JP7606053B2 - Balloon catheter - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is based on Japanese Application No. 2022-111430, filed on July 11, 2022, the contents of which are incorporated herein by reference.

The present disclosure relates to a balloon catheter.

Balloon catheters have traditionally been used in treatments such as PTA (percutaneous transluminal angioplasty) and PTCA (percutaneous transluminal coronary angioplasty). A balloon catheter has an inflatable and deflated balloon at its distal end. With a balloon catheter, the balloon is introduced in a deflated state to a site that has been narrowed or blocked by a lesion or the like that has occurred in a blood vessel, and then the balloon is inflated to expand the site.

Some balloon catheters are provided with linear elements extending in the axial direction on the outer surface of the balloon. The elements are provided in a state where they protrude from the outer surface of the balloon. In balloon catheters with elements, the balloon is inflated to press the elements against the lesion, thereby treating the lesion. For example, Patent Document 1 discloses a Scoliang balloon catheter as a balloon catheter with elements, which is capable of making an incision in the lesion by having the element bite into the lesion. With this balloon catheter, it is possible to facilitate the expansion of the lesion by using the incision made in the lesion as a trigger.

Patent No. 5600745

However, in the balloon catheter with the above-mentioned elements, the outer diameter of the balloon is increased by the amount of the elements provided on the outer surface of the balloon. This raises concerns about a decrease in ease of insertion when inserting the balloon into the body.

The present disclosure has been made in consideration of the above circumstances, and has as its primary objective the suppression of a decrease in insertability in a balloon catheter having linear protrusions on the outer surface of the balloon.

In order to solve the above problem, the balloon catheter of the first disclosure is a balloon catheter comprising an inflatable and deflatable balloon and a protruding portion that protrudes from the outer surface of the balloon and extends linearly along the outer surface, the protruding portion extending in the longitudinal direction of the protruding portion and having a pair of opposing upstanding portions that rise from the outer surface, the protruding portion being formed by connecting the upstanding portions to each other, and the upstanding portions being arranged so as to be tiltable relative to the outer surface.

According to the first disclosure, a linear protrusion is provided on the outer surface of the balloon. The protrusion has a pair of standing parts that extend in the longitudinal direction of the protrusion and stand up from the outer surface of the balloon. These standing parts face each other, and the protrusion is formed by connecting the standing parts to each other. In addition, each standing part is provided so as to be tiltable with respect to the outer surface of the balloon. In this case, the protrusion as a whole can be brought into a tilted state by tilting each standing part. Therefore, in a configuration in which a protrusion is provided on the outer surface of the balloon, it is possible to suppress an increase in the outer diameter of the balloon. This makes it possible to suppress a decrease in the insertability when inserting the balloon into the body.

In the second disclosure, the balloon catheter of the first disclosure has a protruding portion extending in the axial direction of the balloon, and the balloon is formed in its contracted state and has a wing portion that is folded circumferentially of the balloon and a wing opposing portion that faces the wing portion on the inner side of the wing portion, and when the balloon is in the contracted state, each of the upright portions is sandwiched between the wing portion and the wing opposing portion and is in the tilted state.

According to the second disclosure, when the balloon is in a deflated state, each standing portion is sandwiched between the wing portion and the wing opposing portion and is inclined. In this case, it is possible to prevent the outer diameter of the balloon from increasing when the balloon is in a deflated state. Therefore, it is possible to prevent a decrease in insertability when the balloon is inserted into the body in a deflated state.

In addition, because each standing portion is sandwiched between the wing portion and the wing opposing portion, it is easy to maintain the tilted state of each standing portion. This makes it possible to effectively prevent the outer diameter of the balloon from increasing when the balloon is in a deflated state, and as a result, it is possible to effectively prevent a decrease in insertability.

The balloon catheter of the third disclosure is the same as that of the second disclosure, in which one of the upright portions is fixed to the wing portion and the other is fixed to the wing opposing portion.

According to the third disclosure, one of the standing portions is fixed to the wing portion, and the other is fixed to the wing opposing portion. In this case, when each standing portion is sandwiched between the wing portion and the wing opposing portion, one standing portion is tilted relative to the outer surface of the wing portion, and the other standing portion is tilted relative to the outer surface of the wing opposing portion, making it possible to arrange the standing portions so that they overlap each other. This makes it possible to further prevent the outer diameter of the balloon from increasing when the balloon is in a deflated state, and as a result, makes it possible to further prevent a decrease in insertability.

In the fourth disclosure, the balloon catheter of the first disclosure has a protrusion extending in the axial direction of the balloon, the balloon is formed in its contracted state and has wing portions folded so as to be convex on one circumferential side of the balloon, the wing portions have a pair of overlapping portions that overlap in the radial direction of the balloon by being folded, one of the standing portions is fixed to one of the pair of overlapping portions and the other standing portion is fixed to the other of the pair of overlapping portions, and when the balloon is in the contracted state, the standing portions face each other across the pair of overlapping portions to be in the tilted state.

