JP2017063985A - Balloon catheter and chemical ablation device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter that prevents obstruction of movement (including insertion and removal operations) of a guide wire in a guide wire lumen even when ethanol is fed to the guide wire lumen with the guide wire inserted therein, and also having excellent followability of a blood vessel shape.SOLUTION: A balloon catheter of observer wire type includes an inner tube 41, an outer tube 43, and a balloon 45. The inner tube 41 includes: a proximal end 46 that has an inner layer 48 formed of a resin having good ethanol resistance and that has relatively high rigidity; and a distal tip part 47 formed of a resin and having relatively low rigidity. The inner diameter (d) of the distal tip part 47 is larger than the inner diameter (d) of the proximal end 46.SELECTED DRAWING: Figure 4A

Description

  The present invention relates to a balloon catheter and a chemical ablation apparatus that can be suitably used for, for example, a method of injecting ethanol into a Marshall vein.

As a catheter treatment for atrial fibrillation, a chemical ablation method (ethanol injection method in the Marshall vein) in which arrhythmia origin tissue is necrotized by injecting and administering ethanol into the Marshall vein has been attracting attention (see Non-Patent Document 1 below).
Here, the Marshall vein (VOM) is a vein that branches from the coronary sinus and travels on the epicardial side from the left atrial posterior wall toward the side wall.

Heart Rhythem. 2009 November; 6 (11): 1552-1558 (Ethanol Infusion in Vein of Marshall: Adjusted Effects of Abrasion of Attribution)

  As a method of injecting and administering ethanol into the Marshall vein, a parent guiding catheter, a child guiding catheter that can be inserted through the lumen of the parent guiding catheter, and a potential (pacing and / or mapping) for measuring the potential in the Marshall vein A chemical ablation system that includes an electrode catheter and a balloon catheter that injects ethanol from the distal tip is used, and a method that is carried out according to the following procedures (1) to (9) is conceivable.

  Here, the electrode catheter and the balloon catheter constituting this system are inserted into and extracted from the Marshall vein along the guide wire. Therefore, the electrode catheter is a cylindrical body in which a guide wire lumen is formed. The balloon catheter is an over-the-wire type double lumen structure having a guide wire lumen and an expansion lumen.

(1) Insertion of parent guiding catheter:
First, with the approach from the superior vena cava, the tip of the parent guiding catheter is engaged with the entrance of the coronary sinus.

(2) Insertion of child guiding catheter:
Next, the child guiding catheter is inserted into the lumen of the parent guiding catheter, and the distal end of the child guiding catheter extended from the distal opening of the parent guiding catheter is positioned in the vicinity of the entrance portion of the Marshall vein.

(3) Inserting the guide wire:
Next, a guide wire is inserted into the lumen of the child guiding catheter, and the distal end portion of the guide wire extending from the distal opening of the child guiding catheter is inserted into the Marshall vein. This operation is usually performed while viewing an X-ray image under fluoroscopy.

(4) Insertion of electrode catheter (electric potential measurement):
Next, the cylindrical electrode catheter is inserted into the lumen of the child guiding catheter along the guide wire, and the distal end portion where the electrode is attached is extended from the distal opening of the child guiding catheter to the Marshall vein. Insert and perform potential measurement (pacing mapping) before treatment.

(5) Removal of electrode catheter and insertion of balloon catheter:
Next, the electrode catheter was removed along the guide wire, and the over-the-wire type balloon catheter was inserted into the lumen of the child guiding catheter along the guide wire and extended from the distal end opening of the child guiding catheter. Insert the tip into the Marshall vein.

(6) Guidewire removal and ablation treatment:
Next, after the guide wire inserted into the guide wire lumen of the balloon catheter is removed and the balloon is expanded, ethanol is injected into the guide wire lumen from the hemostasis valve connected to the rear end of the balloon catheter. The injected ethanol is injected into the Marshall vein from the opening of the tip via the guide wire lumen of the balloon catheter, thereby performing chemical ablation. In addition, chemical ablation (injection of ethanol) is usually started from the back side where the capillaries are located, and multiple times (3 to 4 times) while moving the balloon catheter stepwise in the direction where the inlet portion is located. ) Is performed separately.

(7) Reinsertion of guide wire:
Next, the guide wire removed during the ablation treatment is reinserted into the Marshall vein along the guide wire lumen of the balloon catheter.

(8) Removal of balloon catheter:
Next, the balloon catheter is removed along the reinserted guide wire.

(9) Reinsertion of electrode catheter (potential measurement):
Next, the electrode catheter used in (4) above is inserted into the lumen of the parent guiding catheter along the guide wire, and the distal end where the electrode is attached is reinserted into the Marshall vein to measure the potential after treatment. Perform (pacing mapping).

  If it is determined that the ablation is insufficient as a result of the potential measurement, the operations (5) to (9) are repeated.

  However, the procedure (ablation treatment including potential measurement before and after treatment) performed using the chemical ablation system as described above is extremely complicated.

  In response to such a problem, the present inventor, as a chemical ablation apparatus that can easily perform chemical ablation treatment including potential measurement before and after treatment, a guide wire with an electrode capable of measuring intracardiac potential; An inner tube having a guide wire lumen through which the attached guide wire is inserted; an outer tube disposed outside the inner tube to form an expansion lumen; and a rear end attached to a distal end of the outer tube. An over-the-wire type balloon catheter having a balloon disposed on the outside and a distal end tip extending from the distal end of the balloon continuously to the inner tube; and connected to a rear end side of the balloon catheter; The guide wire lumen of the balloon catheter A Y-connector having a guide wire port communicating therewith and an expansion port communicating with an expansion lumen of the balloon catheter; a drug solution for ablation connected to the guide wire port of the Y-connector; A chemical ablation apparatus that injects ethanol supplied to the guide wire lumen of the balloon catheter from the opening of the tip. (See Japanese Patent Application No. 2014-206899).

