JP6835120B2 - Balloon catheter for IABP - Google Patents

Description

The present invention relates to a balloon catheter for IABP used in the IABP method (intra-aortic balloon pumping method).

Medical catheters include balloon catheters that have a balloon that can be inflated and contracted at the distal end. Intra-aortic balloons are one of the uses of balloon catheters, in which a balloon catheter is inserted into the aorta as a treatment for cardiac dysfunction, and the balloon is inflated and contracted according to the heartbeat to assist cardiac function. There is a pumping method (IABP method).

The IABP balloon catheter used in the IABP method is inserted into an artery from the femoral artery or brachial artery, and is used in a state where the balloon is placed in the descending thoracic aorta. The balloon catheter is inserted into the artery with the balloon wrapped around the catheter tube, but in order to avoid catching in the arterial lumen at the time of insertion and to realize smooth insertion, the balloon catheter is inserted. Good insertability is required.

International Publication No. 2004/071567

In the conventional balloon catheter, when the balloon is wound around the catheter tube, a bulge is generated in the portion connected to the proximal end side of the tip, and the bulge in this portion adversely affects the insertability of the balloon catheter. It was happening.

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a balloon catheter for IABP having good insertability.

In order to achieve the above object, the balloon catheter for IABP according to the present invention is
With a tubular tip and
A catheter tube having a first lumen and a second lumen separated from the first lumen, the first tube portion in which the first lumen is formed internally and the distal end is inserted into the tip. A catheter tube having a second tube portion in which the first lumen and the second lumen are formed and connected to the proximal end of the first tube portion.
A joint portion that is connected to the proximal end of the tip and joins the tip and the first tube portion.
The joint portion and the portion of the first tube portion exposed from the tip tip and the joint portion are housed inside, and the outer periphery of the tip and the outer periphery of the second tube portion. A balloon catheter having a balloon to be fixed,
The joint portion has an adhesive curing portion that joins the proximal end of the tip tip and the outer periphery of the first tube portion exposed from the proximal end of the tip tip.
The balloon is connected to a tubular neck portion fixed to the tip and having a predetermined outer diameter and a proximal end of the neck portion, which is a proximal end of the neck portion, and faces the proximal end side. It has a cone part that expands the outer diameter.
The proximal end of the neck portion is located on the proximal end side of the proximal end of the joint portion, which is the proximal end of the joint portion.

In the conventional balloon catheter for IABP, when the balloon catheter is inserted into an artery, the cone portion of the balloon is wound around the outer circumference of the joint portion that joins the tip tip and the catheter tube, so that this portion is bulged. .. The reason for this is that the cone portion is a portion whose outer diameter expands toward the proximal end side, so that wrinkles are likely to be formed in the wound state, and the film thickness tends to be thicker than the average value of the entire balloon. Etc. are considered to be related. On the other hand, in the balloon catheter according to the present invention, since the tubular neck portion is located on the outer circumference of the joint portion, it is possible to prevent bulging from occurring on the outer circumference of the joint portion and realize good insertability. Can be done.

Further, for example, the catheter tube has an inner tube in which the first lumen is formed and an outer tube through which the inner tube is inserted, and the second lumen is inside the outer tube. It may be formed on the outside of the inner tube.

The catheter tube is not particularly limited as long as it has a first tube portion and a second tube portion, but a catheter tube having an inner tube and an outer tube generally called a coaxial type is preferable. Such a catheter tube is easy to manufacture because it is easy to form a first tube portion having a first lumen, and the bendability is less likely to be directional, resulting in a uniform bendability. Since it has a tendency, it has excellent insertability.

FIG. 1 is a schematic cross-sectional view of a balloon catheter for IABP according to an embodiment of the present invention. FIG. 2 is a schematic side view showing the shape of the distal end portion of the balloon catheter shown in FIG. 1 in an inflated state. FIG. 3 is a schematic view showing the shape of the distal end portion of the balloon catheter shown in FIG. 1 in a wound state. FIG. 4 is a schematic side view showing the shape of the distal end portion of the balloon catheter according to the reference example in the inflated state.

Hereinafter, the balloon catheter for IABP according to the present invention will be described in detail based on the embodiments shown in the drawings.

