the lead wire or the wire caused by the contact with the edge (edge portion) of the opening does not occur when the material of the base end portion of the tube is resin. This problem is caused by the use of metal as the constituent material of the end portion of the tube shaft. Newly generated problems.

(2) At the time of manufacture of the lead electrode (the operation of attaching the operation handle to the catheter tube shaft), the base end portion of the tube shaft of the catheter tube shaft in which a plurality of lead wires are extended is inserted into the inside of the operation handle, and The tube shaft base end and the operating handle are fixed by an adhesive.

However, in this work, the adhesive for the base end portion of the tube shaft and the operating handle is attached to the lead extending from the opening of the base end portion of the tube shaft.

At this time, the lead wires are fixed to the base end portion of the tube shaft and cannot move in the axial direction. Thus, for example, when the front end of the catheter tube shaft is to be deflected, the lead wire is broken by the tensile force acting on the lead wire.

In addition, the adhesive for the base end portion of the tube shaft and the operating handle is attached to the tension wire extending from the opening of the base end portion of the tube shaft (the front end of the catheter tube shaft is biased toward the wire for operation) The extension wire is fixed to the base end of the tube shaft and cannot move in the axial direction. As a result, the catheter cannot be made. The front end of the tube shaft is biased to operate.

The present invention has been made in view of the above. SUMMARY OF THE INVENTION An object of the present invention is to provide an electrode catheter which has good operability of a catheter even when its outer diameter is small, has good kink resistance, torque transmission property and extrusion property as an electrode catheter, and is provided by a base end portion of the tube shaft. The lead extending to the inside of the operating handle does not come into contact with the edge of the opening edge of the base end portion of the tube shaft to cause damage or breakage.

Another object of the present invention is to provide an electrode catheter in which the adhesive for the base end portion of the tube shaft and the operating handle is not attached to the lead extending from the base end portion of the tube shaft in the manufacturing process, thereby ensuring The movement of the lead relative to the base end of the tube shaft in the direction of the axis.

Still another object of the present invention is to provide an electrode catheter for preventing a wire which is biased toward a front end of a catheter tube shaft from coming into contact with an edge of an opening edge of a base end portion of the tube shaft, thereby causing damage and disconnection. The front end is biased towards operation.

Still another object of the present invention is to provide an electrode catheter in which the adhesive for the base end portion of the tube shaft and the operating handle is not attached to the lead wire which biases the front end of the catheter tube shaft in the manufacturing process, thereby ensuring The movement of the wire in the axial direction with respect to the base end portion of the tube shaft (stretching operation) allows the front end biasing operation.

(1) An electrode catheter according to the present invention, comprising: a catheter tube shaft, a tube shaft base end portion formed of a metal sleeve, and a resin sleeve The front end of the tube shaft is connected; the operating handle is connected to the proximal end side of the catheter tube shaft; the connector is attached to the operating handle; the front end electrode is attached to the front end of the catheter tube shaft; The front end is connected to the front end electrode, extends inside the catheter tube axis in the axial direction to reach the inside of the operation handle, and has a rear end connected to the connector; and a lead wire whose front end is fixed to the front end electrode Or the front end portion of the catheter tube shaft extends in the axial direction inside the catheter tube shaft, and the rear end thereof is fixed to the operation handle or the base end portion of the catheter tube shaft; and the lead protection sleeve is The base end portion is inserted into the inner end portion of the tube shaft, and the base end portion thereof is formed by a soft sleeve extending from the opening of the base end portion of the tube shaft to the inside of the operation handle, and the lead wire is inserted into the inside.

According to the electrode catheter of this configuration, the base end portion of the tube shaft is composed of a metal sleeve, and the catheter tube shaft can have better anti-knot resistance, torsion transmission and extrusion as compared with a catheter tube shaft composed only of a resin sleeve. The pressure characteristics, the operability of the catheter can be improved.

Moreover, the lead protection sleeve formed by the soft sleeve is inserted into the inner end portion of the tube shaft, and the base end portion of the lead protection sleeve extends from the opening of the base end portion of the tube shaft to the inside of the operation handle, so The lead wire (lead of the front end electrode) passing through the inside of the lead protection sleeve can be extended from the opening of the lead protection sleeve to the inside of the operating handle without contacting the opening edge of the base end of the tube shaft, the lead Will not be damaged or broken.

(2) The electrode catheter of the present invention preferably includes at least one annular electrode attached to the front end portion of the catheter tube shaft; a plurality of leads, wherein the respective front ends are connected to the front end electrodes and the ring electrodes, and extend inside the catheter tube axis in the axial direction to reach the inside of the operation handle, and the individual rear ends are connected to the connection And a lead protection sleeve installed by being inserted into the inner end of the base end of the tube shaft, the base end portion of which is formed by a soft sleeve extending from the opening of the base end portion of the tube shaft to the inside of the operating handle The internal plug-in has the above plurality of leads.

According to the electrode catheter of this configuration, a plurality of leads (lead electrodes of the front end electrode and the ring electrode) inserted through the lead protection sleeve can be provided by the lead protective cover without being in contact with the opening edge of the base end portion of the tube shaft The opening of the tube extends toward the inside of the operating handle, and the leads are not damaged or broken.

(3) In the electrode catheter of the present invention, preferably, the front end of the catheter tube shaft is biased by performing a stretching operation on the rear end of the wire, and the wire protection sleeve is inserted through the base end of the tube shaft. The inside of the portion is mounted, and the base end portion thereof is constituted by a soft sleeve extending from the opening of the base end portion of the tube shaft to the inside of the operation handle, and the lead wire (stretched wire) is inserted into the inside.

According to the electrode catheter of this configuration, the wire protection sleeve formed by the soft sleeve is inserted into the inner end portion of the tube shaft, and the base end portion of the wire protection sleeve is from the opening of the base end portion of the tube shaft to the inside of the operation handle Extending out, so that the wire inserted through the wire protection sleeve can extend from the opening of the wire protection sleeve to the inside of the operating handle without contacting the opening edge of the base end of the tube shaft, the wire will not Damage or disconnection.

(4) The lead electrode according to (3) above, wherein the lead wire protection sleeve and the wire protection sleeve are fixed (positional fixing) via a connection member that connects the base end portion of the tube shaft and the operation handle. ) at the base end of the above tube shaft.

According to the electrode catheter of this configuration, in the manufacturing process, when the base end portion of the tube shaft and the connecting member are fixed, the protective sleeve (the lead protection sleeve and the wire protection sleeve) can be fixed to the tube shaft via the connecting member. Base end.

(5) In the electrode catheter of the present invention, the rear end of the lead wire extending from the opening of the base end portion of the tube shaft is fixed to the outer peripheral side of the base end portion of the tube shaft, and the base end of the lead protection sleeve is The portion is followed by the operation handle for fixing the base end portion of the tube shaft such that the lead protection sleeve is fixed to the tube shaft base end portion.

According to the lead pipe, the rear end of the wire extending from the opening of the base end portion of the pipe shaft is fixed to the outer peripheral side of the base end portion of the pipe shaft, so that the edge of the opening edge of the base end portion of the pipe shaft is in contact with it. There is no friction between the wires, and the wires will not be damaged or broken even if the wires are not protected by a soft sleeve.

Further, by fixing the base end portion of the lead protection sleeve to the fixing operation handle of the base end portion of the tube shaft, the tube shaft base end portion and the lead protection sleeve can be fixed via the operation handle.

(6) In the electrode catheter according to (1) or (2) above, preferably, the lead protection sleeve is made of a polyimide sleeve.

(7) The biasing operation before the above (3) or (4) may be Preferably, the lead electrode protection sleeve and the wire protection sleeve are made of a polyimide sleeve.

(8) In the electrode catheter of the present invention, it is preferable that at least a tip end portion of the metal sleeve constituting the base end portion of the tube shaft forms a spiral slit.

(9) In the electrode catheter of the present invention, it is preferred that the above-mentioned resin sleeve has a multi-chamber structure.

(10) In the electrode catheter of the present invention, it is preferred that the outer diameter of the catheter tube shaft is 1.4 mm or less.