  A guide wire with an electrode constituting the chemical ablation apparatus includes a core wire, a resin shaft including at least a tip portion excluding the most distal end portion of the core wire, and a rear end of the resin shaft with or without a metal shaft. A connector connected to the side, a plurality of ring-shaped electrodes mounted on the outer periphery of the resin shaft, and each of the ring-shaped electrodes, and inserted into the resin shaft and connected to the connector And has both the function of a guide wire and the function of an electrode catheter in a conventional apparatus.

  In such a chemical ablation apparatus, the guide from the side injection tube provided in the hemostasis valve connected to the guide wire port of the Y-shaped connector in a state where the guide wire with electrode is inserted through the guide wire lumen of the balloon catheter. By supplying ethanol to the wire lumen, ethanol can be injected to the target site from the opening of the tip (a gap between the opening and the guide wire with electrode extending from the opening). Treatment can be performed in an indwelling state, and potential measurement after treatment can be performed immediately. If it is determined from the measured potential that the treatment is insufficient, the treatment can be resumed immediately.

  Therefore, in the conventional apparatus, the electrode catheter inserted for measuring the potential before treatment is removed during the treatment (the above procedure (5)), or the guide wire is removed during the treatment (the above-mentioned procedure). Procedure (6)), for measuring the potential after treatment, reinserting the guide wire, removing the balloon catheter, reinserting the electrode catheter (the above procedures (7) to (9)) There is no need to perform complicated operations.

  However, during the treatment with such a chemical ablation apparatus, ethanol is supplied to the guide wire lumen of the balloon catheter constituting the apparatus, and ethanol contacts the inner periphery of the inner tube. As a result, the resin constituting the inner tube is eroded by ethanol and gradually swells, and accordingly, the guide wire lumen is reduced in diameter, and the guide wire with the electrode is fixed by the swollen resin, whereby the guide wire It becomes impossible to move the guide wire with electrode in the lumen, or the ethanol flow path (gap between the inner periphery of the inner tube and the outer periphery of the guide wire) in the guide wire lumen is blocked, and the tip of the balloon catheter In some cases, it may become impossible to inject ethanol from the opening (in this case, if the supply is continued, ethanol will flow backward).

In order to avoid such problems, it is conceivable that the inner tube is formed of a resin having good ethanol resistance, or the inner layer of the inner tube having a two-layer structure is formed of a resin having good ethanol resistance. .
However, when an inner tube is formed using a resin having good ethanol resistance (for example, polyimide resin), the inner tube has high rigidity and is difficult to bend, and a balloon catheter provided with the inner tube is inferior in blood vessel shape followability. In other words, since it cannot be deformed following a complicated blood vessel shape, it is inferior in its insertion into such a blood vessel.

The present invention has been made based on the above situation.
An object of the present invention is to prevent movement of a guide wire (including insertion / extraction operation) in the guide wire lumen even if ethanol is supplied to the guide wire lumen in a state where the guide wire (guide wire with electrode) is inserted. It is another object of the present invention to provide a balloon catheter that can follow a complicated blood vessel shape.
Another object of the present invention is to provide a chemical ablation apparatus that can easily perform a chemical ablation treatment including potential measurement before and after the treatment, in particular, a procedure relating to an ethanol injection method into a Marshall vein.

(1) The balloon catheter of the present invention is attached to an inner tube having a guide wire lumen through which a guide wire is inserted, an outer tube disposed outside the inner tube to form an expansion lumen, and a distal end of the outer tube. An over-the-wire balloon catheter having a balloon disposed outside the inner tube,
The inner tube has a relatively rigid base end portion having at least an inner layer formed of a resin having good ethanol resistance, and a relatively rigid distal end tip portion formed of a resin. Become
An inner diameter of the distal tip portion is larger than an inner diameter of the base end portion.

  In the balloon catheter of the present invention, the ratio of the inner diameter of the distal tip portion to the inner diameter of the proximal end portion is preferably 1.02 or more.

  According to the balloon catheter having such a configuration, at least the inner layer is formed of a resin having good ethanol resistance at the base end portion of the inner tube, so even if ethanol contacts the inner periphery of the base end portion. The constituent resin of the base end can be prevented from swelling.

On the other hand, the tip part of the inner tube is not made of a resin having good ethanol resistance, but the inner diameter of the tip part is larger than the inner diameter of the base part, so that the constituent resin of the tip part is swollen. Even if the guide wire lumen in the tip portion is reduced, the inner diameter after the reduction is secured to some extent, so that the guide wire can be prevented from being fixed by the swollen resin. As a result, the guide wire Can be prevented from being hindered (including insertion and removal operations). In addition, even after the diameter reduction, it is possible to secure an ethanol flow path (a gap between the inner periphery of the tip part and the outer periphery of the guide wire) in the guide wire lumen, so that ethanol can be supplied from the opening of the tip part. Can be injected.
Moreover, even if the proximal end portion of the inner tube is difficult to bend, the tip portion is easy to be bent. Therefore, the balloon provided with such an inner tube has excellent followability to the blood vessel shape.

  In the balloon catheter of the present invention, the difference between the inner diameter of the proximal end portion and the outer diameter of the guide wire inserted through the guide wire lumen is 0.05 to 0.60 mm, and the inner diameter of the distal tip portion is The difference from the inner diameter of the base end is preferably 0.02 mm or more.

In the balloon catheter of the present invention, it is preferable that a joint portion between the proximal end portion and the distal tip portion is located inside the balloon.
According to the balloon catheter having such a configuration, it is possible to combine the insertion property of the guide wire in the guide wire lumen to which ethanol is supplied and the followability to the blood vessel shape in a well-balanced manner.

