JP7351085B2 - Balloon catheter for IABP - Google Patents

Description

The present invention relates to a balloon catheter for IABP (Intra-Aortic Balloon Pumping) used in the IABP (Intra-Aortic Balloon Pumping) method.

The IABP method using a balloon catheter is known as a treatment method for the case of decreased cardiac function. In the IABP method, a balloon catheter is inserted into an artery from the femoral artery or brachial artery, and the balloon is left in the descending thoracic aorta and expands and contracts in time with the heart's beats to assist cardiac function. It will be done.

Generally, insertion of a balloon catheter in the IABP method is performed, for example, in a cardiac catheterization laboratory, which is a laboratory for safely performing cardiac catheterization tests. An X-ray fluoroscope is installed in the cardiac catheterization room, and the balloon catheter normally used for IABP is equipped with an X-ray contrast marker near its distal end (for example, (see Patent Document 1), when inserting a balloon catheter in a cardiac catheterization room, the balloon catheter is inserted while confirming the position of the distal end of the balloon catheter using an X-ray fluoroscopic image.

In an environment where X-ray fluoroscopy is possible, such as in a cardiac catheterization lab, the balloon catheter can be inserted while confirming the position of the distal end of the balloon catheter, and the balloon can be placed in the descending thoracic aorta. On the other hand, for example, when it becomes necessary to apply the IABP method during surgery, or when you want to reconfirm the position of the distal end of the balloon catheter during surgery on a patient to whom the IABP method has been applied, It may be desirable to confirm the position of the distal end of the balloon catheter in an environment where X-ray fluoroscopy is not possible, such as in an operating room where the device is not installed. In an environment where X-ray fluoroscopy is not possible, it is difficult to confirm the position of the distal end of the balloon catheter by X-ray fluoroscopy, so a method of confirming the position using ultrasound echo is adopted. Specifically, a method has been adopted in which a transesophageal ultrasound device or the like is used to observe the heart from the esophagus using ultrasound to obtain an ultrasound fluoroscopic image.

Japanese Patent Application Publication No. 9-239034

However, since the ultrasonic fluoroscopic image has poorer image clarity than the X-ray fluoroscopic image, there is a problem in that it is difficult to grasp the position of the distal end of the balloon catheter from the ultrasonic fluoroscopic image.

The present invention has been made in view of the above-mentioned problems, and an object of the present invention is to provide a balloon catheter for IABP that has a simple configuration and improves the ultrasonic visibility of the distal end of the balloon catheter.

In order to achieve the above object, the balloon catheter for IABP according to the present invention has a distal tip and a balloon on the distal end side, and a first tube forming a first lumen communicating with the distal tip; A balloon catheter for IABP having a catheter tube including a second tube forming a second lumen communicating with the inside of the balloon,
The present invention is characterized in that the surface of at least some of the members disposed on the distal end side is provided with a rough surface that can be confirmed on an ultrasound image obtained by an ultrasound examination device.
According to the balloon catheter for IABP according to the present invention, the rough surface provided on the surface of at least a part of the member disposed on the distal end side has a property of diffusing reflected waves of an ultrasound beam, and This is a part with improved visibility of sound waves. That is, since the rough surface provided on the surface of at least some of the members disposed on the distal end side is visualized as a state that can be confirmed on the ultrasound fluoroscopic image, the rough surface provided on the surface of at least some members disposed on the distal end side The position of the balloon can be accurately confirmed on the ultrasound fluoroscopic image, and the balloon can be appropriately placed in the descending thoracic aorta by observation using ultrasound.

In the balloon catheter for IABP according to the present invention, the rough surface may be provided on at least a portion of the surface of the distal tip.

In the balloon catheter for IABP according to the present invention, the rough surface may be provided on at least a portion of the surface of the first tube near the distal end.

In the balloon catheter for IABP according to the present invention, the rough surface may be provided on at least a portion of the surface near the distal end of the balloon.

In the balloon catheter for IABP according to the present invention, a ring-shaped member having the rough surface provided on its surface may be disposed on the distal end side.

In the balloon catheter for IABP according to the present invention, the ring-shaped member may be fitted externally or internally to the distal tip.

In the balloon catheter for IABP according to the present invention, the ring-shaped member may be fitted externally or internally into the first tube.

In the balloon catheter for IABP according to the present invention, the surface roughness of the rough surface may be set within a range of 0.5 to 5.0 μm in terms of arithmetic mean roughness (Ra).

