JP2002355309A - Expansible balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an expansible balloon catheter capable of simplifying the insertion technique of an endoscope in diagnosis or treatment using the endoscope. SOLUTION: In the expansible balloon catheter constituted of a shaft having at least one main lumen piercing in the length direction thereof and at least one sub-lumen, a balloon and a distal end tube, a guide part having a first lumen through which a guide wire can slide and the second lumen communicating with the main lumen is provided to the front part of the balloon and the first lumen is provided on the same axial line as the longitudinal axial line of the catheter.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a dilatation balloon catheter for dilating a stenosis or occlusion of a living body lumen.

[0002]

2. Description of the Related Art Dilatation balloon catheters are used in a variety of medical procedures, and are used to dilate occlusions and stenosis in body lumens. For example, dilatation balloon catheters are used in angioplasty to dilate the lumen of blood vessels that are constricted or stenotic due to arteriosclerosis, as well as in recent years, endoscopic procedures called ureteroscopes or pyeloscopes. In the diagnosis of neoplastic lesions in the ureter or renal pelvis using a scope or in the treatment of ureteral stones, it is frequently used when an endoscope is inserted into the ureter.

Here, a general conventional technique for inserting an endoscope called a ureteroscope or renal pelvic ureteroscope using a dilatation balloon catheter into the ureter and the renal pelvis transurethrally will be described. First, using a ureteral catheter or the like transurethrally, only the guide wire is placed in the ureter, and then the endoscope is inserted transurethrally under the guide wire, and the ureter located in the bladder Into the ureteral opening, which is the entrance of At this time,
If the endoscope does not enter the ureteral ostium, the endoscope alone is removed from the body with the guidewire indwelled, and then the ureteral ostium is dilated with a dilatation balloon catheter under the guidewire.

After expansion, the dilatation balloon catheter is removed from the body while the guide wire is kept in the ureter.
The endoscope is inserted from the ureteral opening into the ureter under the guide wire. However, since the ureter has many physiological stenosis, it is frequently encountered that the endoscope cannot be inserted deeply. In this case, as in the case of dilatation of the ureter, the guide wire is placed in the ureter and the endoscope is pulled out of the body. After that, the dilatation balloon catheter is put on the guide wire under fluoroscopy, and the dilatation balloon catheter is arranged up to just before the stenosis.

Next, in order to confirm the stenosis state under X-ray fluoroscopy, a contrast medium is injected into the stenosis using a dilatation balloon catheter. For this purpose, a guide wire is removed from the dilatation balloon catheter to the outside of the body. Must. Because, in the conventional dilatation balloon catheter,
This is because the lumen for sliding the guide wire and the lumen for injecting the contrast agent have the same structure. After confirming the state of the stenosis, the guide wire is inserted through the dilatation balloon catheter again, and then the balloon portion of the dilatation balloon catheter is placed in the stenosis under the guide wire to expand the stenosis.

[0006] Finally, the dilatation balloon catheter is pulled out of the body while leaving the guide wire in the ureter, and the dilatation procedure for the stenosis is completed. The endoscope is inserted under the guide wire again, Conduct diagnosis and treatment. Therefore, in the conventional dilatation balloon catheter, the contrast agent cannot be injected unless the guide wire is once pulled out.
There has been a problem that the insertion procedure of the endoscope using the dilatation balloon catheter becomes remarkably complicated and burdens both the operator and the patient.

[0007] Japanese Patent No. 2812713 discloses an dilatation balloon catheter having a structure in which a guide wire can slide in a front portion of the balloon. In this structure, the guide wire is inserted through the dilatation balloon catheter. It is possible to inject a contrast agent. However, in the above structure, in angioplasty using a dilatation balloon catheter, dilation may be insufficient with one dilatation balloon catheter. For the purpose of disposing the guide wires at positions adjacent to each other, a passage through which the guide wire can slide is provided on an axis deviated from the longitudinal axis of the catheter. For this reason, when the dilatation balloon catheter is inserted under the guide wire, the pushing force from the hand escapes in the lateral direction, so that the transmissibility, that is, the pushability becomes poor, and there is a problem that the insertion becomes difficult. Was.

[0008]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a dilatation balloon catheter which can simplify an endoscope insertion procedure in diagnosis and treatment using an endoscope.

[0009]

That is, the present invention provides:
(1) In a dilatation balloon catheter composed of a shaft having at least one main lumen and at least one sub lumen penetrating in the length direction, a balloon, and a distal tube, a guide wire slides in front of the balloon. Dilatation having a guide having a first lumen and a second lumen in communication with the main lumen, wherein the first lumen is provided coaxially with the longitudinal axis of the catheter. The balloon catheter, (2) the dilatation balloon catheter according to (1), wherein the guide has a reinforcement, and (3) the dilatation balloon catheter according to (2), wherein the reinforcement is a superelastic metal.