In the balloon catheter of the present invention, it is preferable that the outer diameter of the distal tip portion is equal to the outer diameter of the proximal end portion (the outer tube has no step at the boundary between the distal tip portion and the proximal end portion).
According to the balloon catheter having such a configuration, since the outer diameter of the distal tip portion can be reduced, insertion into a sheath or blood vessel can be improved.

In the balloon catheter of the present invention, the proximal end portion is composed of a two-layer tube composed of an inner layer formed of a resin having good ethanol resistance and an outer layer formed of a resin,
It is preferable that the tip part is constituted by a single-layer tube made of the same resin as that of the outer layer of the base end part.

  In this case, it is preferable that the constituent resin of the outer layer of the base end portion and the tip end portion is a polyether block amide copolymer, and the constituent resin of the inner layer of the base end portion is polyimide.

  In the balloon catheter of the present invention, it is preferable that the guide wire is a guide wire with an electrode capable of measuring an intracardiac potential.

The chemical ablation apparatus of the present invention comprises a guide wire with an electrode,
A balloon catheter of the present invention;
A Y-shaped connector having a guide wire port and an expansion port;
And a hemostasis valve connected to a guide wire port of the Y-shaped connector and having a side injection tube for supplying ethanol to the guide wire lumen.

  According to the balloon catheter of the present invention, even if ethanol is supplied to the guide wire lumen in a state where the guide wire (guide wire with electrode) is inserted, the guide wire moves (including insertion / extraction operations) in the guide wire lumen. In addition, the balloon catheter of the present invention can be easily inserted into such a blood vessel following a complicated blood vessel shape.

  According to the chemical ablation apparatus of the present invention, it is possible to easily perform a chemical ablation treatment including potential measurement before and after the treatment, in particular, a technique relating to a method of injecting ethanol into the Marshall vein.

It is a side view which shows the balloon catheter which concerns on 1st Embodiment of this invention. FIG. 2 is a partially enlarged view (part II detail view) of FIG. 1. FIG. 3 is a sectional view taken along line IIIA-IIIA in FIG. 2. FIG. 3 is a sectional view taken along the line IIIB-IIIB in FIG. 2. FIG. 3 is a partially enlarged sectional view of FIG. 2. It is a partial expanded sectional view of Drawing 4A. It is a partial expanded sectional view of the balloon catheter which concerns on 2nd Embodiment of this invention. It is a partial expanded sectional view of Drawing 5A. It is a partial expanded sectional view of the balloon catheter which concerns on 3rd Embodiment of this invention. It is a partial expanded sectional view of the balloon catheter which concerns on 4th Embodiment of this invention. It is a partial expanded sectional view of the balloon catheter which concerns on 5th Embodiment of this invention. It is a partial expanded sectional view of the balloon catheter which concerns on 6th Embodiment of this invention. It is a side view which shows an example of the chemical ablation apparatus provided with the balloon catheter of this invention. It is XIA-XIA sectional drawing of FIG. It is XIB-XIB sectional drawing of FIG. It is a side view which shows the guide wire with an electrode which comprises the chemical ablation apparatus shown in FIG. It is the elements on larger scale of FIG. 12 (XIII part detail drawing). It is XIV-XIV sectional drawing of FIG. It is XVA-XVA sectional drawing of FIG. It is XVB-XVB sectional drawing of FIG. It is XVC-XVC sectional drawing of FIG. It is XVD-XVD sectional drawing of FIG. It is XVE-XVE sectional drawing of FIG. It is explanatory drawing which shows the use condition of the chemical ablation apparatus shown in FIG.

<First Embodiment>
The balloon catheter 40 of this embodiment shown in FIGS. 1-4 (FIG. 4A and 4B) is a balloon catheter used for the ethanol injection method to a Marshall vein.
The balloon catheter 40 is attached to an inner tube 41 having a guide wire lumen 42 through which a guide wire is inserted, an outer tube 43 disposed outside the inner tube 41 to form an expansion lumen 44, and a distal end of the outer tube 43. An over-the-wire type balloon catheter having a balloon 45 disposed outside the inner tube 41, the inner tube 41 having a relatively rigid base end portion 46 and a relatively low stiffness. The tip end portion 47 is joined, and the base end portion 46 of the inner tube 41 is formed by a two-layer tube including an inner layer 48 formed of a resin having good ethanol resistance and an outer layer 49 formed of a resin. The distal end tip portion 47 of the inner tube 41 is configured with a proximal end portion 46. Is constituted by a single layer tube having the structure resin the same resin of the outer layer 49, the inner diameter of the distal tip portion 47 (d ₁₎ is larger than the inner diameter of the proximal end 46 (d _2), the ratio (d ₁ ) / (D ₂ ) is a balloon catheter having a value of 1.02 or more.

  The balloon catheter 40 of this embodiment is an over-the-wire type balloon catheter having an inner tube 41, an outer tube 43, and a balloon 45.

The inner tube 41 constituting the balloon catheter 40 has a guide wire lumen 42 having an inner diameter through which a guide wire (not shown) can be inserted.
The guide wire lumen 42 serves as an insertion path for the guide wire and a flow path for ethanol, which is a chemical solution for ablation.
Contrast markers 417 are attached to the outer periphery (two locations) of the inner tube 41 inside the balloon 45.

The inner tube 41 is formed by joining a base end portion 46 having a relatively high rigidity and a tip portion 47 having a relatively low rigidity.
Specifically, the resin tube constituting the base end portion 46 and the resin tube constituting the distal end tip portion 47 are joined by heat-sealing.

  The base end portion 46 of the inner tube 41 is configured by a two-layer resin tube including an inner layer 48 and an outer layer 49.