The electrode catheter including the small outer diameter catheter tube shaft is particularly effective in the configuration of the catheter tube shaft of the present invention (the connection structure between the tube shaft base end portion of the metal sleeve and the resin shaft sleeve end portion).

According to the electrode catheter of the present invention, even if the outer diameter of the catheter tube shaft constituting the catheter is small, the catheter tube shaft has good kink resistance, torque transmission property and extrusion property, and has good operability of the catheter.

Further, according to the electrode catheter of the present invention, the lead wire which reaches the inside of the operation handle from the inside of the catheter tube shaft does not contact the edge portion of the opening edge of the base end portion of the tube shaft to cause damage or breakage.

In addition, in this manufacturing process, the adhesive for the base end portion of the tube shaft and the operating handle does not adhere to the lead extending from the lead protective sleeve, and the movement of the lead to the axial direction of the base end portion of the tube shaft can be ensured. .

Further, according to the electrode catheter of the above (3), it is further desired When the front end of the catheter tube shaft is deflected, the wire from the inside of the catheter tube shaft to the inside of the operation handle does not contact the edge of the opening edge of the base end portion of the tube shaft to cause damage or breakage.

Moreover, in the manufacturing process, the adhesive for the base end portion of the tube shaft and the operating handle does not adhere to the wire extending from the wire protection sleeve, and the axial direction of the wire end portion of the tube shaft can be ensured. Move (stretch operation).

100‧‧‧ lead

10‧‧‧ catheter tube shaft

11‧‧‧The base end of the tube shaft

110‧‧‧Metal casing

115‧‧‧ gap

12‧‧‧Tube front end

120‧‧‧Resin casing

121‧‧‧1st multi-lumen casing

122‧‧‧2nd multi-lumen cannula

1231, 1241‧‧‧1 cavity

1232, 1242‧‧‧2nd cavity

1233, 1243‧‧‧3rd cavity

1234, 1244‧‧‧4th cavity

125,126‧‧‧Multi-cavity casing constitutive resin

13‧‧‧ resin cover

130‧‧‧Heat-shrinkable resin sleeve

20‧‧‧Operation handle

21‧‧‧Handle body

22‧‧‧ knob

23‧‧‧ rotating plate

31‧‧‧ front electrode

32~34‧‧‧Ring electrode

41~44‧‧‧Leader

23‧‧‧ rotating plate

50‧‧‧Stretched wire

61‧‧‧Lead protection sleeve

62‧‧‧Wire protection sleeve

70‧‧‧Connector

80‧‧‧Connecting components

90‧‧‧Adhesive

150‧‧‧ lead

15‧‧‧ catheter tube shaft

16‧‧‧The end of the tube shaft

165‧‧ ‧ gap

17‧‧‧Tail shaft front end

171‧‧‧1st multi-lumen cannula

172‧‧‧2nd multi-lumen cannula

1731‧‧‧1st cavity

1732‧‧‧2nd cavity

1733‧‧‧3rd cavity

1734‧‧‧4th cavity

175‧‧‧Multi-cavity casing constitutive resin

18‧‧‧ resin cover

19‧‧‧ resin cover

25‧‧‧Operation handle

35~38‧‧‧Ring electrode

45~48‧‧‧ lead

55‧‧‧core wire

65‧‧‧Lead protection sleeve

75‧‧‧Connector

95‧‧‧ adhesive layer

Fig. 1 is a longitudinal sectional view (a partial plan view) showing an electrode catheter according to an embodiment of the present invention.

Fig. 2 is a longitudinal sectional view showing a proximal end portion of a tube shaft constituting a catheter tube shaft of the electrode catheter of Fig. 1 (a detailed sectional view of a portion A in Fig. 1).

Fig. 3 is a longitudinal cross-sectional view showing a connecting portion between a base end portion of a tube shaft constituting the catheter tube of Fig. 1 and a distal end portion of the tube shaft (a detailed sectional view of a portion B in Fig. 1).

Fig. 4 is a longitudinal sectional view showing a distal end portion of a tube shaft constituting a catheter tube shaft of the electrode catheter of Fig. 1 (a detailed sectional view of a portion C in Fig. 1).

Fig. 5 is a cross-sectional view (cross-sectional view taken along line D-D) showing the base end portion of the tube shaft of Fig. 2;

Fig. 6 is a cross-sectional view (cross-sectional view taken along line E-E) showing the joint portion of Fig. 3;

Fig. 7 is a cross-sectional view showing the front end portion of the tube shaft of Fig. 4 (F-F section) Figure).

Fig. 8 is a longitudinal sectional view showing an important part (a connecting portion of a catheter tube shaft and an operation handle) of the electrode catheter of Fig. 1.

Fig. 9 is a perspective view showing a state in which a protective sleeve is extended from a proximal end portion of a tube shaft of the electrode catheter of Fig. 1.

Fig. 10 is a longitudinal sectional view showing the method of manufacturing the electrode catheter of Fig. 1;

Fig. 11 is a longitudinal sectional view showing the method of manufacturing the electrode catheter of Fig. 1.

Fig. 12 is a longitudinal sectional view (partial plan view) showing an electrode catheter according to another embodiment of the present invention.

Fig. 13 is a longitudinal sectional view showing a proximal end portion of a tube shaft constituting a catheter tube shaft of the electrode catheter of Fig. 12 (a detailed sectional view of a portion G in Fig. 12).

Fig. 14 is a longitudinal sectional view showing a connecting portion between a proximal end portion of a tube shaft constituting the catheter tube shaft of the electrode catheter of Fig. 12 and a distal end portion of the tube shaft (a detailed sectional view of a portion H in Fig. 12).

Fig. 15 is a cross-sectional view (cross-sectional view taken along line I-I) showing the joint portion of Fig. 14;

Fig. 16 is a longitudinal sectional view showing an important part (a connecting portion of a catheter tube shaft and an operation handle) of the electrode catheter of Fig. 12;

Fig. 17 is a perspective view showing a state in which a protective sleeve and a lead wire are extended from a proximal end portion of a tube shaft of the electrode catheter of Fig. 12;

<First embodiment>

The electrode catheter 100 of this embodiment shown in Figs. 1 to 9 is used for a potential measurement in a portion such as a pulmonary vein of the heart.

The lead electrode 100 includes a catheter tube shaft 10, an operation handle 20 connected to a proximal end side of the catheter tube shaft 10, a connector 70 attached to the inside of the operation handle 20, and a front end mounted to the catheter tube shaft 10. a front end electrode 31; three annular electrodes 32, 33, 34 mounted on the outer circumference of the front end portion of the catheter tube shaft 10; four lead wires 41, 42, 43, 44 whose respective front ends are connected to the front end electrode 31 and each The annular electrodes 32, 33, 34 extend in the axial direction inside the catheter tube shaft 10 to reach the inside of the operating handle 20, the individual rear ends are connected to the connector 70; and the tensile lead 50 has a front end fixed to the front end electrode 31, extending inside the catheter tube shaft 10 in the axial direction to reach the inside of the operating handle 20, the rear end of which is fixed to the rotating plate 23 of the operating handle 20; the catheter tube shaft 10 constituting the electrode catheter 100 is composed of the following a front end portion is formed with a spiral slit 115, a tube shaft base end portion 11 composed of a metal sleeve, a tube shaft front end portion 12, and a rear end portion of the rear end portion thereof is inserted into the front end portion of the front end portion of the tube shaft base end portion 11. Inside the area, connected to the tube The base end portion 11 is composed of a multi-cavity resin sleeve (the first multi-cavity sleeve 121 and the second multi-lumen sleeve 122); and a resin coating layer 13 covering the tube shaft base end portion 11 and the tube shaft front end The outer circumference of the rear end portion of the portion 12; the lead wire 41, the lead wires 42, 43, 44, and the tensile lead wires 50 extend in different cavities of the resin sleeve constituting the front end portion 12 of the tube shaft.