According to the fourth disclosure, the wing portion of the balloon has a pair of overlapping portions that overlap in the radial direction of the balloon. Furthermore, one of the standing portions of the protrusion is fixed to one of the overlapping portions, and the other standing portion is fixed to the other overlapping portion. When the balloon is in a deflated state, the standing portions face each other across the pair of overlapping portions, resulting in a tilted state. In this case, when the balloon is in a deflated state, it is possible to prevent the outer diameter of the balloon from increasing, and thus to prevent a decrease in insertability.

The balloon catheter of the fifth disclosure is the same as that of the first disclosure, in which the raised portions rise so as to approach each other as they move away from the outer surface, and the ends of the raised portions that move away from each other are connected to each other to form the apex of the protrusion, and each raised portion is foldable along the apex.

According to the fifth disclosure, the upright portions rise so as to approach each other as they move away from the outer surface of the balloon. In addition, the ends of the upright portions that are farther from the outer surface of the balloon are connected to each other, whereby the tops of the protrusions are formed by the upright portions. With this configuration, when expanding a lesion in the body by inflating the balloon, an incision can be made in the lesion using the tops of the protrusions. Therefore, even if the lesion has hardened, the incision can be used as a trigger to make it easier to expand the lesion.

In addition, since each standing portion can be folded along the apex of the protruding portion, the balloon can be prevented from becoming larger in outer diameter by tilting each standing portion in a folded state. This makes it possible to prevent a decrease in insertability in a configuration having a protruding portion for forming an incision.

In the balloon catheter of the sixth disclosure, in the fifth disclosure, the protrusion extends in the axial direction of the balloon, and the balloon is formed in its contracted state and has a wing portion that is folded circumferentially of the balloon and a wing opposing portion that faces the wing portion on the inner side of the wing portion, and one of the standing portions is fixed to the wing portion and the other is fixed to the wing opposing portion, and when the balloon is in the contracted state, the standing portions are sandwiched between the wing portion and the wing opposing portion, so that they are folded over each other and in the tilted state.

According to the sixth disclosure, in a configuration having a protrusion for forming a notch, the same effects as those of the second and third disclosures can be obtained.

The balloon catheter of the seventh disclosure is the same as the fifth or sixth disclosure, and is provided with a connecting portion that connects the upright portions to prevent the upright portions from opening in the direction away from each other, and the connecting portion is capable of deforming in accordance with the folding of the upright portions.

According to the seventh disclosure, a connecting portion is provided that connects each standing portion, and the connecting portion prevents each standing portion from opening in the direction away from each other. In this case, the top of the protrusion can be prevented from opening when making an incision in the lesion. Therefore, it is possible to prevent the top from opening, which makes it difficult to make an incision in the lesion.

In addition, because the connecting parts are deformable in response to the folding of each standing part, it is possible to prevent the connecting parts from interfering with the folding of each standing part. Therefore, even in a configuration that includes connecting parts, it is possible to effectively prevent a decrease in insertion ability.

The balloon catheter of the eighth disclosure is the balloon catheter of the fifth or sixth disclosure, which is provided with a support portion that is arranged between each of the upright portions and straddles the apex and the outer surface to support the apex, and the support portion is fixed to only one of the apex or the outer surface.

According to the eighth disclosure, a support portion is provided across the apex of the protrusion and the outer surface of the balloon, and the apex is supported by the support portion. In this case, when the apex is used to make an incision in the lesion, the load acting on the apex from the lesion side can be received by the support portion. Therefore, when the apex is used to make an incision, the apex can be suitably prevented from collapsing. This allows the lesion to be incised in a more stable state.

In addition, the support portion is fixed to only one of the top of the protrusion or the outer surface of the balloon. In this case, when each standing portion is folded, the folding can be prevented from being hindered by the support portion. Therefore, even in a configuration having a support portion, a decrease in insertability can be preferably prevented.

The ninth disclosure of the balloon catheter is, in any one of the first to sixth disclosures, such that the protrusion connects the upright portions to each other and has a connecting portion that extends in the direction in which the upright portions stand and is in contact with the outer surface, and the connecting portion is capable of being folded and deformed as the upright portions approach each other.

According to the ninth disclosure, the protrusion has a connection portion that connects each of the upright portions. The connection portion extends in the direction in which each of the upright portions rises, and is provided in a state of contact with the outer surface of the balloon. In this case, a load acting on the protrusion from the diseased area side can be applied to each of the upright portions and supported by the connection portion. Therefore, it is possible to suitably prevent the protrusion from being crushed by the above-mentioned load.