The inner layer 48 constituting the base end portion 46 of the inner tube 41 is formed of a resin having good ethanol resistance.
Here, the “resin having good ethanol resistance” refers to a resin that is insoluble in ethanol and hardly causes swelling or alteration when brought into contact with ethanol.
Examples of such a resin include polyimide, a fluororesin such as PTFE and PFA, a rubber-based resin, and polyethylene. Of these, polyimide is preferable.

  However, a resin having good ethanol resistance that can be used as a constituent material of the inner tube 41 has high rigidity. Thereby, the rigidity of the base end portion 46 is inevitably increased, and the base end portion 46 is hardly bent.

  As the resin forming the outer layer 49 constituting the base end portion 46 of the inner tube 41, a conventionally known resin constituting the inner tube can be used. For example, polyolefin, polyamide, polyether polyamide, polyurethane, nylon, Synthetic resins such as PEBAX (registered trademark) (polyether block amide copolymer) can be mentioned, and among these, a flexible resin is preferable from the viewpoint of reducing the rigidity of the base end portion 46, specifically Is preferably PEBAX.

  The tip part 47 of the inner tube 41 is composed of a single layer resin tube. Since the distal end tip portion 47 has lower rigidity than the proximal end portion 46, flexibility can be imparted to the distal end portion of the inner tube 41. Thereby, the balloon catheter 40 provided with the inner tube 41 can be made excellent in followability to the blood vessel shape.

  The resin that forms the tip portion 47 (single-layer resin tube) of the inner tube 41 is not particularly limited as long as it is a resin that can form a tube having a lower rigidity than the base end portion 46. For example, what was illustrated as resin which forms the outer layer 49 of the base end part 46 can be mentioned. Among these, it is preferable to use the same resin as the constituent resin of the outer layer 49 of the base end portion 46, and specifically, PEBAX is preferable.

As shown in FIG. 4 (FIGS. 4A and 4B), the inner diameter (d ₁ ) of the distal tip portion 47 is larger than the inner diameter (d ₂ ) of the proximal end portion 46.

Here, the inner diameter (d ₂ ) of the base end 46 is 0.05 to less than the outer diameter of the inserted guide wire from the viewpoint of securing the ethanol flow path even when the guide wire is inserted. It is preferably about 0.60 mm larger.
Specifically, it is preferably 0.68 mm or more, more preferably 0.70 to 0.90 mm, and 0.78 mm if a suitable example is shown.

The outer diameter (D ₂ ) of the base end portion 46 is preferably 0.80 to 1.00 mm, and 0.90 mm if a suitable example is shown.

  The length of the base end portion 46 is preferably 800 to 1500 mm, and 1100 mm if a suitable example is shown.

The inner diameter (d ₁ ) of the distal tip portion 47 is 0.07 to 0. 0 from the outer diameter of the inserted guide wire from the viewpoint of securing the ethanol flow path even after the resin swells due to contact with ethanol. It is preferably about 62 mm larger.
Specifically, it is preferably 0.70 mm or more, more preferably 0.72 to 0.92 mm, and 0.81 mm if a suitable example is shown.

The outer diameter (D ₁ ) of the tip part 47 is preferably 0.85 to 1.05 mm, and 0.93 mm if a suitable example is shown.

  The length of the tip part 47 is preferably 1 to 12 mm, and 6 mm if a suitable example is shown.

The ratio (d ₁ ) / (d ₂ ) of the inner diameter of the distal end tip portion 47 to the inner diameter of the base end portion 46 is preferably 1.02 or more, more preferably 1.02 to 1.10, a suitable example. In other words, it is 1.04 (≈0.81 / 0.78).
When this ratio (d ₁ ) / (d ₂ ) is less than 1.02, it may be difficult to move the guide wire in the guide wire lumen 42.

The difference [(d ₁ ) − (d ₂ )] between the inner diameter of the tip part 47 and the inner diameter of the base part 46 is preferably 0.02 mm or more, more preferably 0.02 to 0.10 mm. A suitable example is 0.03 mm (0.81 mm-0.78 mm).

The outer tube 43 constituting the balloon catheter 40 forms an expansion lumen 44 that serves as a fluid flow path for expanding the balloon 45.
Here, the fluid supplied to the expansion lumen 44 can be exemplified by physiological saline.

The outer diameter of the outer tube 43 is preferably 1.00 to 1.70 mm, and 1.21 mm if a suitable example is shown.
The inner diameter of the outer tube 43 is preferably 0.80 to 1.55 mm, and is 1.00 mm if a suitable example is shown.
The length of the outer tube 43 is preferably 700 to 1300 mm, and 1000 mm if a suitable example is shown.

  Examples of the constituent material of the outer tube 43 include synthetic resins such as polyolefin, polyamide, polyether polyamide, polyurethane, nylon, PEBAX (registered trademark) (polyether block amide), and among these, PEBAX is preferable.

The balloon 45 constituting the balloon catheter 40 is mounted on the distal end of the outer tube 43 and is disposed outside the inner tube 41 extending from the distal end of the outer tube 43.
The diameter when the balloon 45 is expanded is usually 1.0 to 3.0 mm, and preferably 1.5 to 2.5 mm.
The length of the balloon 45 is usually 5 to 30 mm, preferably 10 to 20 mm.
As a constituent material of the balloon 45, the same material as that of a conventionally known balloon catheter can be used, and PEBAX can be cited as a suitable material.

  As shown in FIG. 1, a Y-shaped connector 50 is attached to the rear end side of the balloon catheter 40. The Y-shaped connector 50 has a guide wire port 51 that communicates with the guide wire lumen 42 of the balloon catheter 40 and an expansion port 53 that communicates with the expansion lumen 44 of the balloon catheter 40. In the figure, reference numeral 55 denotes a strain relief.