Further, the lead electrode 100 is mounted by being inserted into the inside of the tube shaft base end portion 11, which is extended from the opening of the base end portion 11 of the tube shaft to the inside of the operating handle 20. The soft sleeve is configured to have a lead protection sleeve 61 through which the leads 41, 42, 43, 44 are inserted, and a wire protection sleeve 62 which is mounted by being inserted into the inside of the base end portion 11 of the tube shaft The base end portion 621 is formed of a soft sleeve extending from the opening of the tube shaft base end portion 11 toward the inside of the operation handle 20, and a tensile lead 50 is inserted therein.

The catheter tube shaft 10 constituting the electrode catheter 100 is composed of a tube shaft base end portion 11, a tube shaft tip end portion 12, and a resin coating layer 13.

The length (L ₁₀ ) of the catheter tube shaft 10 is usually set to 400 to 1500 mm, preferably 600 to 1200 mm, and preferably one example is, for example, 1000 mm.

The catheter tube shaft 10 is preferably set to have an outer diameter of 1.4 mm or less, preferably one example of which is, for example, 0.65 mm. Since the catheter tube shaft having such a small outer diameter does not have sufficient rigidity when formed only of a resin sleeve, the configuration of the tube shaft of the present embodiment is particularly effective.

The inner diameter of the catheter tube shaft 10 is preferably set to 1 mm or less, and preferably one example is, for example, 0.55 mm.

As shown in Fig. 1, Fig. 2, Fig. 3, Fig. 5 and Fig. 6, the tube shaft base end portion 11 of the catheter tube shaft 10 is a metal sleeve (hypotube) in which a spiral slit 115 is formed at the front end portion. .

The metal sleeve constituting the base end portion 11 of the tube shaft has a single-chamber configuration, and the metal constituting the base end portion 11 of the tube shaft may be stainless steel, NiTi, β-titanium or the like.

a tube base end portion 11 formed of a metal sleeve, and a resin sleeve When the tube is constructed, it has a very high rigidity, and even if the outer diameter of the tube shaft is small, it has good kink resistance, torque transmission property and extrusion property.

A spiral slit 115 is formed at a front end portion of the metal sleeve of the base end portion 11 of the tube shaft. This slit 115 is a through slit which reaches the inner peripheral surface from the outer peripheral surface of the metal sleeve, and therefore. As will be described later, at the time of manufacture of the electrode catheter 100, the width of the slit 115 can be expanded in the axial direction of the tube axis, and the outer diameter of the portion where the slit 115 is formed can also be enlarged.

By the formation of the spiral slit 115, the rigidity of the metal sleeve in the forming portion is somewhat lowered to impart flexibility, so that the inherent rigidity of the metal sleeve can be formed (good resistance) The knot and the extrusion characteristics), and the flexible shaft end portion 11 of the front end portion.

At the end portion of the metal sleeve constituting the base end portion 11 of the tube shaft, the distance between the spiral slits 115 is formed to be continuously narrowed toward the front end direction.

In this way, the rigidity of the front end portion of the base end portion 11 of the tube shaft can be continuously (smoothly) lowered toward the front end direction, and a particularly good anti-knotted catheter tube shaft 10 can be constructed.

The length (L ₁₁ ) of the tube shaft base end portion 11 is usually set to 300 to 1000 mm, preferably 400 to 950 mm, and preferably one example is, for example, 880 mm.

The length (L ₁₁₅ ) of the front end portion of the metal sleeve in which the spiral slit 115 is formed is usually set to 40 to 200 mm, preferably 50 to 160 mm, and preferably one example is, for example, 130 mm.

The width of the slit 115 in the base end portion 11 of the tube shaft (the portion not connected to the tip end portion 12 of the tube shaft) (indicated by (W ₀ ) in FIGS. 2 and 3) is usually set to 0.005 to 0.100 mm, preferably one example. For example, 0.01 mm.

The method of forming the slit 115 in the metal sleeve is not particularly limited, and laser processing, electric discharge machining, chemical etching, cutting processing, or the like can be employed.

As shown in Fig. 1, Fig. 3, Fig. 4, Fig. 6, and Fig. 7, the tube shaft distal end portion 12 of the catheter tube shaft 10 is formed of an insulating resin sleeve having a multi-cavity structure.

The resin sleeve constituting the tip end portion 12 of the tube shaft is formed by welding two multi-cavity sleeves (the first multi-lumen sleeve 121 and the second multi-lumen sleeve 122) having different hardnesses.

Further, in the present invention, the front end portion of the tube shaft may be formed of three or more multi-cavity sleeves having different hardnesses.

As shown in FIG. 6, four cavities (a first cavity 1231, a second cavity 1232, a third cavity 1233, and a fourth cavity 1234) are formed in the first multi-lumen sleeve 121 constituting the rear end portion of the tube shaft distal end portion 12. ). In the figure, the 125 system partitions the cavities 1231 to 1234 to constitute the resin of the first multi-lumen sleeve 121.

As shown in FIG. 7, four cavities (a first cavity 1241, a second cavity 1242, a third cavity 1243, and a fourth cavity 1244) are formed in the second multi-lumen sleeve 122 constituting the front end portion of the tube shaft distal end portion 12. ). In the figure, 126 is a resin that partitions the cavities 1241 to 1244 to form the second multi-lumen sleeve 122.

Forming a resin sleeve (first multi-lumen sleeve 121, second multi-cavity The resin (resin 125, resin 126) of the sleeve 122) may be a polyether block amide copolymer resin (PEBAX (registered trademark)).

As shown in FIGS. 6 and 7, the first multi-lumen cannula 121 and the second multi-lumen cannula 122 have the same multi-cavity structure (cross-sectional shape). In other words, each of the first cavity 1231, the second cavity 1232, the third cavity 1233, and the fourth cavity 1234 formed in the first multi-lumen cannula 121 is formed in the first cavity of the second multi-lumen cannula 122. 1241, each of the second cavity 1242, the third cavity 1243, and the fourth cavity 1244 are in communication.

The constituent resin 125 of the first multi-lumen sleeve 121 has a higher hardness than the constituent resin 126 of the second multi-lumen sleeve 122.

Here, the hardness of the resin 125 (calculated by a D-type hardness meter) is set to 55D to 72D, and preferably one example is 68D. Further, the hardness of the resin 126 is set to 25D to 50D, and preferably one example is, for example, 40D.

The length (L ₁₂ ) of the pipe shaft front end portion 12 is usually set to 30 to 300 mm, preferably 50 to 200 mm, and preferably one example is, for example, 120 mm.

Further, the length (L ₁₂₁ ) of the first multi-lumen sleeve 121 is usually 15 to 150 mm, preferably 25 to 100 mm, and preferably one example is 60 mm.

Further, the length (L ₁₂₂ ) of the second multi-lumen sleeve 122 is usually set to 15 to 150 mm, preferably 25 to 100 mm, and preferably one example is, for example, 60 mm.

For example, the resin sleeve constituting the front end portion 12 of the tube shaft is compared with the resin sleeve of the single chamber structure, and the resin sleeve of the multi-chamber structure constitutes the sleeve. The proportion of resin is higher. Here, the resin (resin 125) constituting the resin sleeve (the first multi-lumen sleeve 121 and the second multi-lumen sleeve 122) in the cross-sectional view of the tube shaft distal end portion 12 shown in FIGS. 6 and 7 The area ratio of the resin 126) is preferably 60% or more, and preferably one example is, for example, 66%.

In this manner, the tube end portion 12 having extremely high rigidity can be formed in accordance with the resin sleeve having a multi-cavity structure having a high proportion of resin.

Further, by using the multi-chamber structure, the rigidity of the pipe shaft front end portion 12 (resin sleeve) can be increased, and the rigidity of the tube shaft base end portion 11 (metal sleeve) can be made to some extent by the formation of the slit 115. If the inner tube end portion 11 and the tube shaft front end portion 12 are made of mutually different materials, the rigidity of the catheter tube shaft 10 between the two will not be extremely changed, and the rigidity may be toward the front end. The direction changes smoothly (lower).

In this way, when the front end portion of the catheter tube shaft 100 is bent, it is possible to effectively prevent the stress from being concentrated on the kink between the tube shaft base end portion 11 and the tube shaft front end portion 12.