FIG. 1 is a diagram schematically showing a state in which a balloon of an IABP balloon catheter according to an embodiment of the present invention is placed in a descending thoracic aorta. FIG. 2 is a sectional view showing an example of the configuration of the IABP balloon catheter according to the first embodiment of the present invention. FIG. 3 is a perspective view showing the configuration near the distal end of the IABP balloon catheter according to the first embodiment of the present invention. FIG. 4 is a sectional view showing an example of the configuration of a balloon catheter for IABP according to the second embodiment of the present invention. FIG. 5 is a perspective view showing the configuration near the distal end of the IABP balloon catheter according to the second embodiment of the present invention. FIG. 6 is a sectional view showing an example of the configuration of a balloon catheter for IABP according to the third embodiment of the present invention. FIG. 7 is a perspective view showing the configuration near the distal end of the IABP balloon catheter according to the third embodiment of the present invention. FIG. 8 is a sectional view showing an example of the configuration of a balloon catheter for IABP according to the fourth embodiment of the present invention. FIG. 9 is a perspective view showing the configuration near the distal end of the IABP balloon catheter according to the fourth embodiment of the present invention. FIG. 10 is a perspective view showing a first derivative example of the configuration near the distal end of the IABP balloon catheter according to the fourth embodiment of the present invention. FIG. 11 is a perspective view showing a second derivative example of the configuration near the distal end of the IABP balloon catheter according to the fourth embodiment of the present invention. FIG. 12 is a perspective view showing a third derivative of the configuration near the distal end of the IABP balloon catheter according to the fourth embodiment of the present invention.

Embodiments of the present invention will be described in detail below with reference to the drawings. In the IABP balloon catheter 10 according to the embodiment of the present invention described below, for example, as shown in FIG. By expanding and deflating the balloon 40, the function of the heart is assisted. FIG. 1 shows a state in which the balloon 40 of the IABP balloon catheter 10 inserted from the femoral artery is indwelled in the descending thoracic aorta. 40 is illustrated.

[First embodiment]
A first embodiment of the present invention will be described. FIG. 2 is a sectional view showing an example of the configuration of the IABP balloon catheter according to the first embodiment of the present invention.

As shown in FIG. 2, the IABP balloon catheter 10a has a distal tip 20a, a catheter tube 30, a balloon 40, and a branch part 50. Although a part of the catheter tube 30 is broken and not shown in FIG. 2, the catheter tube 30 is actually connected, and the IABP balloon catheter 10a has an elongated shape. In the following, the extending direction of the IABP balloon catheter 10a will be referred to as the axial direction, the distal tip 20a side of the IABP balloon catheter 10a will be referred to as the distal end side, and the branch portion 50 side of the IABP balloon catheter 10a will be referred to as the proximal end side. Give an explanation.

The distal tip 20a is a member located at the most distal end of the IABP balloon catheter 10a. The distal tip 20a has a cylindrical shape, and the distal end of the distal tip 20a is rounded to achieve good insertability within the artery and to avoid damaging the artery wall. It is formed in a tapered shape. A through hole 21 is formed in the axial direction inside the distal tip 20a, and an inner tube 31 is inserted into and fixed to the through hole 21. A distal end portion 42 of a balloon 40 is joined to the outer peripheral surface of the proximal end side of the distal tip 20a. As will be described in detail later, a rough surface 25a is provided on the outer peripheral surface of the distal tip 20a.

The material of the tip 20a is not particularly limited, and for example, resins such as polyurethane and polyamide, polymer materials such as elastomers, and metal materials such as stainless steel can be used. In order to provide contrast properties in X-ray fluoroscopic images, the material of the distal tip 20a may contain a contrast agent, or a metal may be embedded in the distal tip 20a.

The size of the tip 20a is not particularly limited; for example, the axial dimension of the tip 20a is 5 to 25 mm, the outer diameter is 1.6 to 3.4 mm, and the inner diameter is 0.1 to 1.5 mm. It is. Since the inner tube 31 is inserted into the through hole 21, the inner diameter of the proximal end of the through hole 21 is preferably equal to the outer diameter of the distal end of the inner tube 31.

The catheter tube 30 is composed of an inner tube (first tube) 31 and an outer tube (second tube) 32 that are tube-shaped and extend in the axial direction. FIG. 1 shows a balloon catheter with a double lumen structure as an example of a balloon catheter 10a for IABP.

The inner diameter of the outer tube 32 is larger than the outer diameter of the inner tube 31, and the inner tube 31 is inserted into the inner lumen of the outer tube 32. A part of the outer circumferential surface of the inner tube 31 is fixed to a part of the inner circumferential surface of the outer tube 32 in a part or all of the axial direction of the inner tube 31 . Further, in order to provide contrast properties in an X-ray fluoroscopic image, a metal X-ray fluoroscopic member may be provided near the distal end of the inner tube 31 or the outer tube 32, for example. This X-ray fluoroscopy member is sometimes called a contrast marker.

The distal end of the outer tube 32 terminates near the proximal end 43 of the balloon 40 and opens into the space inside the balloon 40, and the proximal end of the outer tube 32 is connected to the outer tube fixing part 51 of the branch part 50. It is joined. On the other hand, both ends of the inner tube 31 inserted into the lumen of the outer tube 32 protrude from the outer tube 32, and the distal end of the inner tube 31 passes through the space inside the balloon 40 into the through hole 20 of the distal tip 20a. The proximal end of the inner tube 31 is connected to the blood pressure measurement port 56 through the side branch 53 of the branch 50 .