A hemostasis valve 60 is attached to the guide wire port 51 of the Y-shaped connector 50.
The guide wire is inserted into the guide wire lumen 42 of the balloon catheter 40 from the guide wire port 51 of the Y-shaped connector 50 through the hemostasis valve 60.
The hemostasis valve 60 includes a side injection tube 65 from which ethanol, which is a chemical solution for ablation, is supplied.
Ethanol supplied from the side injection tube 65 to the hemostasis valve 60 is supplied from the guide wire port 51 of the Y-shaped connector 50 to the guide wire lumen 42 of the balloon catheter 40, and the distal end opening of the inner tube 41 (tip tip portion 47). Is injected from.

  According to the balloon catheter 40 of the present embodiment, since the inner layer 48 of the base end portion 46 of the inner tube 41 is formed of a resin having good ethanol resistance, ethanol contacts the inner periphery of the base end portion 46. However, the constituent resin of the base end portion 46 does not swell.

On the other hand, the tip portion 47 of the inner tube 41 is not made of a resin having good ethanol resistance, but the inner diameter (d ₁ ) of the tip portion 47 is larger than the inner diameter (d ₂ ) of the base end portion 46. (For example, the ratio (d ₁ ) / (d ₂ ) is 1.04). Therefore, even if the constituent resin of the tip part 47 swells and the guide wire lumen 42 in the tip part 47 is reduced in diameter, Since the inner diameter after the diameter is secured to some extent (maintained to the same degree as the inner diameter of the base end portion 46), the guide wire can be prevented from being fixed by the swollen resin. As a result, the guide wire It is possible to prevent the movement operation including the insertion / removal operation of the hindering.

  In addition, even after the diameter reduction, the gap between the inner periphery of the inner tube 41 and the outer periphery of the guide wire is not closed, and the ethanol flow path in the guide wire lumen 42 can be secured. Ethanol can be injected from the tip opening of the tip portion 47).

  Moreover, even if the proximal end portion 46 of the inner tube 41 is difficult to bend, the distal tip portion 47 is easily bent. Therefore, the balloon catheter 40 of this embodiment provided with such an inner tube 41 follows the blood vessel shape. Excellent in properties.

  Further, since the joint portion between the proximal end portion 46 and the distal end tip portion 47 of the inner tube 41 is located inside the balloon 45, the balloon catheter of the present embodiment is provided in the guide wire lumen 42 supplied with ethanol. It has a good balance between the insertion of the guide wire and the followability of the balloon catheter 40 to the blood vessel shape.

Second Embodiment
The balloon catheter 402 of the present embodiment whose main part is shown in FIG. 5 (FIGS. 5A and 5B) is different from the balloon catheter 40 of the first embodiment only in the form of the inner tube 412 constituting the balloon catheter 402.
That is, in the inner tube 412, the inner diameter (d ₁ ) of the distal end tip portion 472 is larger than the inner diameter (d ₂ ) of the proximal end portion 462, but the outer diameter (D) of the distal end tip portion 472 and the proximal end The outer diameter (D) of the portion 462 is equal, and there is no step on the outer periphery of the inner tube 412 at the joint portion between the distal tip portion 472 and the proximal end portion 462.

Here, the inner diameter (d ₂ ) of the base end portion 462 is preferably larger by about 0.05 to 0.60 mm than the outer diameter of the guide wire to be inserted.
Specifically, it is preferably 0.68 mm or more, more preferably 0.70 to 0.90 mm, and 0.78 mm if a suitable example is shown.

The inner diameter (d ₁ ) of the tip portion 472 is preferably about 0.07 to 0.62 mm larger than the outer diameter of the inserted guide wire.
Specifically, it is preferably 0.70 mm or more, more preferably 0.72 to 0.92 mm, and 0.81 mm if a suitable example is shown.

The ratio (d ₁ ) / (d ₂ ) of the tip tip portion 472 inner diameter to the inner diameter of the base end portion 462 is preferably 1.02 or more, more preferably 1.02 to 1.10, and a suitable example. In other words, it is 1.04 (≈0.81 / 0.78).

  The outer diameter (D) of the inner tube 412 is preferably 0.80 to 1.00 mm, and 0.90 mm if a suitable example is shown.

  According to the balloon catheter 402 of the present embodiment, the same effect as that of the balloon catheter 40 of the first embodiment can be obtained, and there is no step on the outer periphery of the inner tube 412, and the outer diameter of the tip portion can be reduced. In addition, the insertion property into the sheath or blood vessel can be improved.

<Third Embodiment>
The balloon catheter 403 of the present embodiment whose main part is shown in FIG. 6 is different from the balloon catheter 40 of the first embodiment only in the form of the inner tube 413 constituting the balloon catheter 403.
That is, in the inner tube 413, the joined portion between the distal tip portion 473 and the proximal end portion 463 is located on the distal end side (near the distal end of the balloon 45) than the joined portion in the first embodiment.
According to such a balloon catheter 403, the guide wire insertion property in the guide wire lumen 42 supplied with ethanol is particularly excellent.
In addition, when the joining part of the tip part and the base part is further on the tip side than the position shown in FIG. 6 (for example, on the tip side of the balloon 45), the length of the tip part is long. Therefore, the followability to the blood vessel shape may be deteriorated.

<Fourth embodiment>
The balloon catheter 404 of the present embodiment whose main part is shown in FIG. 7 is different from the balloon catheter 403 of the third embodiment only in the form of the inner tube 414 constituting the balloon catheter 404.
That is, in the inner tube 414, the outer diameter (D) of the distal end tip portion 474 and the outer diameter (D) of the proximal end portion 464 are equal, and the inner tube 414 is joined at the joint portion between the distal end tip portion 474 and the proximal end portion 464. There is no step on the outer periphery of the.