As shown in Fig. 3, the tube shaft front end portion 12 and the tube shaft base end portion 11 are inserted (fitted) by the rear end portion of the former rear end portion (the first multi-chamber sleeve 121). Connected inside the front end area.

Inside the front end region of the front end portion of the pipe shaft base end portion 11, the rear end portion of the rear end portion of the pipe shaft front end portion 12 is inserted to join the two, and thus, the front end portion of the pipe shaft base end portion 11 is formed. Seam The width of the gap 115 is easily enlarged at the joint portion (the front end portion of the front end portion).

As shown in Fig. 3, the width (W ₁ ) of the slit 115 of the tube shaft base end portion 11 in the joint portion of the tube shaft front end portion 12 (the first multi-chamber sleeve 121) is compared with the portion of the non-joining portion. The width (W ₀ ) of the slit 115 of the base end portion 11 of the tube shaft actually becomes large.

Here, the width (W ₁ ) of the slit 115 in the joint portion is preferably 1.3 times or more the width (W ₀ ) of the slit 115 in the portion of the non-joining portion, and preferably one example is, for example, 5.0 times.

As described above, the width (W ₁ ) of the slit 115 of the tube shaft base end portion 11 in the joint portion of the tube shaft front end portion 12 is smaller than the width (W ₀ ) of the slit 115 in the portion of the non-joining portion. When it is set to be extremely large, the rigidity of the joint portion can be set to be lower than the rigidity of the front end portion of the pipe base base end portion 11 (the portion where the width of the slit 115 is formed by the normal width (W ₀ )), and The rigidity of the shaft distal end portion 12 is high, that is, the connecting portion can be an intermediate rigid portion, and thus the catheter tube shaft 10 in which the rigidity of the entire tube axis is inclined downward toward the distal end direction can be formed.

Further, the width (W ₁ ) of the slit 115 of the tube shaft base end portion 11 in the joint portion of the tube shaft distal end portion 12 is set to be larger than the width (W ₀ ) of the slit 115 in the portion of the non-joining portion. As a result of the fact that the rigidity of the joint portion is sufficiently lowered, the knot between the joint portion and the front end portion 12 of the pipe shaft can be surely prevented.

Further, in the catheter tube shaft 10, the tube shaft front end portion 12 is formed. A part of the resin (the constituent resin 125 of the first multi-cavity sleeve 121) flows into the slit 115 in the joint portion of the tip end portion 12 of the tube shaft, and the resin 125 flowing into the slit 115 comes into contact with the resin coating layer 13 to be melted. Resin cover layer 13.

In this manner, the positioning effect (biting effect) of the constituent resin 125 based on the slit 115 of the tube shaft base end portion 11 and the tube shaft leading end portion 12 flowing into the slit 115 is further covered by the resin 125 and the resin flowing into the slit 115. The welding effect of the layer 13 allows the tube shaft base end portion 11 composed of a metal sleeve to be strongly joined to the tube shaft front end portion 12 composed of a resin sleeve.

However, there is a dilatation catheter used in percutaneous coronary angioplasty (PTCA), which has a tube shaft base end portion formed of a metal sleeve formed with a spiral slit, and a resin sleeve. The pipe shaft front end portion is a catheter tube shaft in which the front end portion of the pipe shaft base end portion is inserted (fitted) into the inside of the pipe shaft tip end portion.

An electrode catheter having a small outer diameter catheter tube shaft can be considered as a dilating catheter as described above, and a tube shaft base end portion formed by a metal sleeve having a spiral slit and a tube shaft formed of a resin sleeve The distal end portion is coupled (fitted) to constitute a catheter tube shaft.

According to this lead electrode, extremely high rigidity can be ensured at the base end portion of the tube shaft formed of the metal sleeve.

However, in such an electrode lead, the rigidity of the tip end portion of the tube shaft formed by the resin sleeve is still low, and the kink resistance or extrusion characteristics of the front end portion of the tube shaft cannot be improved.

In addition, when it is desired to form a catheter tube shaft having a good antiknocking property, it is important to change (reduce) the rigidity in an inclined manner toward the distal end direction. However, the tube base end portion of the tube sleeve and the resin sleeve are formed of a metal sleeve. Between the front end portions of the shaft, extreme changes in rigidity cause the stress at the time of bending to concentrate on it and easily kink.

Further, in the dilatation catheter, the distal end portion of the proximal end portion of the tube shaft is inserted into the inside of the distal end portion of the tube shaft, and the connecting portion between the proximal end portion of the tube shaft and the distal end portion of the tube shaft The fitting part) is the most rigid part.

According to this connection portion, not only the rigidity of the tube shaft cannot be inclinedly lowered toward the distal end direction, but also a knot can be easily generated between the connection portion and the tip end portion of the tube shaft (the portion of the non-connection portion).

Further, in the case of the above-described dilatation catheter, when the tube shaft base end portion composed of the metal sleeve and the tube shaft distal end portion formed of the resin sleeve constitute the catheter tube shaft, it is difficult for the metal sleeve and the resin sleeve to be joined with high strength.

As shown in FIGS. 2 and 3, the resin coating layer 13 constituting the catheter tube shaft 10 covers the outer periphery of the tube shaft base end portion 11 and the tube shaft distal end portion 12 at the rear end portion.

The resin coating layer 13 is formed on the outer circumference of the entire length of the tube shaft base end portion 11 and the outer circumference of the rear end portion of the tube shaft distal end portion 12 (the first multi-lumen sleeve 121).

The film thickness of the resin coating layer 13 is, for example, 5 to 50 μm, preferably 10 to 30 μm.

The resin coating layer 13 is the tube shaft base end portion 11 and the tube shaft front The rear end portion of the end portion 12 is formed by being contracted by a heat shrinkable resin sleeve while being inserted into the inside.

The heat-shrinkable resin sleeve for forming the resin coating layer 13 may be, for example, a polyether block phthalamide copolymer resin (PEBAX (registered trademark)).

By forming the resin coating layer 13 for covering the tube shaft base end portion 11 and the outer circumference of the rear end portion of the tube shaft front end portion 12, the catheter tube shaft 10 is configured such that the tube shaft 10 can be prevented from being used when the electrode tube 100 is used. At the same time as the metal of the base end portion 11 contacts the blood, the liquid tightness of the tube shaft base end portion 11 in which the slit 115 is formed can be ensured.

The heat-shrinkable resin sleeve forming the resin coating layer 13 is formed of a heat-shrinkable resin having a higher melting property than the resin constituting the tip end portion 12 of the tube shaft (resin 125 of the first multi-lumen sleeve 121). point.

In the method of manufacturing the electrode catheter (the formation of the resin coating layer), the heat-shrinkable resin sleeve (tube) in the state in which the tube shaft base end portion 11 and the tube shaft tip end portion 12 are inserted later. The shaft forming material is heated at a temperature equal to or higher than the melting point of the constituent resin (resin 125) of the resin sleeve of the pipe shaft tip end portion 12 and the melting point of the heat shrinkable resin is not full, so that the resin constitutive resin is formed. One of the (resin 125) is partially melted, and the molten resin flows into the slit 115 formed in the base end portion 11 of the tube shaft in the joint portion of the tip end portion 12 of the tube shaft.

As shown in Fig. 1, an operation handle 20 is connected to the proximal end side of the catheter tube shaft 10.

The operation handle 20 constituting the electrode catheter 100 is provided with a handle body 21 and a rotary plate 23 having a knob 22 inside the operation handle 20 A connector 70 is mounted.

A front end electrode 31 is fixed to the front end of the catheter tube shaft 10.

The constituent material of the distal end electrode 31 may be a metal having good thermal conductivity such as aluminum, copper, stainless steel, gold or platinum, and is preferably made of platinum or the like which has good contrast properties to X-rays.

The outer diameter of the distal end electrode 31 is not particularly limited, and is preferably set to be the same as the outer diameter of the catheter tube shaft 10.

Three annular electrodes 32, 33, 34 are mounted on the outer circumference of the front end portion of the catheter tube shaft 10.

