JP7305152B2 - balloon catheter - Google Patents

Description

TECHNICAL FIELD The present invention relates to a balloon catheter having a basket structure for trapping foreign substances in the human body such as gallstones and kidney stones.

Patent Document 1 discloses a basket-type treatment instrument for removing foreign matter such as calculus that has occurred in the body. It is described that a balloon is attached to the part.

When performing endoscopic large-diameter papilla balloon dilatation (EPLBD) with the basket-type treatment instrument of Patent Document 1, the balloon can be used to expand the duodenal papilla and dilate the bile duct to sufficiently expand the basket. However, there was a problem that the balloon easily slipped against the papilla and the inner wall of the bile duct. In addition, since the basket is attached to the distal end of the operation wire, it is necessary to protrude the basket from the catheter tube after dilating the papilla and bile duct with the balloon, lengthening the operation time and placing a burden on the patient. I had a problem with it.

JP 2006-304835 A

The present invention has been made in view of the above-mentioned problems, and the balloon does not slip easily against the inner wall of the papilla and bile duct, the expansion operation of the basket is unnecessary, and the operation time can be shortened and the burden on the patient can be reduced. An object of the present invention is to provide a balloon catheter.

The first means for solving the above problems is
a catheter shaft having a first lumen and a second lumen;
Both ends are fixed on the distal end side of the catheter shaft so as to cover the outer peripheral surface of the catheter shaft, and expands by introducing fluid into the inner space through the first lumen and discharges the fluid. a balloon that deflates by
a basket structure having a distal end secured to the catheter shaft distal to the balloon and an open proximal end;
The balloon extends in the longitudinal direction of the catheter shaft, is fixed to the catheter shaft on either one of the proximal end side and the distal end side of the balloon, and is slidably provided on the catheter shaft on the other side. a plurality of linear surface structures provided along the outer surface of the balloon when inflated;
A balloon catheter comprising:
Preferably, the proximal end of the balloon is located between the distal end of the inflated maximum diameter portion of the balloon and the distal fixed end of the balloon.

In the first means, since a plurality of linear surface structures are provided along the outer surface of the balloon when the balloon is inflated, the balloon does not slip easily against the papilla and the inner wall of the bile duct. In addition, the basket structure provided on the distal end side of the balloon expands at the proximal end when the balloon is inflated, and when the balloon is contracted, it becomes possible to trap foreign matter such as gallstones. There is no need to insert and withdraw from the distal end of the catheter shaft, shortening the operation time and reducing the burden on the patient.

In a second means, said basket structure is shaped like a cone or pyramid from the proximal end to the distal end.
Therefore, by pulling the catheter shaft toward the proximal end side, foreign matter such as gallstones can be received and captured from the open proximal end of the basket structure.

According to a third measure, said basket structure is formed in a mesh.
As a result, foreign objects such as calculus can be captured, but the fluid in the bile duct can be passed through, reducing the resistance when the catheter shaft is pulled back, thereby facilitating recovery of foreign objects such as calculus.

In a fourth means, the basket structure may be cap-shaped. For this reason, even small stones can be supplemented.

In a fifth means, the balloon forms a plurality of radial vanes when deflated. Thus, multiple vanes can be wrapped around the catheter shaft and stored.

In a sixth means, the proximal end of said basket structure is supported by the tips of said plurality of vanes when said balloon is deflated.
Therefore, when the balloon is deflated, the proximal end of the basket structure is supported by the distal ends of the plurality of blades, so that the proximal end of the basket structure is in an open state, thereby reliably trapping foreign matter such as calculus. be able to.

According to the present invention, since a plurality of linear surface structures are provided along the outer surface of the balloon when the balloon is inflated, the balloon is prevented from slipping against the papilla and the inner wall of the bile duct. In addition, the basket structure provided on the distal end side of the balloon makes it possible to trap foreign matter such as gallstones as soon as the balloon is deflated. It is not necessary, and has the effect of shortening the operation time and reducing the burden on the patient.