FIG. 1 is a schematic cross-sectional view of a balloon catheter 10 according to an embodiment of the present invention. The balloon catheter 10 includes a tip tip 20, a catheter tube 40 connected to the tip tip 20, a joint portion 30 joining the tip tip portion 20 and the catheter tube 40, and a balloon fixed to the tip tip 20 and the catheter tube 40. It has a 60 and a bifurcation 70 to which the proximal end of the catheter tube 40 is connected. In the description of the balloon catheter 10, the extending direction of the balloon catheter 10 is the axial direction, the side close to the tip tip 20 is the distal end side, and the side close to the bifurcation portion 70 is the proximal end side.

The tip tip 20 located at the distal end of the balloon catheter 10 has a tubular shape, and a blood flow hole 20c into which blood in an artery flows is formed inside the tip tip 20. The blood flow hole 20c communicates with the first lumen 40c of the catheter tube 40. Further, the distal end of the balloon 60 is fixed to the outer circumference 20d of the tip tip 20. The tip tip 20 is made of a resin material such as polyurethane or nylon, or a metal material such as stainless steel, but the material of the tip tip 20 is not particularly limited. When the tip is made of a resin material, a contrast agent may be contained or a metal may be embedded in order to impart contrast to the tip.

The catheter tube 40 has a first lumen 40c and a second lumen 40d separated from the first lumen, a first tube portion 46 constituting a portion on the distal end side, and a proximal end of the first tube portion 46. It is configured to have a second tube portion 48 connected to the proximal end 46a of the first tube portion. A first lumen 40c is formed inside the first tube portion 46. Further, the distal end 46b of the first tube portion, which is the distal end of the first tube portion 46, is inserted into the blood flow hole 20c of the tip tip 20. The first tube portion 46 is composed of a distal end side portion of the inner tube 52, which is a single lumen tube in which the first lumen 40c is formed.

Inside the second tube portion 48, a first lumen 40c continuing from the first tube portion 46 and a second lumen 40d separated from the first lumen 40c are formed. The second tube portion 48 is composed of a proximal end side portion of the inner pipe 52 and an outer pipe 54 through which the inner pipe 52 inserts the inside. The outer tube 54 is composed of a single lumen tube having an inner diameter larger than the outer diameter of the inner tube 52. The second lumen 40d of the second tube portion 48 is formed inside the outer tube 54 and outside the inner tube 52.

In the catheter tube 40, the proximal end 46a of the first tube portion, which is the proximal end of the first tube portion 46, is thed by a notch 56 provided in the distal end 54b of the outer tube, which is the distal end of the outer tube 54. 2 Fixed to the distal end of tube portion 48. The notch 56 is formed by forming a radial notch 55 near the distal end 54b of the outer tube, and pushing the portion of the notch 55 toward the distal end 54b toward the second lumen 40d. The inner pipe 52 passes through the notch 55 opened by pushing the notch 56 into the second lumen 40d. Therefore, the proximal end 46a of the first tube portion located at the boundary between the portion of the inner pipe 52 inserted into the outer pipe 54 and the portion exposed from the outer pipe 54 is the notch 56 and the inner wall of the outer pipe 54. It is fixed to the distal end of the second tube portion 48 by being sandwiched between the two.

The material of the catheter tube 40 is not particularly limited, but for example, the inner tube 52 is composed of a synthetic resin tube such as polyurethane, polyvinyl chloride, polyethylene, nylon, or polyetheretherketone, a nickel titanium alloy thin tube, a stainless steel thin tube, or the like. To. When the inner tube 52 is made of a synthetic resin tube, a stainless steel wire or the like may be embedded. Further, for example, the outer tube 54 is made of a synthetic resin such as polyurethane, polyvinyl chloride, polyethylene terephthalate, or polyamide, and a stainless steel wire or the like may be embedded therein.

The outer diameter of the inner pipe 52 is not particularly limited, but is preferably 0.5 to 2.0 mm, preferably 30 to 60% of the inner diameter of the outer pipe 54. The outer diameter of the inner pipe 52 is substantially the same along the axial direction. The inner diameter and the wall thickness of the outer tube 54 are not particularly limited, but the inner diameter is preferably 1.5 to 4.0 mm, and the wall thickness is preferably 0.05 to 0.4 mm. The length of the outer tube 54 is preferably 300 to 800 mm.