The constituent material of the ring-shaped electrodes 32, 33, and 34 may be an exemplified metal of the configuration of the tip electrode 31.

The outer diameter of the annular electrodes 32, 33, and 34 is also not particularly limited, and is preferably set to be the same as the outer diameter of the catheter tube shaft 10.

Inside the catheter tube shaft 10, four leads 41, 42, 43, 44 extend in the axial direction, and the front ends of the four leads 41, 42, 43, and 44 are connected to the front end electrode 31 and the ring electrode. 32, 33, 34 each. Further, inside the catheter tube shaft 10, the tensile lead 50 whose distal end is connected to the inside of the distal end electrode 31 is extended in the axial direction.

As shown in FIGS. 6 and 7, the three lead wires 42, 43, and 44 connected to the respective annular electrodes 32, 33, and 34 are formed toward the resin sleeve (the first multi-lumen sleeve) constituting the distal end portion 12 of the tube shaft. The first cavity (cavity 1231 and cavity 1241) of 121 and the second multi-lumen cannula 122) extends.

The respective rear ends of the leads 42, 43, 44, as shown in FIG. 1, are connected to a connector 70 mounted inside the operating handle 20.

Further, the lead wire 41 connected to the distal end electrode 31 extends toward the third cavity (cavity 1233 and cavity 1243) of the resin sleeve constituting the tip end portion 12 of the tube shaft, and the rear end of the lead wire 41 and the lead wires 42, 43, 44 Also, the connector 70 is attached to the inside of the operating handle 20.

Further, the drawn lead wire 50 fixed to the distal end electrode 31 extends toward the fourth cavity (cavity 1234 and cavity 1244) of the resin sleeve constituting the distal end portion 12 of the tube shaft.

The front end of the drawn wire 50 is firmly fixed by the solder filled in the inside of the front end electrode 31.

Further, the rear end of the drawn wire 50 is fixed to the rotary plate 23 of the operation handle 20 as shown in FIG.

In this way, while the front end electrode 31 is prevented from falling off, etc., the tension wire 50 is stretched by the rotation operation of the rotary plate 23, and the front end portion (the pipe shaft front end portion 12) of the catheter tube shaft 10 can be bent. Tilt the front end (swing).

Here, the constituent material of the drawn wire 50 may be a metal material such as a stainless steel or a Ni-Ti superelastic alloy, or a high-strength non-conductive material.

Further, in this embodiment, the lead wire and the tensile lead wire are not extended to the second cavity (cavity 1232 and cavity 1242) of the tube shaft distal end portion 12.

As explained above, the three leads 42, 43, 44 extend in the first cavity (1231, 1241), the lead 41 extends in the third cavity (1233, 1243), and the drawn wire 50 extends in the fourth cavity (1234, 1244). Therefore, the front end portion 12 of the tube shaft can avoid interference (contact) between the lead wires 41, 42, 43, and 44 and the tensile lead wire 50.

In addition, the drawn lead wires 50 extending from the front end portion 12 of the tube shaft toward the different cavities and the leads 41, 42, 43, 44 are separated from each other inside the tube shaft base end portion 11 as shown in FIG. (put one's oar in).

As a result, when the front end of the electrode catheter 100 of this embodiment is biased, damage to the leads 41, 42, 43, 44 due to interference with the tensile wires 50 moving in the axial direction (e.g., abrasion) can be prevented. Or disconnected.

As shown in Fig. 8, at the front end of the operation handle 20, a hollow connecting member 80 composed of a base portion 81 having a conical trap shape and a cylindrical front end portion 82 is fixed.

The front end portion 82 of the connecting member 80 is inserted into the tube shaft base end portion 11 of the catheter tube shaft 10, and the tube shaft base end portion 11 (insertion portion) is filled with the adhesive 90 filled inside the front end portion 82. It is fixed to the connecting member 80.

In this manner, the operation handle 20 can be connected to the proximal end side of the catheter tube shaft 10 (the tube shaft base end portion 11).

As shown in FIGS. 8 and 9, the lead protection sleeve 61 and the wire protection sleeve 62 are inserted inside the tube shaft base end portion 11.

The lead protection sleeve 61 is composed of a soft sleeve, and the base end portion 611 of the lead protection sleeve 61 extends from the opening of the tube shaft base end portion 11 to the inside of the operation handle 20 (outside the tube shaft base end portion 11) Extend out.

Inside the lead protection sleeve 61, leads 41, 42, 43, 44 are inserted, and the leads 41, 42, 43, 44 are opened by the lead protection sleeve 61. The mouth extends to the inside of the operating handle 20 (outside of the lead protection sleeve 61).

The wire protection sleeve 62 is composed of a soft sleeve, and the base end portion 621 of the wire protection sleeve 62 extends from the opening of the tube shaft base end portion 11 to the inside of the operation handle 20 (outside the tube shaft base end portion 11) . A tensile wire 50 is inserted through the wire protection sleeve 62, and the tensile wire 50 extends from the opening of the wire protection sleeve 62 to the inside of the operating handle 20 (the outside of the wire protection sleeve 62).

Each of the lead protection sleeve 61 and the wire protection sleeve 62 is then fixed to (positionally fixed) the tube shaft base end portion 11 by a connecting member 80.

In this way, in the manufacturing process of the lead electrode 100, when the tube shaft base end portion 11 and the connecting member 80 are subsequently fixed, the tube shaft base end portion 11 and the lead protection sleeve 61 and the wire protective sleeve can be passed through the connecting member 80. The tube 62 is fixed.

The constituent materials of the lead protection sleeve 61 and the wire protection sleeve 62 may be a polyimide resin, a polyamide resin, a polyamide-imine resin, etc., among which the lead group is easily inserted. The possible polyimine resin for thin meat formation is particularly good.

The length of the lead protection sleeve 61 and the wire protection sleeve 62 is usually set to 5 to 500 mm, preferably 10 to 200 mm, and preferably one example is, for example, 30 mm.

Further, the length of the portion inserted into the inside of the base end portion 11 of the tube shaft is usually 10 to 400 mm, preferably 20 to 200 mm, preferably one example. For example 25mm.

The outer diameter of the lead protection sleeve 61 is preferably set to 0.24 to 0.50 mm, preferably one example is, for example, 0.32 mm. Further, the inner diameter thereof is preferably set to 0.20 to 0.46 mm, and preferably one example is, for example, 0.28 mm.

Further, the outer diameter of the wire protection sleeve 62 is preferably set to 0.16 to 0.28 mm, preferably one example is, for example, 0.22 mm. Further, the inner diameter is preferably set to 0.14 to 0.24 mm, and preferably one example is, for example, 0.18 mm.

The electrode catheter 100 of this embodiment is preferably produced by a method including the following items (1) to (5).

(1) As shown in Fig. 10 (Fig. 10A), a metal sleeve 110 in which a spiral slit 115 is formed at the tip end portion is prepared.

Here, as an example of the metal sleeve 110, for example, a stainless steel sleeve having an outer diameter (D ₀ ) of 0.65 mm, an inner diameter (d ₀ ) of 0.55 mm, and a slit 115 width (W ₀ ) of 0.01 mm can be used.

(2) As shown in Fig. 10 (Fig. 10B), the width of the slit 115 in the front end region is expanded while the front end region (the region near the opening) of the front end portion of the metal sleeve 110 is expanded.

Here, the length of the front end region where the diameter expansion is performed is set to about 4 mm.

The front end region of the expanded metal sleeve 110, for example, the outer diameter (D ₁ ) is 0.76 mm, the inner diameter (d ₁ ) is 0.66 mm, and the width of the slit 115 (W ₁ ) is 0.05 mm [(W ₁ /W). ₀ ) = 5).

(3) As shown in Fig. 11 (Fig. 11A), a resin sleeve having a multi-cavity structure is formed inside the front end region of the expanded metal sleeve 110. The rear end portion of the tube 120 is inserted to fit the metal sleeve 110 with the resin sleeve 120.

Here, the outer diameter of the rear end portion of the resin sleeve 120 is such that it can be inserted into the inner end region of the metal sleeve 110, and is not easily peeled off after insertion (for example, about 0.65 mm). The rear end portion of the resin sleeve 120 may be subjected to cutting processing as necessary to become the outer diameter.