1 is a perspective view showing the entire balloon catheter according to a first embodiment of the present invention; FIG. 2 is an enlarged perspective view of the balloon portion of the balloon catheter of FIG. 1 during inflation; FIG. FIG. 2 is a longitudinal sectional view (a) and a lateral view (b) of the balloon catheter of FIG. 2 when inflated. FIG. 3A is a side view (a) of the balloon catheter in FIG. Va-Va line enlarged cross-sectional view (a) in FIG. 3(b), Vb-Vb line enlarged cross-sectional view (b) in FIG. 4(a), Vc-Vc line enlarged cross-sectional view (c) in FIG. 4(b) ). FIG. 10 is a cross-sectional view showing how the basket structure is expanded by the wires of the surface structure when the balloon is inflated. Side view (a) showing the shape before attachment of the surface structure with the fixing sleeve split in half, and side view (b) showing the state in which the surface structure is split into two surface structures, the first and the second. ). FIG. 10 is a perspective view showing how the surface structure and basket structure are attached to the catheter shaft; FIG. 4 is a cross-sectional view showing a method of forming vanes on a balloon; Schematic diagram of the human bile duct circumference showing the capture of gallstones in the bile duct. Sectional view showing a procedure for trapping gallstones in the bile duct. FIG. 12 is a cross-sectional view showing the procedure for capturing gallstones in the bile duct subsequent to FIG. 11; FIG. 4 is a perspective view of the balloon catheter according to the second embodiment of the present invention when the balloon is inflated. FIG. 11 is a perspective view of the balloon catheter according to the third embodiment of the present invention when the balloon is inflated;

Next, embodiments of the present invention will be described with reference to the accompanying drawings.

<First embodiment>
FIG. 1 shows a balloon catheter 1 according to a first embodiment of the invention. Balloon catheter 1 has an elongate tubular catheter shaft 2 insertable through a channel of an endoscope into a bile duct of the human body. The catheter shaft 2 has a double tube structure consisting of an inner tube 3 and an outer tube 4, as shown in FIG. The inner tube 3 and the outer tube 4 are made of polyamide-based, polyethylene-based, polypropylene-based, polyurethane-based, or polyimide-based resin. The interior of the inner tube 3 forms a first lumen 5 and between the inner tube 3 and the outer tube 4 forms a second lumen 6 . The outer diameter of the catheter shaft 2 is selected according to the diameter of the bile duct to be inserted, preferably 0.3 to 10 mm.

A connector hub 7 is provided on the proximal end side of the catheter shaft 2 as shown in FIG. The connector hub 7 has a guide wire insertion port 8 communicating with the first lumen 5 of the inner tube 3, a balloon inflation fluid inlet 9 communicating with the second lumen 6 between the inner tube 3 and the outer tube 4, and a cock 9a. , a contrast agent inlet 10 communicating with the first lumen 5 of the inner tube 3 is provided.

At the distal end side of the catheter shaft 2, the inner tube 3 protrudes distally beyond the outer tube 4, as shown in FIG. A balloon 11 is provided between the distal end of the inner tube 3 and the distal end of the outer tube 4 . The proximal end of balloon 11 is fixed to the distal end of outer tube 4 and the distal end of balloon 11 is fixed to the distal end of inner tube 3 . As a result, the balloon 11 is inflated by introducing the balloon inflation fluid through the second lumen 6 between the inner tube 3 and the outer tube 4, and deflated by discharging the fluid. ing. The inner tube 3 on the distal side of the balloon 11 serves as a distal tip 3a. The proximal and distal ends of balloon 11 are fixed by heat welding or adhesive.

The balloon 11 is formed by biaxial stretch blow molding so that when inflated, the proximal end side and the distal end side are conical portions 11a and 11b, and the intermediate portion is a cylindrical portion 11c. Moreover, as shown in FIG. 5(b), the balloon 11 is shaped so that three radial blades 12a, 12b, 12c are formed when deflated. The method of forming the habit will be described later in detail in the description of the manufacturing method. The wings 12a, 12b, and 12c can be wrapped around the inner tube 3 of the catheter shaft 2 and folded, as shown in FIG. 5(c). The number of blades is not limited to 3, but preferably 2 to 6 depending on the number of wires of the surface structure 14, which will be described later. For example, if the number of wires in the surface structure 14 is six, the number of blades may be three or six. When the blade is folded, it is not bulky and has a small diameter, which is advantageous in that it can be easily passed between the papilla, bile duct, and gallstone in the operation described later.