A first lumen 31L is formed inside the inner tube 31, a second lumen 32L is formed inside the outer tube 32 and outside the inner tube 31, and the first lumen 31L and the second lumen 32L are mutually connected. is isolated.

The first lumen 31L communicates with the through hole 21 of the tip 20a at the distal end of the inner tube 31, and communicates with the blood pressure measurement port 56 of the branch 50 at the proximal end of the inner tube 31, as described below. is connected to. The first lumen 31L is used as a blood flow path for taking in blood for blood pressure measurement and as a passage through which a guide wire can be inserted.

The second lumen 32L communicates with the space inside the balloon 40 on the distal end side of the outer tube 32, and communicates with the fluid supply/discharge port 55 of the branch portion 50 as described later. The second lumen 32L is used as a supply/discharge path through which fluid can be supplied/discharged through the fluid supply/discharge port 55, and the balloon 40 can be expanded and contracted by supplying/discharging fluid through this supply/discharge route.

Here, a configuration in which both ends of the inner tube 31 protrude from the outer tube 32 is taken as an example, but for example, the inner tube 31 terminates at the same end surface as the distal end of the outer tube 32, and the inner tube 31 is separated from the outer tube 32. By connecting two tubular members, both ends of the inner tube 31 may be configured to protrude from the outer tube 32.

The material of the catheter tube 30 is not particularly limited, but is preferably flexible, such as resin materials such as polyurethane, polyvinyl chloride, polyethylene, polyamide, polyether ether ketone (PEEK), and nickel titanium alloy. Metal materials such as metals such as , stainless steel, etc. can be used. The materials of the inner tube 31 and the outer tube 32 may be the same or different. As an example, the inner tube 31 of the catheter tube 30 is made of a PEEK tube, the outer tube 32 is made of a polyamide tube, and the outer peripheral surface of the outer tube 32 is coated with polyurethane, which has excellent antithrombotic properties.

The size of the inner tube 31 is not particularly limited, and for example, the axial dimension of the inner tube 31 is 500 to 1100 mm, the inner diameter is 0.1 to 2.0 mm, and the wall thickness is 0.05 to 0.4 mm. It is. The size of the outer tube 32 is not particularly limited, and the inner diameter of the outer tube 32 is set larger than the outer diameter of the inner tube 31. For example, the axial dimension of the outer tube 32 is 300 to 800 mm, and the inner diameter is 1.0 mm. ~4.0mm, and the wall thickness is 0.05~0.4mm.

The balloon 40 is a cylindrical thin film that can be expanded and contracted by supplying and discharging fluid therein, and is disposed at the distal end of the IABP balloon catheter 10a. More specifically, the balloon 40 includes an expansion/contraction section 41 that can be expanded and contracted by supplying and discharging fluid, a distal end section 42 located on the distal end side of the expansion/contraction section 41, and an expansion/contraction section 41. It is constituted by a proximal end portion 43 located on the proximal end side of. The expansion/contraction portion 41 of the balloon 40 has, for example, a tapered shape whose outer diameter decreases toward the distal end 42 and the proximal end 43.

The distal end portion 42 of the balloon 40 is joined to the outer circumferential surface of the distal tip 20a on the proximal end side. Near the distal end 42 of the balloon 40, the space inside the balloon 40 is closed. On the other hand, the proximal end 43 of the balloon 40 is joined to the outer peripheral surface of the outer tube 32 on the distal end side. Near the proximal end 43 of the balloon 40, the space inside the balloon 40 communicates with the second lumen 32L through the opening at the distal end of the outer tube 32, and through the second lumen 32L and the fluid supply/discharge port 55. Fluid is supplied and discharged to the space inside the balloon 40, and the balloon 40 can be expanded and deflated according to the amount of fluid supplied and discharged. Note that the method of joining the distal end 42 and proximal end 43 of the balloon 40 to the distal tip 20a and the outer tube 32 is not particularly limited, and includes, for example, adhesion using an adhesive, heat fusion, welding using a solvent, Ultrasonic welding etc. are possible.

The IABP balloon catheter 10a is used with its distal end inserted into an artery from the femoral artery or brachial artery, and the balloon 40 is placed in the descending thoracic aorta. The balloon 40 is inserted into an artery while being wrapped around the inner tube 31, and is expanded and deflated by fluid after being placed in the descending thoracic aorta.

The material of the balloon 40 is not particularly limited, but it is preferably a material with excellent bending fatigue resistance, and for example, a resin material such as polyurethane can be used. The size of the balloon 40 is not particularly limited, and is determined depending on the internal volume of the balloon 40, which greatly affects the effect of assisting cardiac function, and the inner diameter of the arterial blood vessel. For example, the balloon 40 has an internal volume of 20 to 50 ml, a membrane thickness of 20 to 200 μm, an outer diameter (when expanded) of 10 to 25 mm, and an axial dimension of 110 to 300 mm.