[0010]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to embodiments. FIG. 1 is a view schematically showing a dilatation balloon catheter according to one embodiment of the present invention. FIG. 2 is a view showing a circumferential cross section of AA ′ of the dilatation balloon catheter in FIG. 1, and FIG. 3 is a view showing a circumferential cross section of BB ′ of the dilatation balloon catheter in FIG. Further, FIG. 4A is a diagram showing a circumferential cross section of a guide portion of the dilatation balloon catheter according to one embodiment of the present invention,
(B) is a figure which shows the axial cross section of the guide part of the dilatation balloon catheter which becomes one Example of this invention. FIG.
(A) is a figure which shows the circumferential cross section of the guide part of the dilatation balloon catheter which becomes another Example of this invention, (b)
FIG. 7 is a view showing an axial cross section of a guide portion of a dilatation balloon catheter according to another embodiment of the present invention. FIG. 6 is a view showing a circumferential section of a guide portion of a dilatation balloon catheter according to still another embodiment of the present invention.

In the dilatation balloon catheter shown in FIGS. 1, 2 and 3, the balloon (1) is airtightly joined at two parts on the catheter tube.
The catheter tube has a shaft (2) having one main lumen (4) penetrating in the axial direction, a shaft (2) having at least one sub lumen (5), and a tip having one lumen (8) penetrating in the axial direction. It is formed from a tube (3). The proximal joint (6) of the balloon (1) is attached near the distal end of the shaft (2), and the distal joint (7) of the balloon (1) is connected to the distal tube (3). ).

The joint between the shaft (2) and the distal tube (3) is in the balloon (1) and sends inflation fluid into the balloon (1) through the secondary lumen (5) of the shaft (2). Can be. The main lumen (4) of the shaft (2) communicates with the lumen (8) of the distal tube (3). The dilatation balloon catheter according to the present invention is provided with tantalum, gold, and the like at an appropriate position on the distal tube (3) in the balloon (1) for the purpose of easily confirming the position of the balloon (1) under fluoroscopy. A radiopaque marker (9) such as a ring made of a radiopaque metal such as platinum may be provided. Further, in order to improve the pushability of the catheter tube, a stylet made of stainless steel, superelastic metal or the like may be provided.

According to the present invention, FIG. 1 and FIG.
As shown in FIG. 4 (b), FIG. 5 (a), and FIG. 5 (b), in front of the balloon (1) of the dilatation balloon catheter,
A guiding portion (1) having a first lumen (11) through which a guide wire can slide and a second lumen (12) into which a contrast agent or the like can be injected.
0). Since the first lumen (11) which can slide the guide wire is located on the same axis as the longitudinal axis of the catheter, the pushing force from the hand side does not escape when the catheter is inserted under the guide wire, and the pushability is improved. And the catheter can be inserted without any problem.

Since the second lumen (12) communicates with the lumen (8) of the distal tube (3), there is no need to remove the guide wire from the catheter even when a contrast medium is used. . By using a contrast agent under the guide wire, even if the guide wire itself is difficult to penetrate into the stenosis, the guide wire can be operated immediately after the stenosis is slightly released by injection of the contrast agent, making it easy to operate. It can be inserted. Furthermore, unlike the conventional dilatation balloon catheter, the dilatation balloon catheter according to the present invention does not pass the guide wire through the entire catheter, so that the insertion and withdrawal operation under the guide wire becomes easy. Therefore, the insertion procedure of the ureteroscope and the renal pelvic ureteroscope can be remarkably simplified as compared with the conventional dilatation balloon catheter.

In the guiding portion (10), the first lumen (1)
As a structure in which 1) is located coaxially with the longitudinal axis of the catheter, as shown in FIGS. 4A and 4B, a distal tube (3) located coaxially with the longitudinal axis of the catheter.
Can be created by setting the lumen near the tip of the first lumen as the first lumen (11) that can slide the guide wire. In this case, the second lumen (12) for injecting the contrast agent can be manufactured using insert molding, a heat-shrinkable tube, or the like in a state where the second lumen (12) is displaced from the longitudinal axis of the catheter.

In order to prevent the contrast agent from flowing out from the guide wire outlet (13), it is preferable to provide a sealing body (14), and the sealing body (14) is made of an appropriate adhesive or the like. can do. Further, for the purpose of simplifying the manufacturing method, as shown in FIGS. 5A and 5B, a tube having a plurality of lumens centered on the first lumen (11) is replaced with a distal tube ( 3) can also be connected,
In this case, it is also preferable to have the sealing body (14).

The guiding portion (10) has a second lumen (1) serving as a lumen of a contrast medium when a catheter is inserted under a guide wire.
For the purpose of reliably preventing the kink from kinking and deteriorating the resistance to the injection of the contrast agent, it is preferable to provide a reinforcing body (15) as shown in FIG. Reinforcement (1
Although not shown, 5) extends in the axial direction over substantially the entire area of the guide portion (10). Further, as a material of the reinforcing body (15), a wire made of a superelastic metal or the like such as stainless steel or nitinol (nickel-titanium alloy) is preferable. Elastic metals are particularly preferred.