The tip tip 20 and the first tube portion 46 are joined by a joint portion 30. As shown in FIG. 2, the joint portion 30 is connected to the tip tip proximal end 20a, which is the proximal end of the tip tip 20. For example, the joint portion 30 is formed by curing the adhesive that joins the proximal end 20a of the tip tip and the outer periphery of the first tube portion 46 exposed from the proximal end 20a of the tip tip. The joint portion 30 can be formed of an adhesive cured portion obtained by curing an adhesive such as a cyanoacrylate adhesive or an epoxy adhesive, but the material of the joint portion 30 is not particularly limited. When the joint portion 30 is formed with an adhesive, an adhesive is applied to the outer periphery of the distal end portion of the first tube portion 46, and the adhesive is applied to the distal end of the first tube portion 46. The end portion may be inserted into the blood flow hole 20c of the tip tip 20 to cure the adhesive. At this time, a sufficient amount of adhesive may be applied to the outer periphery of the distal end portion of the first tube portion 46 so as not to cause poor adhesion between the first tube portion 46 and the tip tip 20. Desirably, specifically, after the adhesive is cured, the adhesive cured portion exposed from the tip tip 20 is formed on the proximal end side of the proximal end 20a of the tip tip as in the present embodiment shown in FIG. It is desirable to apply an amount of adhesive that causes the joint portion 30 to form.

The distal end of the balloon 60 is fixed to the outer circumference of the tip tip 20, and the proximal end of the balloon 60 is fixed to the outer circumference 48d of the second tube portion 48. The method of fixing the balloon 60 to the tip tip 20 and the second tube portion 48 is not particularly limited, but is performed by heat fusion or adhesion. The balloon 60 includes a part of the tip 20 on the proximal end side, a joint portion 30, a first exposed portion 46c of the first tube portion 46 exposed from the tip tip 20 and the joint portion 30, and a second. A part of the tube portion 48 on the distal end side is housed inside.

The space inside the balloon 60 is connected to the second lumen 40d of the second tube portion 48. In driving the balloon 60 in the IABP method, a pressure fluid is introduced and derived into the space inside the balloon 60 via the second lumen 40d. This allows the balloon 60 to expand and contract in response to the beating of the heart.

The balloon 60 is composed of a thin film having a film thickness of about 30 to 150 μm. The material of the thin film is not particularly limited, but is preferably a material having excellent bending fatigue resistance, and is made of, for example, polyurethane. The outer diameter and length of the balloon 60 are determined according to the inner volume of the balloon 60, which greatly affects the auxiliary effect of cardiac function, the inner diameter of the arterial blood vessel, and the like. The internal volume of the balloon 60 is not particularly limited, but is 20 to 50 cc, and the outer diameter of the balloon 60 is preferably 12 to 19 mm when inflated, and the length is preferably 150 to 260 mm. The method for manufacturing the balloon 60 is not particularly limited, but the balloon 60 is manufactured by blow molding, dip molding, or the like. The details of the shape of the balloon 60 will be described later with reference to FIG.

As shown in FIG. 1, the branch portion 70 to which the proximal end of the catheter tube is connected has a straight portion 72 extending along the axial direction of the balloon catheter 10 and a straight portion 72 inclined with respect to the axial direction. It has an inclined portion 76 connected to the branch position 70c. The straight portion 72 is provided with an inner pipe fixing portion 73 for fixing the proximal end of the inner pipe 52 and an outer pipe fixing portion 75 for fixing the proximal end of the outer pipe 54.

In the straight portion 72, the inner pipe fixing portion 73 is provided on the proximal end side of the branch position 70c. A blood pressure measuring port 74 communicating with the first lumen 40c of the inner tube 52 is formed near the straight portion 72.

The outer tube fixing portion 75 is provided on the distal end side from the branch position 70c. The inclined portion 76 is formed with a pressure fluid conducting path 77 communicating with the second lumen 40d inside the outer pipe 54, and the proximal end of the inclined portion 76 is an entrance to the pressure fluid conducting path 77. A pressure fluid inlet / outlet 78 is formed.

The pressure fluid inlet / outlet 78 is connected to a pump device (not shown), which allows the pressure fluid to be introduced and derived into the balloon 60 via the second lumen 40d of the outer pipe 54. .. The pressure fluid is not particularly limited, but helium gas having a small viscosity and a small mass is used so that the balloon 60 expands and contracts quickly in response to the drive of the pump device.

The blood pressure measuring port 74 is connected to a blood pressure measuring device (not shown), and can measure fluctuations in blood pressure in an artery taken in from a blood flow hole 20c of a tip tip 20 via a first lumen 40c. Based on the fluctuation of blood pressure measured by this blood pressure measuring device, the pump device is controlled according to the heartbeat, and the balloon 60 is inflated and contracted in a short cycle of 0.4 to 1 second. The first lumen 40c and the blood flow hole 20c are also used as a lumen through which a guide wire that guides the distal end of the balloon catheter 10 is inserted when the balloon 60 is inserted to the descending aorta of the chest.