(4) As shown in Fig. 11 (Fig. 11B), the fitting metal sleeve 110 and the rear end portion of the resin sleeve 120 are inserted into the inside of the heat-shrinkable resin sleeve 130.

Here, the metal sleeve 110 is inserted into the inside of the heat-shrinkable resin sleeve 130.

(5) The tube shaft forming material in the state shown in Fig. 11B is carried out at a temperature higher than the melting point of the resin constituting the resin sleeve 120 and less than the melting point of the heat-shrinkable resin constituting the heat-shrinkable resin sleeve 130. Heating causes the heat-shrinkable resin sleeve 130 to contract.

By the contraction of the heat-shrinkable resin sleeve 130, the front end region of the metal sleeve 110 (the fitting portion of the metal sleeve 110 and the resin sleeve 120) is crimped, and the front end region of the metal sleeve 110 is tapered. At the same level as the outer diameter (D ₀ ) before the diameter expansion, the metal sleeve 110 and the resin sleeve 120 are joined together, and the resin coating layer formed by shrinking the heat-shrinkable resin sleeve 130 is formed in the metal sleeve. The outer circumference of 110 and the outer end portion of the rear end portion of the resin sleeve 120.

At this time, in the fitting portion of the metal sleeve 110 and the resin sleeve 120, a part of the constituent resin of the resin sleeve 120 is melted and flows in. The expanded slit 115 in the metal sleeve 110 and the resin in the molten state flowing into the slit 115 are in contact with the inner peripheral surface of the contracted heat-shrinkable resin sleeve 130 to be dissolved therein. In this way, the above-mentioned fixed aiming effect (biting effect) and the melting effect can be exerted.

Further, the slit 115 in the front end region of the metal sleeve 110 (and the joint portion of the resin sleeve 120) is maintained by the inflow of the resin constituting the resin sleeve 120 by the above-mentioned work (2) ( W ₁ ).

According to the above construction, the catheter tube shaft 10 having the joint portion shown in Fig. 3, that is, the tube shaft base end portion 11 composed of the metal sleeve (110), and the tube shaft front end portion 12 composed of the resin sleeve (120) are provided. The inside end region of the front end portion of the pipe shaft base end portion 11 is connected by the insertion of the rear end portion of the rear end portion of the pipe shaft front end portion 12 so that the pipe shaft base end portion 11 and the pipe shaft end portion are connected. The outer periphery of the rear end portion of the portion 12 is covered with a resin cover 13 which is shrunk by a heat-shrinkable resin sleeve (130) to form a catheter tube shaft 10.

According to the electrode catheter 100 of the embodiment, even if the outer diameter of the catheter tube shaft 10 constituting the catheter tube shaft 10 is small, the entire shaft including the distal end portion 12 of the tube shaft has sufficient high rigidity, and all of them can exhibit excellent anti-knot and torque transmission. Sex and extrusion properties.

Further, the catheter tube shaft 10 has a tube shaft base end portion 11 which is formed of a metal sleeve, and the tube shaft distal end portion 12 is formed of a resin sleeve. Therefore, between the tube shaft base end portion 11 and the tube shaft front end portion 12, There is an extreme change in rigidity, so that the kink between the tube shaft base end portion 11 and the tube shaft front end portion 12 can be prevented.

Further, a part of the constituent resin 125 of the pipe shaft tip end portion 12 flows into the slit 115 of the pipe shaft base end portion 11 in the joint portion between the pipe shaft tip end portions 12, so that the pipe shaft front end portion 12 of different kinds of materials can be The tube shaft base end portion 11 is strongly joined.

Further, (W ₁ /W ₀ ) is 1.3 or more, and the connecting portion between the tube shaft base end portion 11 and the tube shaft distal end portion 12 can be an intermediate rigid portion. Thus, the catheter tube shaft 10 can be configured to be inclined toward the distal end direction. When the rigidity is reduced, the knot between the joint portion and the front end portion 12 of the pipe shaft can be surely prevented.

Further, the leads 41, 42, 43, and 44 extending inside the catheter tube shaft 10 can avoid interference with the tensile lead 50, and can prevent lead damage or disconnection caused by interference with the tensile lead 50.

Further, the leads 41, 42, 43, 44 extending inside the catheter tube shaft 10 pass through the inside of the lead protection sleeve 61 composed of a soft sleeve, and extend from the opening of the lead protection sleeve 61 to the operation handle 20. Internally, the opening edge of the base end portion 11 of the tube shaft composed of the metal sleeve is not contacted, so that the leads 41, 42, 43, 44 are not damaged or broken.

In addition, the tensile lead 50 extending to the inside of the catheter tube shaft 10 also protects the inside of the sleeve 62 by a wire formed of a soft sleeve, and the opening of the wire protection sleeve 62 extends to the inside of the operating handle 20 without contact. The open edge of the base end portion 11 of the tube shaft formed of a metal sleeve, so that the tensile lead 50 is not damaged or broken.

<Second embodiment>

The electrode catheter 150 of FIG. 12 to FIG. 15 is for measuring a potential in a portion such as a pulmonary vein of the heart, and includes a catheter tube shaft 15 and an operation handle 25 connected to a proximal end side of the catheter tube shaft 15 and attached thereto. A connector (not shown) that operates the inside of the handle 25, a front end electrode 31 attached to the front end of the catheter tube shaft 15, and seven annular electrodes 32, 33, 34, 35 attached to the outer periphery of the front end portion of the catheter tube shaft 15. 36, 37, 38, the respective front ends are connected to each of the front end electrode 31 and the annular electrode 32-38, extending in the axial direction inside the catheter tube shaft 15, and the individual rear ends are connected to the 8 leads of the connector 41, 42, 43, 44, 45, 46, 47, 48, the front end is fixed to the front end electrode 31, extends in the axial direction inside the catheter tube shaft 15, and the rear end thereof is fixed to the base end portion of the catheter tube shaft 15. a core wire 55; the catheter tube shaft 15 constituting the electrode catheter 150 is configured by a spiral slit 165 formed at a proximal end portion of the tube shaft base end portion 16 formed of a metal sleeve; The inside of the front end region of the front end portion of the base end portion 16 of the tube shaft, and the rear end portion The end portion is inserted into the tube shaft base end portion 16, and the tube shaft distal end portion 17 composed of the multi-cavity resin sleeve (the first multi-lumen sleeve 171 and the second multi-lumen sleeve 172); and the cover tube shaft a resin coating layer 18 on the outer periphery of the base end portion 16 and the rear end portion of the tube shaft front end portion 17; the lead wire 41, the lead wires 42, the lead wires 42, 43, 44, the leads 45, 46, 47, 48 and the core wire 55 It extends to different chambers of the resin sleeve constituting the front end portion 17 of the tube shaft.

Further, the lead electrode 150 is provided with a soft sleeve which is inserted into the inside of the tube shaft base end portion 16 and whose base end portion 651 extends from the opening of the tube shaft base end portion 16 to the inside of the operation handle 25. , A lead protection sleeve 65 having leads 41 to 48 is inserted therein.

Further, in the lead pipe 150, the core wire 55 extending from the opening of the pipe shaft base end portion 16 is folded back toward the front end direction, and the rear end of the core wire 55 is fixed to the outer peripheral side of the pipe shaft base end portion 16 (resin covering The outer surface of layer 18).

The catheter tube shaft 15 constituting the electrode catheter 150 is composed of a tube shaft base end portion 16, a tube shaft distal end portion 17, and a resin coating layer 18.

The length (L ₁₅ ) of the catheter tube shaft 15 is usually set to 600 to 1700 mm, preferably 700 to 1500 mm, and preferably one example is, for example, 1300 mm.

The outer diameter of the catheter tube shaft 15 is preferably set to 1.4 mm or less, preferably one example is, for example, 0.65 mm.

The inner diameter of the catheter tube shaft 15 is preferably set to 1 mm or less, preferably one example is, for example, 0.55 mm.