The balloon 11 is made of a flexible material such as polyamide-based, polyethylene-based, polypropylene-based, polyurethane-based, polyimide-based resin, silicon rubber, natural rubber, or the like. The outer diameter of the balloon 11 when inflated is selected according to the diameter of the bile duct to be inserted, preferably 1 to 20 mm. Also, the length of the balloon 11 is preferably 5 to 40 mm.

The catheter shaft 2 is further provided with a basket structure 13 and a surface structure 14, as shown in FIG. These will be described below.

The basket structure 13 is formed in a conical or triangular pyramidal shape from the proximal end to the distal end and has meshes of 3-5 mm. The stitch shape may be rectangular or rhombic. The proximal end of the basket structure 13 is open, and as shown in FIG. , and the distal end (B) of the cone portion 11b, which is the distal fixed end. This is to prevent the proximal end portion of the basket structure 13 from being wrapped around when the cylindrical portion 11c of the balloon 11 is wound, thereby preventing the outer diameter profile from becoming large. The distal end of the basket structure 13 is heat-sealed to a fixing sleeve 15, which is fixed to the distal tip 3a of the inner tube 3 by heat-sealing or adhesive.

The basket structure 13 is flexible and made of filaments such as polymers such as polyamide-based, butadiene-based, urethane-based, and silicon-based polymers and copolymers, stainless steel, nickel-titanium alloys, and carbon fibers. ing. The basket structure 13 may be made by knitting or weaving fibers made of these materials, or may be made by perforating a sheet material. The basket structure 13 is flexible so that the proximal end can be opened and closed like an umbrella and can be wrapped around the inner tube 3 of the catheter shaft 2 and collapsed. ing. Basket structure 13 is preferably plastically deformable and capable of being held open and folded.

The surface structure 14 extends in the longitudinal direction of the catheter shaft 2 and, as shown in FIG. 5, is formed of a plurality of (six in the embodiment) linear wires 14a to 14f arranged at regular intervals in the circumferential direction. ing. As shown in FIG. 3, the proximal ends of wires 14a-14f are heat-sealed to slide sleeve 16a, which is longitudinally slidably mounted on outer tube 4 of catheter shaft 2. As shown in FIG. The distal ends of the wires 14a-14f are heat-sealed to a fixing sleeve 16b, which is fixed to the distal tip 3a of the inner tube 3 by heat-sealing or adhesive. The surface structure 14 is provided along the outer surface of the balloon 11 when the balloon 11 is inflated. The slide sleeve 16a moves along the outer tube 4 as the balloon 11 is inflated so that the surface structure 14 follows the inflation of the balloon 11. As shown in FIG. Also, before the balloon 11 is fully inflated, the slide sleeve 16a abuts against the proximal end of the balloon 11 to constrain movement, thereby applying tension to the wires 14a-14f, as shown in FIG. , and wires 14a to 14f.

Like the basket structure 13, the surface structure 14 has flexibility and is made of polymers such as polyamide-based, butadiene-based, urethane-based, and silicon-based polymers and copolymers, stainless steel, nickel-titanium alloys, It is made of filaments such as carbon fiber. The wires 14a to 14f of the surface structure 14 preferably have a circular, triangular, trapezoidal or quadrangular cross-sectional shape and an outer diameter of 0.1 to 5 mm.

When the wings 12a, 12b, and 12c of the balloon 11 of the balloon catheter 1 are wrapped around the inner tube 3 of the catheter shaft 2 and folded, the surface structure 14 is sandwiched between the wings 12a, 12b, and 12c, and the basket structure 13 is folded. Fold the proximal end (see FIG. 4(b)). The folded balloon 11, basket structure 13 and surface structure 14 are preferably covered with a protective tube 17 shown in FIG.

Next, a method for manufacturing the balloon catheter 1 of the first embodiment will be described.

First, the sleeve 16b for fixing on the distal side of the surface structure 14 is split in half as shown in FIG. It is slidably held at a position away from the distal end of the outer tube 4 of the catheter shaft 2 . Subsequently, the catheter shaft 2 is inserted into the balloon 11 which is biaxially stretched and blow-molded to form wings 12a, 12b, and 12c by a method described later, and the proximal end of the balloon 11 is adhered or bonded to the distal end of the outer tube 4. It is fixed by welding, and the distal end of the balloon 11 is fixed to the inner tube 3 by gluing or welding.