FIG. 2 is a schematic side view showing the shape of the distal end portion of the balloon catheter 10 in an inflated state. In FIG. 2, the members inside the balloon 60 are also shown by solid lines except for the members inside the other members.

The balloon 60 is a tubular first neck portion 62 having a predetermined outer diameter and a part of the distal end side fixed to the outer circumference 20d of the tip tip 20, and a proximal end of the first neck portion 62. A first cone portion 64 that is connected to the proximal end 62a of the first neck portion and whose outer diameter expands toward the proximal end side, and a straight body portion 66 that is connected to the proximal end of the first cone portion 64. Have.

The first neck portion 62 has a substantially constant outer diameter along the axial direction and has a straight cylinder shape. The angle θ1 formed by the outer peripheral surface of the first neck portion 62 in the axial direction is at least smaller than the angle θ2 formed by the outer peripheral surface of the first cone portion 64 in the axial direction, and is preferably 0 to 5 degrees. The first neck portion 62 extends toward the proximal end side from the tip tip 20, and in the axial positional relationship, the first neck portion proximal end 62a is the proximal end of the joint portion 30, which is the proximal end of the joint portion 30. It is located on the proximal end side of the end 30a. In other words, inside the proximal end 62a of the first neck portion, the first exposed portion 46c of the first tube portion 46 exposed from the tip 20 and the joint portion 30 is arranged.

The length L1 from the proximal end 20a of the tip tip to the proximal end 30a of the joint portion is not particularly limited, but the outer diameter bulges due to the joint portion 30 while securely fixing the tip tip 20 and the first tube portion 46. From the viewpoint of preventing the above, it is preferably 1 to 2 mm. The length L2 from the tip tip proximal end 20a to the first neck proximal end 62a is not particularly limited, but the central portion of the balloon 60 while avoiding overlap between the first cone portion 64 and the joint portion 30. It is preferably 4 to 7 mm so that the more distal end side portion does not become too long.

The angle formed by the outer peripheral surface of the balloon 60 in the axial direction changes at the proximal end 62a of the first neck portion. The angle θ2 formed by the outer peripheral surface of the first cone portion 64 in the axial direction is preferably 20 to 40 degrees. Further, the straight body portion 66 has a straight body tube shape with a substantially constant outer diameter along the axial direction like the first neck part 62. The balloon 60 is connected to a second cone portion which is connected to the proximal end of the straight body portion 66 and whose diameter decreases toward the proximal end side, and a second cone portion which is connected to the proximal end of the second cone portion. It further has a second neck portion fixed to the outer periphery of the two-tube portion 48. However, since the second cone portion and the second neck portion have a shape symmetrical with the first neck portion 62 and the first cone portion 64 shown in FIG. 2, the description thereof will be omitted.

FIG. 3 is a schematic view showing the shape of the distal end portion of the balloon catheter 10 in a state where the balloon 60 is wound. As shown in FIG. 3, the balloon catheter 10 is inserted from outside the body to the descending thoracic aorta using a sheath introducer or the like, if necessary, with the balloon 60 wrapped around the first tube portion 46.

In the balloon catheter 10, since the first neck portion 62 is located on the outer circumference of the joint portion 30, there is a problem that a bulge is formed around the joint portion 30 in a state where the balloon 60 is wound as shown in FIG. Can be prevented. This is because the outer diameter of the first neck portion 62 hardly changes from the portion fixed to the tip tip 20, and wrinkles and the like are unlikely to be formed in this portion even when the balloon 60 is wound around the first neck portion 62.

Further, regarding the first cone portion 64 whose diameter increases toward the proximal end side, a wrinkle 60d is formed in a state where the balloon 60 is wound, but the inside of the first cone portion 64 is outside the joint portion 30. Since the first exposed portion 46c having a small diameter is located, it is possible to avoid the problem that the outer diameter becomes large in the portion of the first cone portion 64. Therefore, the balloon catheter 10 prevents the problem that a bulge having a large outer diameter is formed in the vicinity of the joint 30 in the state where the balloon 60 is wound, and such a bulge is caught in the artery and deteriorates the insertability. The problem can be suitably prevented. Therefore, the balloon catheter 10 exhibits good insertability.

The above-described embodiment is only one embodiment of the balloon catheter according to the present invention, and the present invention has many other embodiments. For example, the balloon catheter 10 described above uses a coaxial type catheter tube 40 including an inner tube 52 and an outer tube 54, but the catheter tube is not limited to this, and other catheters such as a biaxial type catheter are used. It may be a tube.