The branch part 50 is a molded body having an inner cavity having openings at three locations: an outer tube insertion port 54, a fluid supply/discharge port 55, and a blood pressure measurement port 56. 53.

The outer tube fixing part 51 is a part on the distal end side of the branch part 50, and has an outer tube insertion port 54 on the distal end side. The proximal end of the outer tube 32 is inserted into the outer tube insertion port 54, and the outer tube 32 is fixed by the outer tube fixing part 51. The outer tube 32 opens into the inner cavity of the branch section 50 at the outer tube fixing section 51 .

The main body 52 is one of two parts branched from the outer tube insertion port 54 of the outer tube fixing part 51, and has a fluid supply/discharge port 55 on its proximal end side. The fluid supply/discharge port 55 communicates with the outer tube insertion port 54 through which the outer tube 32 is opened, that is, the fluid supply/discharge port 55 communicates with the second lumen 32L.

The fluid supply/discharge port 55 is connected to a pump device (not shown) and is capable of supplying fluid to the space inside the balloon 40 through the second lumen 32L and discharging the fluid from the space. With the balloon 40 indwelled in the descending thoracic aorta, the balloon 40 is expanded and deflated in accordance with the heartbeat while controlling the amount and timing of fluid supply and discharge to assist cardiac function. becomes possible. Although the fluid used to expand and deflate the balloon 40 is not particularly limited, for example, helium gas, which is an inert gas with low viscosity and mass, is used in consideration of responsiveness to drive of the pump device, safety, etc. It will be done.

The side branch portion 53 is the other portion branched into two from the opening of the outer tube fixing portion 51, and has a blood pressure measurement port 56 at its proximal end side. The blood pressure measurement port 56 is connected to the inner tube 31, that is, the blood pressure measurement port 56 communicates with the first lumen 31L.

The blood pressure measurement port 56 is connected to a blood pressure measurement device (not shown), and can measure blood pressure fluctuations in the artery through the through hole 21 of the distal tip 20a and the first lumen 31L. By controlling the pump device based on changes in blood pressure measured by this blood pressure measuring device, it becomes possible to expand and deflate the balloon 40 in accordance with the heart beat.

The blood pressure measurement port 56 also functions as a guide wire insertion port used when inserting the IABP balloon catheter 10a. When the balloon 40 is placed in the descending thoracic aorta, the distal end of the IABP balloon catheter 10a, through which the guide wire is inserted from the blood pressure measurement port 56 through the first lumen 31L and toward the through hole 21 of the distal tip 20a, is inserted into the thigh. The balloon 40 can be guided and placed in the descending thoracic aorta by inserting it from an artery or brachial artery and pushing the distal end of the IABP balloon catheter 10a along the guide wire while leading the guide wire. The guide wire used has an outer diameter smaller than the inner diameter of the inner tube 31 and can be inserted into the inner tube 31.

The material of the branch part 50 is not particularly limited, and for example, thermoplastic resin materials such as ABS (acrylonitrile butadiene styrene copolymer), polystyrene, polypropylene, polycarbonate, etc. can be used, and the branch part 50 is formed using a mold. May be molded. The size (axial dimension) of the branch portion 50 is not particularly limited, and is, for example, 10 to 150 mm.

FIG. 3 is a perspective view schematically showing the configuration near the distal end of the IABP balloon catheter 10a according to the first embodiment of the present invention. FIG. 3 is a perspective view of the IABP balloon catheter 10a of FIG. 2, viewed obliquely from above on the distal end side. In FIG. 3, the distal tip 20a and the inner tube 31 are illustrated halfway, the distal tip 20a being drawn with a solid line, and the inner tube 31 including the portion inserted into the distal tip 20a being drawn with a dotted line. . Further, the balloon 40 is not shown in FIG. 3.

As shown in FIGS. 2 and 3, the outer peripheral surface of the distal tip 20a is provided with a rough surface 25a by forming fine irregularities. The fine irregularities constituting the rough surface 25a provided on the tip 20a can be formed by processing the tip 20a after manufacturing the tip 20a using a mold, for example. , for example, by using a barrel polishing method. The barrel polishing method involves placing the workpiece and abrasive material in a barrel container, adding compound, water, etc. as necessary, and applying rotational motion or vibration to the barrel container to polish the surface of the workpiece. This is a processing method that forms fine irregularities on the surface.

The method for forming the fine irregularities constituting the rough surface 25a is not limited to the barrel polishing method described above, and a blasting method may be employed. Blasting is a process in which small grains such as sand (e.g., granular abrasives made of iron, glass, alumina, etc.) are struck against the workpiece using pressure such as compressed air, creating fine particles on the surface of the workpiece. This is a processing method that creates unevenness. The fine irregularities constituting the rough surface 25a may be formed by a chemical surface treatment method such as etching, or may be formed by irregularly scraping the surface using sandpaper, a metal brush, etc. . In addition, when the distal tip 20a is made of a polymeric material, the fine irregularities constituting the rough surface 25a of the distal tip 20a are formed on the inner surface of the mold for manufacturing the distal tip 20a as described above. The tip tip 20a is formed by forming fine irregularities by a processing method and then molding the tip tip 20a using the mold, thereby transferring the fine irregularities provided on the inner surface of the mold to the tip tip 20a. Good too.