The outer diameter of the guiding portion (10) is preferably at least equal to or less than the bulk of the balloon (1) when the balloon (1) is wound, and is preferably 0.5 to 3 times.
mm. Further, the length of the guiding portion (10) is preferably 5 to 50 mm. In the guiding part (10),
For the purpose of improving the insertability, a hydrophilic polymer may be applied or a Teflon (R) coating may be applied. In addition, for the purpose of confirming the position under X-ray fluoroscopy, an X-ray such as tantalum, gold, platinum, etc.
A radiopaque metal ring or a contrast material such as bismuth oxide or bismuth subcarbonate may be provided.

The balloon (1) can be formed by a cold parison method in which a parison tube made of a polymer material such as PET or nylon is blow-molded. Is preferably tapered. The balloon (1) may have a two-layer structure by applying, for example, a hydrophilic polymer solution to the surface of the blow-molded balloon for the purpose of improving scratch resistance and insertability. Further, in order to improve the anti-slip property from the stenosis portion, for example, a polymer solution containing fine particles is applied as an outer layer to the surface of the balloon to form a two-layer balloon, or the axial length of the balloon is reduced. On the other hand, physical unevenness may be provided by providing a ring-shaped rib in a circumferential direction orthogonal to the above.

The outer diameter of the balloon (1) is preferably 3 to
It is 7 mm, more preferably 4 to 6 mm. The appropriate outer diameter of the balloon (1) when expanding the stenosis or occlusion is generally the inner diameter of the living body lumen before stenosis or occlusion, and the inner diameter of the ureter is generally 3 to 7 mm. If the balloon outer diameter is within this range, the necessary treatment can be performed almost. The effective length of the balloon (1) is preferably from 20 to 100 mm, more preferably from 40 to 80 mm. When the length is shorter than 20 mm or longer than 100 mm, it is difficult to dispose the balloon (1) in the stenosis, which is not preferable.

[0021] Shaft (2) and tip tube (3)
For example, for example, a nylon composite material, a polyurethane composite material, or a polyethylene composite material can be formed by extrusion molding, and for the purpose of providing a contrast property, for example, a contrast material such as bismuth oxide or bismuth subcarbonate is used. They can be combined. The outer diameter of the shaft (2) is
1.0-3.0 mm is preferable in order not to deteriorate the insertability into the ureter and to maintain a lumen that allows the balloon inflation fluid and the contrast agent to pass through without difficulty. The outer diameter of the tip tube (3) is preferably smaller than the shaft, and preferably 0.5 to 2.5 mm, in order to reduce the bulk when the balloon (1) is wound.
In addition, the length of the dilatation balloon catheter is preferably at least longer than the length from the urethral opening to the renal pelvis junction, and is preferably 50 to 150 cm, so that the dilatation procedure can be performed transurethrically to the renal pelvis and ureter junction.

[0022]

As is clear from the above, the dilatation balloon catheter according to the present invention is extremely useful as a medical device capable of simplifying the endoscope insertion procedure in diagnosis and treatment using an endoscope. is there.

[Brief description of the drawings]

FIG. 1 is a view schematically showing a dilatation balloon catheter according to one embodiment of the present invention.

FIG. 2 is a view showing a cross section in the circumferential direction at AA ′ of the dilatation balloon catheter according to one embodiment of the present invention.

FIG. 3 is a diagram showing a cross section in the circumferential direction at BB ′ of the dilatation balloon catheter according to one embodiment of the present invention.

FIGS. 4A and 4B are views showing a guide portion of a dilatation balloon catheter according to one embodiment of the present invention, wherein FIG.
(B) is a sectional view in the axial direction.

5A and 5B are views showing a guide portion of a dilatation balloon catheter according to another embodiment of the present invention, wherein FIG. 5A is a sectional view in a circumferential direction, and FIG. 5B is a sectional view in an axial direction.

FIG. 6 is a circumferential sectional view of a guide portion of a dilatation balloon catheter according to still another embodiment of the present invention.

[Explanation of symbols]

 1. Balloon 2. Shaft 3. Tip tube 4. Main lumen 5. Minor lumen 6. Proximal junction 7. 7. distal junction 8. Lumen (of tip tube) Contrast markers 10. Guidance part 11. First lumen 12. Second lumen 13. Guide wire outlet 14. Sealed body 15. Reinforcement

Claims (3)

[Claims] 1. A dilatation balloon catheter comprising a shaft having at least one major lumen and at least one minor lumen penetrating in a longitudinal direction, a balloon, and a distal tube, wherein a guide wire is provided in front of the balloon. It has a guide portion having a slidable first lumen and a second lumen communicating with the main lumen, wherein the first lumen is provided coaxially with the longitudinal axis of the catheter. Dilatation balloon catheter. 2. The guide portion is provided with a reinforcing member.
A dilatation balloon catheter as described. 3. The dilatation balloon catheter according to claim 2, wherein the reinforcing member is a superelastic metal.