Slide tube 16a on the proximal side of surface structure 14 is moved to the vicinity of the proximal end of balloon 11, and wires 14a-14f are attached to vanes 12a, 12b, 12c of balloon 11 two by two, as shown in FIG. place in between. The half fixing sleeve 16b on the distal side of the surface structure 14 is fitted to the outer peripheral surface of the inner tube 3, and the opposing end faces of the half fixing sleeve 16b are joined by adhesion or welding to form a circular tube. At the same time, the fixing sleeve 16b is fixed to the inner tube 3 by adhesion or welding.

Subsequently, as shown in FIG. 8 , the inner tube 3 of the catheter shaft 2 is inserted from the proximal end of the basket structure 13 into the fixing sleeve 15 so that the proximal end of the basket structure 13 is connected to the cylindrical portion of the balloon 11 . It is positioned between the distal end (A) of 11c and the distal end (B) of conical portion 11b (see FIG. 3(a)). In this state, the fixing sleeve 15 of the basket structure 13 is fixed to the tip 3a of the inner tube 3 by adhesion or welding. Thus, a balloon catheter 1 as shown in FIG. 3(a) is obtained.

Finally, the wire wires 14a-14f of the surface structure 14 are wrapped between the wings 12a, 12b, 12c of the balloon 11 to wrap the wings 12a, 12b, 12c around the inner tube 3 of the catheter shaft 2, and the basket structure The proximal end of 13 is similarly wrapped around the inner tube 3 of the catheter shaft 2 and inserted into the protective tube 17 in this state.

7(a), instead of dividing the distal fixing sleeve 16b in half, as shown in FIG. A first surface structure 14' having wires 14a, 14c and 14e attached thereto, and a second surface structure 14'' having three wires 14b, 14d and 14f attached to a fixing sleeve 16b. In this case, the first surface structure 14' is inserted into the catheter shaft 2 before attaching the balloon 11 to the catheter shaft 2, and the second surface structure 14' is inserted after the balloon 11 is attached to the catheter shaft 2. The structure 14'' is inserted into the inner tube 3 to fix the wires 14b, 14d, 14f of the second surface structure 14'' to the slide tube 16a and the wires 14a, 14c of the first surface structure 14'. , 14e to the fixing sleeve 16b.

A method of forming vanes 12a, 12b and 12c on balloon 11 will be described.
Air is injected into the balloon 11 that has been biaxially stretched and blow-molded so that the balloon 11 is inflated. Subsequently, the balloon 11 is inserted into a pressing device 30 comprising three pressing members 31, 32 and 33 as shown in FIG. 9(a).

The three pressing members 31, 32, and 33 of the pressing device 30 are configured to be synchronously movable in the radial direction of the balloon 11 (indicated by arrows in FIG. 9). The first pressing member 31 and the second pressing member 32 of the pressing device 30 are formed with facing surfaces 31a and 32b forming the blades 12a, and the second pressing member 32 and the third pressing member 33 are formed with the blades 12b. The third pressing member 33 and the first pressing member 31 are provided with opposing surfaces 33a and 31b forming the blades 12c. Pressing portions 31c, 32c, and 33c for pressing the outer surface of the balloon 11 are formed in the first pressing member 31, the second pressing member 32, and the third pressing member 33, respectively.

While the balloon 11 is pressed from the outside by the pressing portions 31c, 32c, and 33c of the three pressing members 31, 32, and 33 of the pressing device 30, the air inside the balloon 11 is sucked and the balloon 11 is contracted. In this state, the balloon 11 is heated via the pressing members 31 , 32 , 33 . As a result, as indicated by a two-dot chain line in FIG. 9, the blades 12a are formed on the balloon 11 sandwiched between the opposing surfaces 31a and 32b, the opposing surfaces 32a and 33b, and the opposing surfaces 33a and 31b of the pressing members 31, 32, and 33. , 12b and 12c are formed, and the balloon 11 pressed by the pressing portions 31c, 32c and 33c of the pressing members 31, 32 and 33 is reduced in diameter. The vanes 12 a , 12 b , 12 c of the balloon 11 may be molded while the balloon 11 is attached to the catheter shaft 2 .