The surface roughness of the rough surface 25a provided on the distal tip 20a is preferably a roughness that can improve visibility on ultrasound images, for example, an arithmetic mean roughness (Ra) of 0.5 to 5. It can be set within a range of 0 μm.

The rough surface 25a may be provided on part or all of the surface of the distal tip 20a, including the outer circumferential surface or the inner circumferential surface. As an example, FIGS. 2 and 3 show a distal tip 20a in which a rough surface 25a is provided on the entire outer circumferential surface, but the rough surface 25a is provided only on a part of the outer circumferential surface of the distal tip 20a. Alternatively, it may be provided on a part or all of the inner circumferential surface of the distal tip 20a, that is, the inner circumferential surface of the through hole 21. Furthermore, the rough surface 25a may be set to any shape and size.

Next, the effects when using the IABP balloon catheter 10a according to the first embodiment of the present invention will be described.

In the IABP method, the IABP balloon catheter 10a is inserted into the artery from the femoral artery or brachial artery, and the balloon 40 provided at the distal end of the IABP balloon catheter 10a is placed in the descending thoracic aorta.

In an environment where an X-ray fluoroscope is installed and where X-ray fluoroscopy is possible, the distal tip 20a provided with contrast properties for X-ray fluoroscopy and the contrast marker provided near the distal end of the IABP balloon catheter 10a are used. Since this can be confirmed on the X-ray fluoroscopic image, the balloon 40 can be placed in the descending thoracic aorta while confirming the position of the balloon 40.

On the other hand, in environments such as operating rooms where X-ray fluoroscopic equipment is not installed and X-ray fluoroscopy is not possible, the IABP balloon may be When placing the balloon 40 of the catheter 10a in the descending thoracic aorta or confirming the position of the balloon 40 that has been placed in the descending thoracic aorta before surgery, the position of the balloon 40 can be confirmed by ultrasound fluoroscopy. . At this time, for example, a method is employed in which a transesophageal ultrasound examination device is used to observe the heart using ultrasound from the esophagus to obtain an ultrasound fluoroscopic image.

An ultrasound fluoroscopic image is an image of echo waves detected by applying an ultrasound beam to an object. However, due to the relationship between the acoustic characteristics of the tissue in the living body and the IABP balloon catheter 10a, the state of the distal end side of the IABP balloon catheter 10a may not be sufficiently confirmed in the ultrasound fluoroscopic image.

In contrast, in the first embodiment of the present invention, a rough surface 25a is provided on part or all of the surface of the distal tip 20a, which is a member disposed on the distal end side of the IABP balloon catheter 10a. ing. This rough surface 25a has ultrasound visibility, and is visualized as a state that can be confirmed on an ultrasound fluoroscopic image due to the acoustic characteristics of ultrasound. As a result, the position near the distal end of the IABP balloon catheter 10a, that is, the position of the tip 20a, can be accurately confirmed on the ultrasound fluoroscopic image, and the balloon 40 can be appropriately placed in the descending thoracic aorta. becomes possible.

As explained above, in the IABP balloon catheter 10a according to the first embodiment of the present invention, the rough surface 25a is provided on part or all of the surface of the distal tip 20a, and the ultrasonic visual recognition of the distal tip 20a is performed. can improve sex. This makes it possible to accurately confirm the position of the distal tip 20a located near the distal end of the IABP balloon catheter 10a on the ultrasonic fluoroscopic image, even in environments where X-ray fluoroscopy is not possible. Even when the balloon 40 is placed in the descending thoracic aorta, the balloon 40 can be properly placed in the descending thoracic aorta.

[Second embodiment]
A second embodiment of the present invention will be described. FIG. 4 is a sectional view showing an example of the configuration of a balloon catheter for IABP according to the second embodiment of the present invention. Hereinafter, regarding the IABP balloon catheter 10b according to the second embodiment of the present invention, only the members different from those in the first embodiment of the present invention will be explained, and the explanation of the common members will be omitted.

In the first embodiment of the present invention described above, a rough surface 25a is provided on the distal tip 20a of the members disposed on the distal end side of the IABP balloon catheter 10a. On the other hand, as shown in FIG. 4, in the second embodiment of the present invention, the distal tip 20 is not provided with a rough surface, and is one of the members disposed on the distal end side of the IABP balloon catheter 10b. A rough surface 35b is provided near the distal end of the inner tube 31b.

FIG. 5 is a perspective view schematically showing the configuration near the distal end of the IABP balloon catheter 10b according to the second embodiment of the present invention. FIG. 5 is a perspective view of the IABP balloon catheter 10b of FIG. 4, viewed diagonally from above on the distal end side. In FIG. 5, the distal tip 20 and the inner tube 31b are illustrated halfway, with the distal tip 20 being drawn with a dotted line and the inner tube 31b being drawn with a solid line. Further, the balloon 40 is not shown in FIG. 5.