The tube shaft base end portion 16 of the catheter tube shaft 15 is formed of a metal sleeve having a spiral slit 165 formed at the distal end portion thereof, and has substantially the same configuration as the tube shaft base end portion 11 of the first embodiment. The tube shaft base end portion 11 has the same effect.

The length (L ₁₆ ) of the tube shaft base end portion 16 is usually set to 500 to 1500 mm, preferably 600 to 1200 mm, and preferably one example is, for example, 1030 mm.

The length (L ₁₆₅ ) of the front end portion of the metal bushing in which the spiral slit 165 is formed is usually set to 50 to 200 mm, preferably 100 to 150 mm, preferably one example is, for example, 130 mm.

As shown in Fig. 12, Fig. 14, and Fig. 15, the tube shaft distal end portion 17 of the catheter tube shaft 15 is composed of an insulating resin sleeve having a multi-cavity structure, and the tube shaft distal end portion 12 of the first embodiment. In the same configuration, the same effect as that of the pipe shaft front end portion 12 can be achieved.

The resin sleeve constituting the distal end portion 17 of the tube shaft is formed by melting two multi-lumen sleeves (the first multi-lumen sleeve 171 and the second multi-lumen sleeve 172) having different hardnesses.

As shown in FIG. 15, four cavities (a first cavity 1731, a second cavity 1732, a third cavity 1733, and a fourth cavity 1734) are formed in the first multi-lumen sleeve 171 constituting the rear end portion of the tube shaft distal end portion 17. ). In the figure, 175 is used to form the resin of the first multi-lumen sleeve 171 in the compartments 1731 to 1734.

The second multi-lumen sleeve 172 constituting the front end portion of the tube shaft distal end portion 17 has a multi-cavity structure (cross-sectional shape) similar to that of the first multi-lumen sleeve 171.

The length (L ₁₇ ) of the pipe shaft front end portion 17 is usually set to 100 to 400 mm, preferably 150 to 300 mm, and preferably one example is, for example, 270 mm.

Further, the length (L ₁₇₁ ) of the first multi-lumen sleeve 171 is usually 80 to 300 mm, preferably 100 to 250 mm, and preferably one example is, for example, 220 mm.

Further, the length (L ₁₇₂ ) of the second multi-lumen sleeve 172 is usually set to 15 to 80 mm, preferably 20 to 60 mm, and preferably one example is, for example, 50 mm.

As shown in Fig. 14, the tube shaft front end portion 17 and the tube shaft base end portion 16, and the rear end portion of the former rear end portion (the first multi-chamber sleeve 171) are inserted into the front end portion of the front end portion of the latter (inlaid) And) is linked.

Further, in the catheter tube shaft 15, a part of the resin (the constituent resin 175 of the first multi-lumen sleeve 171) constituting the distal end portion 17 of the tube shaft flows into the slit 165 in the joint portion of the distal end portion 17 of the tube shaft, and flows into the slit. The resin 175 of 165 contacts the resin coating layer 18 and is dissolved in the resin coating layer 18.

As shown in Figs. 14 and 15, the resin coating layer 18 constituting the catheter tube shaft 15 covers the outer periphery of the tube shaft base end portion 16 and the tube shaft distal end portion 17 rear end portion.

The resin coating layer 18 is formed on the outer circumference of the entire length of the tube shaft base end portion 16 and the rear end portion of the tube shaft distal end portion 17 (the first multi-lumen sleeve 171).

The resin coating layer 18 has the same configuration as that of the resin coating layer 13 of the first embodiment, and the same effects as those of the resin coating layer 13 can be achieved.

As shown in Fig. 12, the catheter tube shaft 15 constituting the electrode catheter 150 is linear, and the tube shaft distal end portion 17 in which no external force is applied may have a specific curved shape. The catheter tube shaft having the shape of (memory) is easily deformed by application of an external force (for example, passing the catheter tube shaft through the sheath), and the shape of the curve can be restored after the external force is canceled.

An operation handle 25 is connected to the proximal end side of the catheter tube shaft 15.

The operating handle 25 is a handle that rotates the catheter tube shaft 15 around the shaft. A connector is attached to the inside of the operating handle 25 (not shown in FIG. 12).

The front end electrode 31 is fixed to the front end of the catheter tube shaft 15.

Further, seven annular electrodes 32, 33, 34, 35, 36, 37, 38 are attached to the outer periphery of the front end portion of the catheter tube shaft 15.

Inside the catheter tube shaft 15, eight lead wires, each of which is connected to each of the distal end electrode 31 and the annular electrode 32 to 38, are extended in the axial direction. Further, inside the catheter tube shaft 15, the distal end of the core lead 55 connected to the distal end electrode 31 extends in the axial direction.

As shown in Fig. 15, the three lead wires 42, 43, and 44 connected to the respective annular electrodes 32, 33, and 34 extend to the first cavity of the resin sleeve constituting the distal end portion 17 of the tube shaft (the first multi-chamber sleeve) The first chamber 1731 of the tube 171 and the first chamber of the second multi-lumen sleeve 172 communicating therewith.

The rear ends of the lead wires 42, 43, and 44 are connected to a connector that is mounted inside the operating handle 25.

Further, the leads 45, 46, 47, and 48 connected to the ring-shaped electrodes 35, 36, 37, and 38 extend in the second cavity of the resin sleeve constituting the distal end portion 17 of the tube shaft (the first multi-lumen sleeve 171) The second chamber 1732 and the second chamber of the second multi-lumen sleeve 172 that communicates therewith.

The respective rear ends of the leads 45, 46, 47, 48 are connected to the connectors mounted inside the operating handle 25, similarly to the leads 42, 43, 44.

Moreover, the lead 41 connected to the front end electrode 31 extends over The third cavity of the resin sleeve constituting the distal end portion 17 of the tube shaft (the third chamber 1733 of the first multi-lumen sleeve 171, and the third chamber of the second multi-lumen sleeve 172 communicating therewith). The rear end of the lead wire 41 is connected to the connector attached to the inside of the operating handle 25 in the same manner as the lead wires 42 to 48.

Further, the core lead 55 fixed to the distal end electrode 31 extends in the fourth chamber of the resin sleeve constituting the distal end portion 17 of the tube shaft (the fourth chamber 1734 of the first multi-lumen sleeve 171, and the second most connected thereto) The fourth chamber of the lumen sleeve 172, in addition, extends inside the metal sleeve forming the base end portion 16 of the tube shaft and extends from the opening of the base end portion 16 of the tube shaft to the inside of the operating handle 25.

The front end of the core wire 55 is firmly fixed by solder filled in the inside of the front end electrode 31. Further, the rear end of the core wire 55 is fixed to the outer peripheral side of the base end portion of the pipe shaft base end portion 16 of the catheter tube shaft 15 as will be described later.

In this way, it is possible to surely prevent the front end electrode 31 from coming off or the like.

The lead electrode 150 of this embodiment is not biased by the core wire 55, and the front end of the catheter tube shaft 15 is biased (the front end is biased toward the possible operation of the catheter), but even the lead electrode that does not perform the front end biasing operation, The shape of the tube axis also changes depending on the shape of the blood vessel (sheath), so that means for preventing interference between the core wire 55 and the leads 41 to 48 is necessary.

In this embodiment, the leads 42, 43, and 44 extend in the first cavity, the leads 45, 46, 47, and 48 extend in the second cavity, the lead 41 extends in the third cavity, and the core wire 55 extends in the fourth cavity. Cavity, so can be returned The leads 41 to 48 of the front end portion 17 of the avoidance shaft interfere with the core wire 55.

Further, the core wire 55 and the lead wires 41 to 48 extending toward the different cavities in the tube end portion 17 are separated from each other inside the tube shaft base end portion 16 and are difficult to contact (interfere). As a result, damage or disconnection of the leads 41 to 48 caused by interference with the core wires 55 can be prevented.

As shown in Fig. 16, before the operation of the handle 25, the end side is inserted into the tube shaft base end portion 16 of the catheter tube shaft 15, and the tube shaft base end portion 16 (insertion portion) is screwed to the screw member 251. It is fixed to the operating handle 25.