<Fifth Embodiment>
The balloon catheter 405 of the present embodiment whose main part is shown in FIG. 8 is different from the balloon catheter 40 of the first embodiment only in the form of the inner tube 415 constituting the balloon catheter 405.
That is, in the inner tube 415, the joint portion between the distal tip portion 475 and the base end portion 465 is located on the base end side (near the base end of the balloon 45) with respect to the joint portion in the first embodiment.
Since such a balloon catheter 405 has a sufficient length of the tip portion 475 in the inner tube 415, the tip portion 475 is excellent in flexibility, and the followability to the blood vessel shape is particularly excellent. .
In addition, when the joining part of the tip part and the base end part is further on the base end side than the position shown in FIG. 7 (for example, on the base end side from the base end of the balloon 45), The guide wire insertion property of the supplied guide wire lumen 42 may deteriorate.

<Sixth Embodiment>
The balloon catheter 406 of the present embodiment whose main part is shown in FIG. 9 is different from the balloon catheter 405 of the fifth embodiment only in the form of the inner tube 416 constituting the balloon catheter 406.
That is, in the inner tube 416, the outer diameter of the distal end tip portion 476 and the outer diameter of the proximal end portion 466 are equal, and there is no step on the outer periphery of the inner tube 416 at the joint portion between the distal end tip portion 476 and the proximal end portion 466. .

<Chemical ablation equipment>
FIG. 10 is a side view showing an example of a chemical ablation apparatus provided with the balloon catheter of the present invention.
This chemical ablation apparatus shown in FIGS. 10 to 15 (FIGS. 15A to 15D) includes a core wire 31, a coil spring 33 attached along the axial direction at the most distal end portion of the core wire 31, and the most distal end portion of the core wire 31. A resin shaft 35 including a tip portion excluding the metal shaft 37, a metal shaft 37 connected to the rear end side of the resin shaft 35, a connector 39 connected to the rear end side of the metal shaft 37, and the most distal portion of the core wire 31 Are connected to each of the electrodes 361, 362 mounted on the ring, the ring-shaped electrodes 363, 364, 365, 366 mounted on the outer periphery of the resin shaft 35, and the electrodes 361-366, and the resin shaft 35 and the metal shaft 37. A lead wire 381 to 386 inserted into the connector and connected to the connector 39 to measure an intracardiac potential And Kiwametsuki guidewire 30;
The balloon catheter 40 of the first embodiment of the present invention;
A Y-connector 50 connected to the rear end side of the balloon catheter 40 and having a guide wire port 51 communicating with the guide wire lumen 42 of the balloon catheter 40 and an expansion port 53 communicating with the expansion lumen 44 of the balloon catheter 40;
A hemostasis valve 60 connected to the guide wire port 51 of the Y-shaped connector 50 and having a side injection tube 65 for supplying ethanol, which is a chemical solution for ablation, to the guide wire lumen 42 of the balloon catheter 40;
The ethanol supplied to the guide wire lumen 42 of the balloon catheter 40 passes through the guide wire lumen 42 (the guide wire lumen with the electrode-equipped guide wire 30 inserted), and the distal end opening of the inner tube 41 (the distal end tip portion 47). It is a device which injects from

The electrode-equipped guide wire 30 constituting the chemical ablation apparatus is a small-diameter electrode catheter that can be used as a guide wire.
The electrode-equipped guide wire 30 includes a core wire 31, a coil spring 33, a resin shaft 35, a metal shaft (hypotube) 37, a connector 39, electrodes 361 to 366, and conductive wires 381 to 386. .
In addition, in FIGS. 13-14, FIG. 15B, and FIG. 15D, 341 and 342 are each the ring-shaped insulation members comprised from an adhesive agent.
Reference numeral 345 denotes a strain relief made of a resin material.

The core wire 31 constituting the electrode-equipped guide wire 30 usually has a distal end side small diameter portion 311 and a proximal end large diameter portion 312 having a larger outer diameter than the distal end side small diameter portion.
As shown in FIG. 14, in the present embodiment, the tip end portion of the core wire 31 is configured by the distal end side small diameter portion 311.
In addition, the taper part from which an outer diameter changes along an axial direction between the front end side small diameter part 311 and the base end side large diameter part 312 may be formed.
The distal end of the core wire 31 is inserted into an electrode 361 (distal electrode) and fixed by solder or the like, and the proximal end of the core wire 31 is fixed to the proximal end of the metal shaft 37, for example.

The outer diameter of the small diameter portion 311 on the distal end side of the core wire 31 is, for example, 0.01 to 0.15 mm, preferably 0.04 to 0.08 mm.
Further, the outer diameter of the base end side large diameter portion 312 of the core wire 31 is, for example, 0.10 to 0.20 mm, and preferably 0.12 to 0.16 mm.

The constituent material of the core wire 31 is not particularly limited, but may include stainless steel (for example, SUS316, SUS304), gold, platinum, aluminum, tungsten, tantalum or alloys thereof, Ni-Ti, and the like. The metal surface may be resin-coated.
Here, stainless steel can be cited as a suitable constituent material of the core wire 31.

A coil spring 33 is attached to the most distal portion (tip-side small diameter portion 311) of the core wire 31 along the axial direction of the core wire 31.
The coil outer diameter of the coil spring 33 is preferably 0.76 mm or less, and is 0.36 mm (0.014 inch) as a suitable example.
The length of the coil spring 33 is, for example, 5 to 30 mm, and preferably 8 to 15 mm.
Although it does not specifically limit as a constituent material of the coil spring 33, Stainless steel (for example, SUS316, SUS304) etc. can be mentioned, The surface of the coil spring 33 may be resin-coated.