As shown in FIGS. 4 and 5, the outer peripheral surface of the inner tube 31b of the catheter tube 30b near the distal end side is provided with a rough surface 35b by forming fine irregularities. As an example, in the inner tube 31b shown in FIG. 4 and FIG. A rough surface 35b is provided on the entire outer peripheral surface of the tube 31b.

The fine irregularities constituting the rough surface 35b provided on the inner tube 31b can be formed by barrel polishing or blasting, similar to the case where the rough surface 25a is provided on the distal tip 20a in the first embodiment of the present invention. , a chemical surface treatment method, etc., or by irregularly scraping the surface using sandpaper, a metal brush, etc.

The surface roughness of the rough surface 35b provided on the inner tube 31b is preferably a roughness that can improve visibility on ultrasonic images, for example, an arithmetic mean roughness (Ra) of 0.5 to 5. It can be set within a range of 0 μm.

The rough surface 35b may be provided on a surface including the outer circumferential surface or inner circumferential surface near the distal end of the inner tube 31b. 4 and 5, as an example, an inner tube 31b is shown in which a rough surface 35b is provided on the entire outer circumferential surface within a predetermined dimension L1 from the most distal end. It may be provided on the inner circumferential surface of the tube 31b, that is, on a part of the lumen surface of the inner tube 31b.

The rough surface 35b may be set to any shape and any size; for example, the predetermined dimension L1 in FIGS. 4 and 5 may be set to any dimension. As a preferred example, if the axial dimension of the inner tube 31b inserted into the through hole 21 of the distal tip 20 is approximately 5 mm, the predetermined dimension L1 may be set to approximately 15 mm. In this case, the rough surface 35b is exposed within a range of about 10 mm in the axial direction from the proximal end of the distal tip 20.

The predetermined dimension L1 may be set according to the length of the balloon 40. For example, if the length of the balloon 40 is approximately 210 mm, the predetermined dimension L1 may also be set to the same approximately 210 mm. . In this case, the rough surface 35b is provided over the entire portion of the inner tube 31b included in the space inside the balloon 40.

The predetermined dimension L1 may be set smaller than the axial dimension of the inner tube 31b inserted into the through hole 21 of the distal tip 20. For example, the rough surface 35b may be provided only on the outer circumferential surface or inner circumferential surface of the inner tube 31b in the portion inserted into the through hole 21 of the distal tip 20.

Here, a case is described in which the rough surface 35b is provided in a range of a predetermined dimension L1 from the most distal end of the inner tube 31b, but the rough surface 35b is provided at a position away from the most distal end of the inner tube 31b. A range may be set.

Even when the balloon catheter 10b for IABP in the second embodiment of the present invention is used, the same effects as in the first embodiment of the present invention described above can be obtained. That is, even in an environment where it is impossible to perform X-ray fluoroscopy, the position near the distal end of the IABP balloon catheter 10b, that is, the position near the distal end of the inner tube 31b, can be detected using an ultrasonic fluoroscope. It becomes possible to accurately confirm the balloon 40 on the ultrasound fluoroscopic image obtained using the fluoroscopic ultrasound image, and it becomes possible to appropriately indwell the balloon 40 in the descending thoracic aorta.

As explained above, in the IABP balloon catheter 10b according to the second embodiment of the present invention, the rough surface 35b is formed on part or all of the surface of the inner tube 31b near the distal end side of the IABP balloon catheter 10b. The ultrasonic visibility of the inner tube 31b near the distal end can be improved. This makes it possible to accurately confirm the position of the inner tube 31b placed near the distal end of the IABP balloon catheter 10b on the ultrasonic fluoroscopic image, even in environments where X-ray fluoroscopy is not possible. Even when the balloon 40 is placed in the descending thoracic aorta, the balloon 40 can be properly placed in the descending thoracic aorta.

[Third embodiment]
A third embodiment of the present invention will be described. FIG. 6 is a sectional view showing an example of the configuration of a balloon catheter for IABP according to the third embodiment of the present invention. Hereinafter, regarding the IABP balloon catheter 10c according to the third embodiment of the present invention, only the different members from the first embodiment of the present invention will be explained, and the explanation of the common members will be omitted.

In the first embodiment of the present invention described above, the distal tip 20a of the members disposed on the distal end side of the IABP balloon catheter 10a is provided with the rough surface 25a. In the third embodiment, the distal tip 20 is not provided with a rough surface, and a rough surface 45c is provided near the distal end side of the balloon 40c among the members arranged on the distal end side of the IABP balloon catheter 10c. is provided.