Next, a method for capturing and removing gallstones 21 formed in the bile duct 25 leading to the gallbladder 20 using the balloon catheter 1 of the first embodiment and the action of the balloon catheter 1 will be described.

First, as shown in FIG. 10, the endoscope 23 is inserted into the patient's duodenum 22 and the distal end of the endoscope 23 is positioned near the papilla 24 . The protective tube 17 covering the balloon 11 , the basket structure 13 and the surface structure 14 of the balloon catheter 1 of the first embodiment is removed, and the balloon catheter 1 is inserted into the endoscope 23 . When the distal end of the balloon catheter 1 protrudes from the distal end of the endoscope 23 , the balloon catheter 1 is further advanced to insert the tip 3 a at the distal end into the papilla 24 . A contrast agent is introduced from the contrast agent inlet 10 of the balloon catheter 1 so that the inside of the bile duct 25 can be observed from the outside by X-ray fluoroscopy.

Subsequently, the guide wire 26 is inserted through the guide wire insertion opening 8 of the balloon catheter 1, and the distal end of the guide wire 26 is advanced beyond the position of the gallstone 21 as shown in FIG. 11(a). Next, as shown in FIG. 11(b), the balloon catheter 1 is advanced along the guide wire 26 to position the balloon 11 in front of the position of the gallstone 21. Then, as shown in FIG. Since the balloon 11 is in a state in which the three vanes 12 a , 12 b , 12 c are folded, it can pass between the gallstone 21 and the inner wall of the bile duct 25 . Before advancing the balloon catheter 1 beyond the papilla 24, the papilla 24 may be expanded by inflating the balloon 11 (endoscopic papilla large-diameter balloon dilatation: EPLBD).

A fluid is introduced from the balloon inflation fluid inlet 9 of the balloon catheter 1 to inflate the balloon 11 as shown in FIG. 11(c). As the balloon 11 is inflated, the proximal end of the basket structure 13 is pushed from the inside by the wires 14a to 14f of the surface structure 14 on the distal end side of the balloon 11, and the basket structure 13 becomes like an umbrella. Expand.

The position of the basket structure 13 and the position of the gallstone 21 are confirmed, and the balloon 11 is moved in the longitudinal direction or the circumferential direction while adjusting the amount of balloon inflation fluid to move the basket structure to a position where the gallstone 21 can be captured. 13 is placed. In this state, balloon 11 is inflated until its outer surface and surface structure 14 contact the inner wall of bile duct 25 . The proximal end of the basket structure 13 is in contact with the inner wall of the bile duct 25 together with the balloon 11 .

Since the six linear wires 14a to 14f of the surface structure 14 are present on the outer surface of the balloon 11, the wires 14a to 14f bite into the inner wall surface of the bile duct 25, and the balloon 11 moves in the circumferential and longitudinal directions. Slippage is prevented and the position of the balloon 11 is stabilized.

Next, as shown in FIG. 11(d), the balloon inflation fluid is discharged from the balloon 11 to deflate the balloon 11. Then, as shown in FIG. The balloon 11 now has three vanes 12a, 12b, 12c, as shown in FIG. become supported. Therefore, the basket structure 13 maintains the expanded state. When the balloon catheter 1 is retracted in this state, the deflated balloon 11 of the balloon catheter 1 is pulled back toward the papilla 24 through the walls of the gallstone 21 and the bile duct 25, as shown in FIG. 12(a). At this time, the balloon 11 passes between the gallstone 21 and the wall surface of the bile duct 25 while at least one of the three blades 12a, 12b, 12c collapses. As shown in FIG. 12(b), since the basket structure 13 is in an expanded state, the gallstones 21 are captured as the balloon catheter 1 is retracted.

Since the basket structure 13 is mesh-like, it captures the gallstones 21, but allows the fluid in the bile duct 25 to pass through, reducing the resistance when the catheter shaft 2 is pulled back and facilitating the recovery of the gallstones 21. can do. The gallstone 21 trapped in the basket structure 13 can be extracted from the bile duct 25 through the papilla 24 into the duodenum 22, passed through the endoscope 23, and extracted to the outside. If gallstone 21 is larger than the hole in nipple 24 , balloon 11 may be inflated to dilate the hole in nipple 24 as balloon 11 passes through nipple 24 .