  The distal end of the coil spring 33 is fixed to the core wire 31 by an adhesive that forms the insulating member 342, and the rear end of the coil spring 33 is fixed to the distal ends of the core wire 31 and the resin shaft 35 by a resin material that forms the strain relief 345. Has been.

  With the structure of the core wire 31 and the coil spring 33 as described above, the flexibility, bending rigidity, and torque transmission required for the guide wire can be ensured, and the operability as a guide wire can be satisfied.

  The distal end portion (base end side large diameter portion 312) of the core wire 31 excluding the most distal end portion to which the coil spring 33 is attached is enclosed by the resin shaft 35.

  The resin shaft 35 constituting the electrode-equipped guide wire 30 is a multi-lumen structure having a central lumen 350 and six sub-lumens 351 to 356 arranged at intervals of 60 ° around the central lumen 350.

  In the resin shaft 35, the central lumen 350 and the sub-lumens 351 to 356 are formed in an inner portion 357 made of, for example, a low-hardness nylon elastomer. Moreover, the outer peripheral surface of the inner part 357 which has these lumens 350-356 is coat | covered with the outer part 359 which consists of a highly rigid nylon elastomer, for example.

The outer diameter of the resin shaft 35 can be inserted into the guide wire lumen 42 of the balloon catheter 40, and is 0.89 mm or less from the viewpoint of securing an ethanol flow path (gap) even when the resin shaft 35 is inserted. It is preferable that it is 0.64 mm (0.025 inch).
The length of the resin shaft 35 is, for example, 10 to 40 mm, and preferably 15 to 25 mm.

The diameter of the central lumen 350 formed on the resin shaft 35 is, for example, 0.13 to 0.20 mm, and preferably 0.15 to 0.18 mm.
Further, the diameter of the sub-lumens 351 to 356 formed on the resin shaft 35 is, for example, 0.10 to 0.20 mm, and preferably 0.12 to 0.16 mm.

  The proximal end side large diameter portion 312 of the core wire 31 is inserted through the central lumen 350 of the resin shaft 35.

The resin shaft 35 is connected to the metal shaft 37 by inserting the inner portion 357 exposed by peeling the outer portion 359 at the rear end portion into the opening of the metal shaft 37.
The metal shaft 37 constituting the electrode-equipped guide wire 30 is a single lumen structure made of stainless steel, Ni—Ti, Cu—Mn—Al alloy or the like.
A connector 39 is connected to the rear end side of the metal shaft 37.

The outer diameter of the metal shaft 37 is preferably the same as or slightly smaller than the outer diameter of the resin shaft 35.
The length of the metal shaft 37 is, for example, 800 to 2200 mm, and preferably 1200 to 1600 mm.

Electrodes 361 and 362 for measuring an intracardiac potential (bipolar potential) are attached to the most distal end portion of the core wire 31 on the distal end side from the attachment position of the coil spring 33.
The outer diameters of the electrodes 361 and 362 are both 0.76 mm or less.
Each of the electrodes 361 and 362 is connected to the tip of each of the conductive wires 381 and 382, and each of the conductive wires 381 and 382 is inside the resin shaft 35 (sublumens 351 and 352) and inside the metal shaft 37. And the rear end of each is connected to the connector 39.

Further, ring-shaped electrodes 363, 364, 365, and 366 for measuring an intracardiac potential are mounted on the outer periphery of the resin shaft 35.
Each of the ring-shaped electrodes 363 to 366 is connected to the leading end of each of the conducting wires 383 to 386, and each of the conducting wires 383 to 386 is connected to the inside of the resin shaft 35 (sublumen 353 to 356) and the metal shaft. 37, and the rear end of each is connected to the connector 39.

According to the chemical ablation apparatus of the present embodiment, the ethanol injection method into the Marshall vein (VOM) can be performed by the following procedure.
That is, the guide wire 30 with electrode is inserted to measure the potential, the balloon catheter 40 is inserted into the Marshall vein along the guide wire 30 with electrode, and the balloon catheter 40 is configured without removing the guide wire 30 with electrode. The ethanol is flushed from the tip opening of the inner tube 41 (tip tip portion 47).
Details will be described below.

(1) Insertion of parent guiding catheter:
First, the tip of the parent guiding catheter is engaged with the entrance of the coronary sinus (CS) by an approach from the superior vena cava.
At this stage, an over-the-wire balloon catheter (a balloon catheter different from that constituting the chemical ablation apparatus of this embodiment) is inserted into the lumen of the parent guiding catheter, and the coronary sinus (CS) entrance In addition, the balloon may be expanded and occluded, and the presence or absence of the Marshall vein (VOM) may be confirmed by injecting a contrast medium from the tip of the balloon catheter and imaging the coronary sinus (CS).

(2) Insertion of child guiding catheter:
Next, the child guiding catheter is inserted into the lumen of the parent guiding catheter, and the distal end of the child guiding catheter extended from the distal opening of the parent guiding catheter is positioned in the vicinity of the entrance portion of the Marshall vein (VOM). Let

(3) Insertion of electrode-equipped guide wire 30 (electric potential measurement before treatment):
The guide wire 30 with electrode is inserted into the guide wire lumen 42 of the balloon catheter 40 in advance, and the tip of the guide wire 30 with electrode is pulled out from the opening of the tip portion 47. The electrode-equipped guide wire 30 is operated in a state where both are connected in this way.
The guide wire 30 with electrode 30 and the balloon catheter 40 are inserted into the lumen of the child guiding catheter, and the distal end portion of the guide wire 30 with electrode extending from the distal opening of the child guiding catheter (ring-shaped electrodes 361 to 366 are attached). Is inserted into the Marshall vein (VOM), and potential measurement (pacing mapping) is performed before treatment.
Since the tip of the electrode-equipped guide wire 30 has the same performance as that of a general medical guide wire, the tip can be shaped to give a curved shape or the like. And since it can perform operation similar to a general medical guide wire, the guide wire 30 with an electrode can be guide | induced to a Marshall vein comparatively easily.