FIG. 7 is a perspective view schematically showing the vicinity of the distal end of an IABP balloon catheter 10c according to the third embodiment of the present invention. FIG. 7 is a perspective view of the IABP balloon catheter 10c of FIG. 6, viewed obliquely from above on the distal end side. In FIG. 7, the distal tip 20, the inner tube 31, and the balloon 40c are illustrated halfway, the distal tip 20 and the inner tube 31 are drawn with dotted lines, and the expansion/contraction portion 41c and the distal end 42c of the balloon 40c are illustrated with solid lines. It is depicted in

As shown in FIGS. 6 and 7, the outer surface of the balloon 40c is provided with a rough surface 45c by forming fine irregularities. As an example, in FIGS. 6 and 7, a rough surface 45c is provided on a portion of the outer surface of the distal end portion 42c of the balloon 40c and the expansion/contraction portion 41c.

The fine irregularities constituting the rough surface 45c provided on the balloon 40c can be formed by barrel polishing, blasting, etc., similar to the case where the rough surface 25a is provided on the distal tip 20a in the first embodiment of the present invention. It may be formed by a chemical surface treatment method or the like, or by irregularly scraping the surface using sandpaper, a metal brush, or the like. However, the balloon 40c is a thin film, and it is preferable to provide a rough surface 45c to prevent the balloon 40c from being torn or punctured.

The surface roughness of the rough surface 45c provided on the balloon 40c is preferably a roughness that can improve visibility on ultrasound images, for example, an arithmetic mean roughness (Ra) of 0.5 to 5.0 μm. It can be set within the range of . As mentioned above, the film thickness of the balloon 40c is 30 to 150 μm, and it is possible to provide the rough surface 45c with an arithmetic mean roughness (Ra) in the range of 0.5 to 5.0 μm. The thickness of the portion of the balloon 40c where the rough surface 45c is provided may be made thicker so that the strength of the balloon 40c can be ensured even when the rough surface 45c is provided.

The rough surface 45c may be set to any shape and size. In FIGS. 6 and 7, a rough surface 45c is provided on a part of the distal end side of the distal end 42c of the balloon 40c and the expansion/contraction section 41c. It may be provided on either one of the parts. For example, the rough surface 45c may be provided only on the distal end portion 42c while maintaining the strength of the expansion and contraction portion 41c without providing the rough surface 45c on the expansion and contraction portion 41c. Furthermore, the rough surface 45c may be provided on the outer surface of the balloon 40c that faces outward when the balloon 40c is expanded, or may be provided on the inner surface of the balloon 40c that faces inward when the balloon 40c is expanded. .

Even when the IABP balloon catheter 10c according to the third embodiment of the present invention is used, the same effects as those of the first embodiment of the present invention described above can be obtained. That is, even in an environment where it is impossible to perform X-ray fluoroscopy, it is possible to determine the position near the distal end of the IABP balloon catheter 10c, that is, the position near the distal end of the balloon 40c of the IABP balloon catheter 10c. This can be accurately confirmed on the ultrasound fluoroscopic image obtained using the ultrasound fluoroscope, and the balloon 40c can be appropriately placed in the descending thoracic aorta.

As explained above, in the IABP balloon catheter 10c according to the third embodiment of the present invention, the balloon 40c of the IABP balloon catheter 10c is provided with a rough surface 45c, and the balloon 40c near the distal end thereof is provided with a rough surface 45c. Ultrasonic visibility can be improved. This makes it possible to accurately confirm the position of the balloon 40c placed near the distal end of the IABP balloon catheter 10c on the ultrasonic fluoroscopic image, even under an environment where X-ray fluoroscopy is not possible. Also, the balloon 40c can be appropriately placed in the descending thoracic aorta.

[Fourth embodiment]
A fourth embodiment of the present invention will be described. FIG. 8 is a sectional view showing an example of the configuration of a balloon catheter for IABP according to the fourth embodiment of the present invention. Hereinafter, regarding the IABP balloon catheter 10d in the fourth embodiment of the present invention, only the members different from those in the first embodiment of the present invention will be explained, and the explanation of the common members will be omitted.

In the first embodiment of the present invention described above, the distal tip 20a of the members disposed near the distal end side of the IABP balloon catheter 10a is provided with the rough surface 25a. In the fourth embodiment, the distal tip 20 is not provided with a rough surface, and a ring-shaped member 60d provided with a rough surface 65d on the distal end side of the IABP balloon catheter 10d is fitted onto the inner tube 31. and fixed.

FIG. 9 is a plan view schematically showing the vicinity of the distal end of the IABP balloon catheter 10d according to the fourth embodiment of the present invention. FIG. 9 is a perspective view of the IABP balloon catheter 10d of FIG. 8 when viewed obliquely from above on the distal end side. In FIG. 9, the distal tip 20 and the inner tube 31 are illustrated halfway, the distal tip 20 and the inner tube 31 are drawn with a solid line, and the ring-shaped member 60d is illustrated with a solid line. In addition, the balloon 40 is not shown in FIG. 9 .

As shown in FIGS. 8 and 9, a ring-shaped member 60d is fitted onto and fixed to the inner tube 31, and a rough surface 65d is formed on the outer peripheral surface of the ring-shaped member 60d by forming fine irregularities. It is provided.