Hereinafter, the present invention will be described with reference to examples, but the examples do not limit the present invention.

Example 2 Four samples (No. 1 to No. 4) of the balloon catheter 10 having the shape shown in FIG. 2 are prepared, the balloon 60 is wound around the catheter tube 40 as shown in FIG. 3, and the proximal end 30a of the joint is formed. The minimum value of the outer diameter in the range of ± 2 mm in the axial direction was measured using a laser outer diameter measuring device (LS-5500, manufactured by KEYENCE CORPORATION). The material of the balloon 60 was polyurethane, and the average thickness of the film constituting the balloon 60 was 48.7 μm in the straight body portion and 73.9 μm in the cone portion.

The length of the first neck portion 62 shown in FIG. 2 was 12 mm, the length of the first cone portion 64 was 13.5 mm, and the length of the straight body portion 66 was 163 mm. Further, the outer diameter of the tip tip was 2.3 mm, the outer diameter of the straight body portion 66 of the balloon 60 was 16.6 mm, and the outer diameter of the first tube portion 46 (inner tube 52) was 1.07 mm. The length L1 from the tip tip proximal end 20a to the joint proximal end 30a is the target value of 1.5 mm, and the length L2 from the tip tip proximal end 20a to the first neck proximal end 62a is the target value. It was set to 5 mm. The results are shown in Table 1.

Reference Example Four samples (No. 1 to No. 4) of the balloon catheter 100 having the shape shown in FIG. 4 were prepared, and the balloon 160 was wound around the catheter tube in the same manner as in FIG. 3, in the vicinity of the proximal end 30a of the joint. The maximum value of the outer diameter was measured in the same manner as in Examples. The balloon catheter 100 has the same shape as the balloon catheter 10 except that the length of the first neck portion 162 shown in FIG. 4 is 7 mm. The length L22 from the tip tip proximal end 20a to the neck proximal end 162a was set to 0.5 mm as a target value. The results are shown in Table 1.

As shown in Table 1, all of the balloon catheters 10 according to the examples have a smaller outer diameter near the proximal end 30a of the joint than the balloon catheter 100 according to the reference example, and the difference is about 10% on average. It was. As a result, it was confirmed that the balloon catheter 10 in which the first neck portion 62 is lengthened so that the first cone portion 64 does not overlap the joint portion 30 can suppress the swelling due to the joint portion 30 or the first neck portion 62. ..

10 ... Balloon catheter 20 ... Tip tip 20a ... Tip tip proximal end 30 ... Joint 30a ... Joint proximal end 40 ... Catheter tube 40c ... First lumen 40d ... Second lumen 46 ... First tube part 46b ... First Tube part distal end 46c ... 1st exposed part 48 ... 2nd tube part 52 ... Inner tube 54 ... Outer tube 60 ... Balloon 62 ... 1st neck part 62a ... 1st neck part Proximal end 64 ... 1st cone part

Claims (1)

With a tubular tip and
A catheter tube having a first lumen and a second lumen separated from the first lumen, the first lumen being formed internally, the distal end being inserted into the tip, and an outer diameter of 0.5. A catheter tube having a first tube portion of ~ 2.0 mm and a second tube portion in which the first lumen and the second lumen are formed and connected to the proximal end of the first tube portion.
A joint portion that is connected to the proximal end of the tip and joins the tip and the first tube portion.
The joint portion and the portion of the first tube portion exposed from the tip tip and the joint portion are housed inside, and the outer periphery of the tip and the outer periphery of the second tube portion. is fixed to a balloon catheter having a balloon outer diameter Ru 12~19mm der when inflated,
The joint portion has an adhesive curing portion that joins the proximal end of the tip tip and the outer periphery of the first tube portion exposed from the proximal end of the tip tip.
The balloon is connected to a tubular neck portion fixed to the tip and having a predetermined outer diameter and a proximal end of the neck portion, which is a proximal end of the neck portion, and faces the proximal end side. It has a cone part that expands the outer diameter.
The proximal end of the neck portion is located on the proximal end side of the proximal end of the adhesive hardening portion exposed from the proximal end of the tip tip, which is the proximal end of the joint portion .
The outer diameter of the portion of the first tube portion housed inside the balloon that is exposed from the tip tip and the joint portion is smaller than the outer diameter of the adhesive curing portion of the IABP. For balloon catheter.

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