(4) Insertion of balloon catheter 40 and ablation treatment:
Next, by inserting the inner tube 41 into the guide wire 30 with electrode, the balloon catheter 40 is inserted into the Marshall vein (VOM) along the guide wire 30 with electrode.

FIG. 16 shows that the child guiding catheter 20 extends from the distal opening of the parent guiding catheter 10, and the balloon catheter 40 extending from the distal opening of the child guiding catheter 20 extends along the guide wire 30 with electrode. , Shows a state of being inserted into a Marshall vein (VOM).
In the state shown in FIG. 16, the tip portion of the resin shaft 35 constituting the electrode-equipped guide wire 30 extends from the tip opening of the inner tube 41 (tip tip portion 47).

Next, in the state shown in FIG. 16, that is, with the electrode-equipped guide wire 30 inserted into the Marshall vein (VOM), the balloon 45 of the balloon catheter 40 is expanded, and then ethanol is added from the side injection tube 65. inject.
The injected ethanol passes from the hemostasis valve 60 through the guide wire lumen 42 of the balloon catheter 40 through which the electrode-equipped guide wire 30 is inserted, and from the distal end opening of the inner tube 41 (the distal end tip portion 47) to the Marshall vein (VOM). In this way, chemical ablation is performed.
In addition, chemical ablation (injection of ethanol) is usually started from the back side where the capillaries are located, and multiple times (3 to 4 times) while moving the balloon catheter stepwise in the direction where the inlet portion is located. It is done separately.

(5) Potential measurement after treatment:
Next, the post-treatment potential measurement (pacing / mapping) is performed using the electrode-equipped guide wire 30 that is still inserted into the guide wire lumen 42 of the balloon catheter 40.
If it is determined that the ablation is insufficient as a result of the potential measurement, the treatment can be resumed immediately.

  According to the chemical ablation apparatus of the present embodiment, the procedure relating to the ethanol injection method into the Marshall vein including the potential measurement before and after the treatment can be performed reliably and simply.

  Further, according to the chemical ablation apparatus of the present embodiment, the movement operation (including insertion / extraction operation) of the electrode-equipped guide wire 30 in the guide wire lumen 42 of the balloon catheter 40 is not hindered, and the balloon catheter 40 Can follow a complicated blood vessel shape and can be easily inserted into such a blood vessel.

DESCRIPTION OF SYMBOLS 10 Parent guiding catheter 20 Child guiding catheter 30 Guide wire with electrode 31 Core wire 311 Core wire distal end side small diameter portion 312 Core wire proximal end large diameter portion 33 Coil spring 341, 342 Insulating member 345 Strain relief 35 Resin shaft 350 Central lumen 351-356 Sublumen 357 Inner part 359 Outer part 361, 362 Electrode 363-366 Ring electrode 381-386 Conductor 37 Metal shaft 39 Connector 40, 402-406 Balloon catheter 41, 412-416 Inner tube 417 Contrast marker 42 Guide wire Lumen 43 Outer tube 44 Expansion lumen 45 Balloon 46, 462-466 Base end 47, 472-476 Tip tip 48 Outer layer of the inner layer 49 proximal portion of the parts 50 Y-connector 51 guidewire port 53 expansion port 55 strain relief 60 hemostatic valve 65 side Note tube

Claims (9)

An inner tube having a guide wire lumen through which a guide wire is inserted, an outer tube disposed outside the inner tube to form an expansion lumen, and attached to a distal end of the outer tube and disposed outside the inner tube. An over-the-wire balloon catheter having a balloon,
The inner tube has a relatively rigid base end portion having at least an inner layer formed of a resin having good ethanol resistance, and a relatively rigid distal end tip portion formed of a resin. Become
A balloon catheter, wherein an inner diameter of the distal tip portion is larger than an inner diameter of the proximal end portion.   The balloon catheter according to claim 1, wherein a ratio of an inner diameter of the distal tip portion to an inner diameter of the proximal end portion is 1.02 or more. The difference between the inner diameter of the base end portion and the outer diameter of the guide wire inserted through the guide wire lumen is 0.05 to 0.60 mm,
The balloon catheter according to claim 1 or 2, wherein a difference between an inner diameter of the distal tip portion and an inner diameter of the proximal end portion is 0.02 mm or more.   The balloon catheter according to any one of claims 1 to 3, wherein a joint portion between the proximal end portion and the distal tip portion is located inside the balloon.   The balloon catheter according to any one of claims 1 to 4, wherein an outer diameter of the distal tip portion is equal to an outer diameter of the proximal end portion. The base end portion is constituted by a two-layer tube composed of an inner layer formed of a resin having good ethanol resistance and an outer layer formed of a resin,
The balloon catheter according to any one of claims 1 to 5, wherein the distal tip portion is constituted by a single-layer tube made of the same resin as a constituent resin of the outer layer of the proximal end portion.   The balloon according to claim 6, wherein the constituent resin of the outer layer of the base end part and the constituent resin of the tip part is a polyether block amide copolymer, and the constituent resin of the inner layer of the base end part is polyimide. catheter.   The balloon catheter according to any one of claims 1 to 7, wherein the guide wire is an electrode-equipped guide wire capable of measuring an intracardiac potential. A guide wire with electrodes;
A balloon catheter according to claim 8;
A Y-shaped connector having a guide wire port and an expansion port;
A chemical ablation apparatus comprising a hemostasis valve connected to a guide wire port of a Y-shaped connector and having a side injection tube for supplying ethanol to the guide wire lumen.

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