The fine irregularities constituting the rough surface 65d provided on the ring-shaped member 60d are formed by barrel polishing or blasting, similar to the case where the rough surface 25a is provided on the distal tip 20a in the first embodiment of the present invention. It may be formed by a chemical surface treatment method, etc., or by irregularly scraping the surface using sandpaper, a metal brush, etc.

The surface roughness of the rough surface 65d provided on the ring-shaped member 60d is preferably a roughness that can improve visibility on ultrasonic images, for example, an arithmetic mean roughness (Ra) of 0.5 to 5. It can be set within a range of .0 μm.

The ring-shaped member 60d may be set to any shape and any size, and the rough surface 65d may be set to any shape and any size. In FIGS. 8 and 9, the rough surface 65d is provided on the entire outer circumferential surface of the ring-shaped member 60d, but it may be provided on a part of the outer circumferential surface of the ring-shaped member 60d. Furthermore, the rough surface 65d may be provided on a part or all of the inner peripheral surface of the ring-shaped member 60d.

Furthermore, the position where the ring-shaped member 60d is provided can also be set arbitrarily. 8 and 9, a ring-shaped member 60d provided with a rough surface 65d is fitted onto and fixed to the inner tube 31, but the ring-shaped member 60d provided with a rough surface 65d is As shown in the derivative example, it may be fitted onto and fixed to the distal tip 20. At this time, the ring-shaped member 60d fitted onto the distal tip 20 may be disposed on the distal end side of the distal end portion 42 of the balloon 40 joined to the distal tip 20, It may be arranged so as to cover the distal end portion 42.

The ring-shaped member 60d provided with the rough surface 65d may be fitted and fixed in the through hole 21 of the distal tip 20 as shown in the second derivative example of FIG. 11, or as shown in the third derivative example of FIG. 12. It may be internally fitted and fixed in the lumen of the inner tube 31 as shown in FIG. When the ring-shaped member 60d is fitted into the through-hole 21 of the distal tip 20 or the inner cavity of the inner tube 31, the guide wire is inserted through the ring-shaped member 60d. is set larger than the outer diameter of the

Even when the IABP balloon catheter 10d according to the fourth embodiment of the present invention is used, the same effects as those of the first embodiment of the present invention described above can be obtained. That is, even in an environment where it is impossible to perform X-ray fluoroscopy, the ring placed near the distal end of the IABP balloon catheter 10d, that is, the ring placed near the distal end of the IABP balloon catheter 10d. The position of the shaped member 60d can be accurately confirmed on the ultrasound fluoroscopic image obtained using the ultrasound fluoroscope, and the balloon 40 can be appropriately placed in the descending thoracic aorta.

As explained above, in the IABP balloon catheter 10d according to the fourth embodiment of the present invention, the ring-shaped member 60d disposed near the distal end of the IABP balloon catheter 10d is provided with a rough surface 65d. Therefore, the ultrasonic visibility of the ring-shaped member 60d disposed near the distal end can be improved. This makes it possible to accurately confirm the position of the ring-shaped member 60d placed near the distal end of the IABP balloon catheter 10d on the ultrasound fluoroscopic image, even in environments where X-ray fluoroscopy is not possible. Even if the balloon 40 is placed in the descending thoracic aorta, the balloon 40 can be properly placed in the descending thoracic aorta.

The embodiment described above is only an example of the IABP balloon catheter according to the present invention, and various modifications may be made. For example, in the above description, the first to fourth embodiments have been described individually, but it is possible to arbitrarily combine two or more of the embodiments.

Further, the embodiments described above are described to facilitate understanding of the present invention, and are not described to limit the present invention. Therefore, each element disclosed in the embodiments described above is intended to include all design changes and equivalents that fall within the technical scope of the present invention.

10, 10a, 10b, 10c, 10d Balloon catheter for IABP 20, 20a Distal tip 21 Through hole 25a, 35b, 45c, 65d Rough surface 30, 30b Catheter tube 31, 31b Inner tube (first tube)
31L 1st lumen 32 Outer tube (second tube)
32L Second lumen 40, 40c Balloon 41, 41c Expansion/contraction part 42, 42c Distal end part 43 Proximal end part 50 Branch part 51 Outer tube fixing part 52 Main body 53 Side branch part 54 Outer tube insertion port 55 Fluid supply/discharge port 56 Blood pressure measurement port 60d Ring-shaped member

Claims (1)

A first tube having a distal tip and a balloon on the distal end side and forming a first lumen communicating with the distal tip, and a second tube forming a second lumen communicating with the inside of the balloon. A balloon catheter for IABP having a catheter tube comprising:
At least a part of the surface of the distal tip is provided with a rough surface that can be confirmed on an ultrasound image obtained by an ultrasound inspection device,
The rough surface is composed of irregularly arranged fine irregularities,
A balloon catheter for IABP, wherein the surface roughness of the rough surface is set within a range of 0.5 to 5.0 μm in terms of arithmetic mean roughness (Ra).

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