<Second embodiment>
FIG. 13 shows a balloon catheter 1A according to a second embodiment of the invention. The balloon catheter 1A of the second embodiment is substantially the same as the balloon catheter 1 of the first embodiment except for the shape of the basket structure 13a. do.

The basket structure 13a of the balloon catheter 1A of the second embodiment does not have a mesh shape as in the first embodiment, but has a conical cap shape with an open proximal end. The basket structure 13a is flexible and made of a sheet of a polymer such as a polyamide-based, butadiene-based, urethane-based, or silicon-based polymer or copolymer, stainless steel, nickel-titanium alloy, carbon fiber, or the like. ing. The basket structure 13a can be folded like an umbrella at its proximal end when the balloon 11 is deflated. Since the cap-shaped basket structure 13a is not a mesh, it has the effect of capturing even fine calculus.

<Third Embodiment>
FIG. 14 shows a balloon catheter 1B according to a third embodiment of the invention. The balloon catheter 1B of the third embodiment is substantially the same as the balloon catheter 1 of the first embodiment, except that the basket structure 13b has a rhombic mesh shape, and corresponding parts are denoted by the same reference numerals. description is omitted. Since the basket structure 13b has a rhomboidal mesh shape, it can be easily opened and narrowed.

The present invention is not limited to the above embodiments, and modifications and changes can be made without changing the gist of the invention described in the claims.

For example, in the above-described embodiment, the catheter shaft 2 is composed of an inner tube 3 and an outer tube 4, the inside of the inner tube 3 is the first lumen 5, and the space between the inner tube 3 and the outer tube 4 is the second lumen 6. However, a single tube may form the first and second lumens.

Also, in the above embodiment, the surface structure 14 is slidably provided on the outer tube 4 of the catheter tube 2 at its proximal end and fixed to the inner tube 3 of the catheter tube 2 at its distal end. may be fixed to the catheter shaft 2 at the proximal end and slidably provided at the distal end.

DESCRIPTION OF SYMBOLS 1... Balloon catheter 1A... Balloon catheter 1B balloon catheter 2... Catheter shaft 3... Inner tube 3a... Distal tip 4... Outer tube 5... First lumen 6... Second lumen 7... Connector hub 8... Guide wire insertion port 9... Balloon Inflation fluid inlet 10 Contrast medium inlet 11 Balloon 12a, 12b, 12c Blade 13 Basket structure 13a Basket structure 13b Basket structure 14 Surface structure 14a to 14f Wire 15 For fixation Sleeve 16a Slide sleeve 16b Fixing sleeve 17 Protective tube 20 Gallbladder 21 Gallstone 22 Duodenum 23 Endoscope 24 Papilla 25 Bile duct 26 Guide wire 30 Pressing device 31 First pressing member 32 Second pressing member 33... Third pressing member

Claims (4)

a catheter shaft having a first lumen and a second lumen;
Both ends are fixed on the distal end side of the catheter shaft so as to cover the outer peripheral surface of the catheter shaft, and expands by introducing fluid into the inner space through the first lumen and discharges the fluid. a balloon that deflates by
a basket structure having a distal end secured to the catheter shaft distal to the balloon and an open proximal end;
The balloon extends in the longitudinal direction of the catheter shaft, is fixed to the catheter shaft on either one of the proximal end side and the distal end side of the balloon, and is slidably provided on the catheter shaft on the other side. a plurality of linear surface structures provided along the outer surface of the balloon when inflated;
with
The balloon is formed with a plurality of radial vanes when deflated,
A balloon catheter wherein the proximal end of the basket structure is supported by the tips of the vanes when the balloon is deflated . 2. The balloon catheter according to claim 1, wherein the basket structure is formed in a conical or triangular pyramidal shape from the proximal end to the distal end. The balloon catheter according to claim 1 or 2, wherein the basket structure is formed in a mesh shape. The balloon catheter according to claim 1 or 2, wherein the basket structure is cap-shaped.

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