In this manner, the operation handle 25 can be coupled to the proximal end side of the catheter tube shaft 15 (the tube shaft base end portion 16).

Further, as shown in FIGS. 16 and 17, the lead protection sleeve 65 is inserted into the inside of the tube shaft base end portion 16.

The lead protection sleeve 65 is composed of a soft sleeve, and the base end portion 651 of the lead protection sleeve 65 extends from the opening of the tube shaft base end portion 16 to the inside of the operation handle 25 (outside the tube shaft base end portion 16) .

Lead wires 41 to 48 are inserted into the lead protection sleeve 65, and leads 41 to 48 extend from the opening of the lead protection sleeve 65 to the inside of the operation handle 25 (outside of the lead protection sleeve 65).

The rear ends of the leads 41 to 48 extending from the inside of the operation handle 25 are connected to the connector 75, and an adhesive layer 95 is formed around the connection portion between the rear ends of the leads 41 to 48 and the connector 75 (connector pin). .

Further, the base end portion 651 of the lead protection sleeve 65 extending from the inside of the operation handle 25 is embedded in the adhesive layer 95 and fixed to the lead 41. Connector 75 (operating handle 25) connected to the rear end of ~48.

In this manner, the base end portion 651 of the lead protection sleeve 65 is then fixed to the operation handle 25 for screwing the tube shaft base end portion 16, and the lead protection sleeve 65 can be fixed to the tube shaft base via the operation handle 25. End 16 (position fixed).

The constituent material of the lead protective sleeve 65 may be, for example, the same resin as the lead protective sleeve 61 of the first embodiment, and particularly preferably a polyimide resin.

The length of the lead protection sleeve 65 is usually set to 5 to 500 mm, preferably 10 to 200 mm, and preferably one example is, for example, 30 mm.

Further, the length of the portion inserted into the inside of the tube shaft base end portion 16 is usually 10 to 400 mm, preferably 20 to 200 mm, and preferably one example is, for example, 25 mm.

Further, the outer diameter of the lead protective sleeve 65 is preferably set to 0.36 to 0.80 mm, preferably one example is, for example, 0.40 mm. Further, the inner diameter is preferably set to 0.32 to 0.76 mm, and preferably one example is, for example, 0.36 mm.

In addition, the core wire 55 extending from the opening of the catheter tube shaft 15 (the tube shaft base end portion 16) toward the inside of the operating handle 25 is folded in the front end direction of the opening of the tube shaft base end portion 16 along the base end of the tube shaft. The outer periphery of the portion 16 extends in the distal end direction, and the rear end of the core wire 55 is fixed to the outer peripheral side of the tube shaft base end portion 16 (the outer peripheral surface of the resin coating layer 18 covering the outer periphery of the tube shaft base end portion 16). In this way, the edge of the opening edge of the base end portion 16 of the tube shaft and the core wire 55 are neither in contact with each other nor friction, and do not The damage or disconnection of the core wire 55 can also be prevented when the soft sleeve is protected.

A resin coating layer 19 is formed on one of the outer peripheral surfaces of the resin coating layer 18 covering the base end portion 16 of the tube shaft (the outer peripheral surface at which the core wire 55 is folded at least in the distal end direction). The resin cover layer 19 can be formed by shrinkage of a heat shrinkable resin sleeve.

According to the electrode catheter 150 of the embodiment, the outer diameter of the catheter tube shaft 15 constituting the catheter tube 15 is small, and the entire shaft including the distal end portion 17 of the tube shaft has sufficient high rigidity, and the entire nucleus resistance and torque transmission property can be exhibited. And extrusion characteristics.

Further, there is no extreme change in rigidity between the pipe shaft base end portion 16 and the pipe shaft front end portion 17, and thus, the kink between the pipe shaft base end portion 16 and the pipe shaft front end portion 17 can be prevented.

Further, when a part of the constituent resin 175 of the pipe shaft tip end portion 17 flows into the slit 165 of the pipe shaft base end portion 16 in the joint portion of the pipe shaft tip end portion 17, the pipe shaft front end portion 17 of different kinds of materials can be The tube shaft base end portion 16 is strongly joined.

In addition, the leads 41 to 48 extending inside the catheter tube shaft 15 are formed inside the lead protection sleeve 65 formed by the flexible sleeve, and the opening of the lead protection sleeve 65 extends toward the inside of the operation handle 25, and thus The opening edge of the base end portion 11 of the tube shaft formed of the metal sleeve is not in contact, and the leads 41 to 48 are not damaged or broken.

10‧‧‧ catheter tube shaft

11‧‧‧The base end of the tube shaft

13‧‧‧ resin cover

20‧‧‧Operation handle

22‧‧‧ knob

23‧‧‧ rotating plate

41~44‧‧‧Leader

50‧‧‧Stretched wire

61‧‧‧Lead protection sleeve

62‧‧‧Wire protection sleeve

80‧‧‧ components

81,82‧‧‧ base

90‧‧‧ front end

90‧‧‧Adhesive

611‧‧‧ base part

621‧‧‧ base part

Claims (10)

An electrode catheter comprising: a catheter tube shaft connected by a base end portion of a tube shaft formed of a metal sleeve, and a front end portion of a tube shaft formed of a resin sleeve; and an operation handle connected to the above a base end side of the catheter tube shaft; the connector is disposed on the operation handle; the front end electrode is attached to the front end of the catheter tube shaft; and the lead wire is connected to the front end electrode at the inner edge of the catheter tube shaft Extending in the axial direction to reach the inside of the operating handle, the rear end of which is connected to the connector; a wire whose front end is fixed to the front end electrode or the front end portion of the catheter tube shaft, along the inside of the catheter tube axis Extending in the axial direction, the rear end thereof is fixed to the operation handle or the base end portion of the catheter tube shaft; and the lead protection sleeve is installed by inserting the inside of the base end portion of the tube shaft, and the base end portion thereof is attached The soft sleeve extends from the opening of the base end of the tube shaft to the inside of the operating handle, and the lead wire is inserted into the inside. The electrode catheter of claim 1, comprising: at least one annular electrode mounted on a front end portion of the catheter tube shaft; and a plurality of lead wires each having a front end connected to each of the front end electrodes and the above a ring-shaped electrode extending along the axis inside the catheter tube axis Extending into the inside of the operating handle, the individual rear ends are connected to the connector; and the lead protection sleeve is installed by inserting the inside of the base end of the tube shaft, the base end portion of which is The opening of the base end of the tube shaft extends to a soft sleeve inside the operating handle, and the plurality of leads are inserted through the inside. The lead electrode according to claim 1 or 2, wherein the front end of the catheter tube shaft is biased by performing a stretching operation on the rear end of the wire, and the wire protection sleeve is provided by inserting the tube shaft base The inside of the end portion is mounted, and the base end portion is formed by a soft sleeve extending from the opening of the base end portion of the tube shaft to the inside of the operating handle, and the lead wire is inserted through the inside. The electrode catheter of claim 3, wherein each of the lead protection sleeve and the wire protection sleeve is fixed to the base end of the tube shaft via a connection member connecting the base end portion of the tube shaft and the operation handle. unit. The lead electrode according to claim 1 or 2, wherein the rear end of the lead wire extending from the opening of the base end portion of the tube shaft is fixed to the outer peripheral side of the base end portion of the tube shaft, and the lead protective sleeve is The base end portion of the tube is followed by the operation handle for fixing the base end portion of the tube shaft such that the lead protection sleeve is fixed to the tube shaft base end portion. For example, the electrode of the first or second patent application, wherein The above lead protection sleeve is composed of a polyimide sleeve. The electrode catheter of claim 3, wherein the lead protection sleeve and the wire protection sleeve are composed of a polyimide sleeve. The lead electrode according to any one of claims 1 to 7, wherein at least a front end portion of the metal sleeve constituting the base end portion of the tube shaft is formed with a spiral slit. The electrode catheter according to any one of claims 1 to 8, wherein the above-mentioned resin sleeve has a multi-lumen configuration. The electrode catheter according to any one of claims 1 to 9, wherein the outer diameter of the catheter tube shaft is 1.4 mm or less.