The connection portion is also capable of being folded and deformed as the standing portions approach each other. In this case, when the standing portions approach each other by being folded, etc., the connection portion can be prevented from interfering with the approach. This makes it possible to suitably prevent a decrease in insertability even in a configuration in which the standing portions are connected by the connection portion.

The balloon catheter of the 10th disclosure is the 9th disclosure, in which the connection portion is not fixed to the outer surface.

According to the tenth disclosure, since the connection part is not fixed to the outer surface of the balloon, the connection part is easily folded and deformed in accordance with the approach of each upright part. Therefore, when the upright parts approach each other, the approach can be further prevented from being hindered by the connection part.

The above and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings.
1 is a schematic overall side view showing the configuration of a balloon catheter in a first embodiment. FIG. FIG. 2 is a side view showing the balloon and its surrounding configuration in an inflated state, with the balloon and outer tube shown in longitudinal cross section. (a) is a side view showing the balloon and its surrounding configuration in an inflated state, (b) is a cross-sectional view taken along line A-A in (a), and (c) is a cross-sectional view showing an enlarged protrusion in (b). FIG. 1A is a side view showing the balloon and its surrounding configuration in a contracted state, and FIG. 1B is a cross-sectional view taken along line BB of FIG. 10A and 10B are cross-sectional views showing the periphery of a protrusion in a second embodiment, in which (a) shows a state in which each standing portion is standing, and (b) shows a state in which each standing portion is folded. 13A and 13B are cross-sectional views showing the periphery of a protrusion in a third embodiment, in which (a) shows a state in which each standing portion is standing, and (b) shows a state in which each standing portion is folded. 13A and 13B are perspective views showing the periphery of the connection portion of the protrusion in the fourth embodiment, in which (a) shows a state in which each standing portion is standing, and (b) shows a state in which each standing portion is folded. 13A and 13B are views showing another embodiment of the protrusion. 13A and 13B are views showing another embodiment of the protrusion. 13A and 13B are views showing another embodiment of the protrusion. 13A and 13B are views showing another embodiment of the protrusion.

[First embodiment]
An embodiment of a balloon catheter will now be described with reference to the drawings. First, a schematic configuration of a balloon catheter 10 will be described with reference to Fig. 1. Fig. 1 is a schematic overall side view showing the configuration of the balloon catheter 10.

As shown in FIG. 1, the balloon catheter 10 comprises a catheter body 11, a hub 12 attached to the proximal end (base end) of the catheter body 11, and a balloon 13 attached to the distal end (tip end) of the catheter body 11.

The catheter body 11 comprises an outer tube 15 and an inner tube 16 inserted into the outer tube 15. The outer tube 15 is formed in a tubular shape from a resin material and has an inner lumen 15a (see FIG. 2) extending throughout the entire axial direction. The proximal end of the outer tube 15 is joined to the hub 12, and the distal end of the outer tube 15 is joined to the balloon 13. The inner lumen 15a of the outer tube 15 is connected to the inside of the hub 12 and to the inside of the balloon 13. The inner lumen 15a of the outer tube 15 is a fluid lumen through which a compressed fluid flows when the balloon 13 is inflated or deflated.

The inner tube 16 is made of a resin material and has a lumen 16a (see FIG. 2) that extends in the axial direction. The proximal end of the inner tube 16 is joined to the middle of the axial direction of the outer tube 15. The distal end of the inner tube 16 extends distally beyond the distal end of the outer tube 15, and the extended portion is inserted into the balloon 13.

The inner lumen 16a of the inner tube 16 is a guidewire lumen through which a guidewire G is inserted. The proximal end opening 18 of the inner lumen 16a is located midway along the axial direction of the balloon catheter 10. Therefore, the present balloon catheter 10 is an RX type catheter. The proximal end opening 18 of the inner lumen 16a may be located at the proximal end of the balloon catheter 10. In that case, the balloon catheter 10 is an over-the-wire type catheter.

Next, the balloon 13 and its surrounding configuration will be described with reference to Figures 2 to 4. Figure 2 is a side view showing the balloon 13 and its surrounding configuration in an inflated state, with the balloon 13 and the outer tube 15 shown in longitudinal section. Figure 3 shows, in (a) a side view of the balloon 13 and its surrounding configuration in an inflated state, (b) a cross-sectional view taken along line A-A of (a), and (c) a cross-sectional view showing an enlarged view of the protruding portion 30 in (b). Figure 4 shows, in (a) a side view of the balloon 13 and its surrounding configuration in a contracted state, and (b) a cross-sectional view taken along line B-B of (a). Note that Figure 4(b) shows a state that is more enlarged than Figure 4(a).

The balloon 13 is formed from a thermoplastic resin material, for example, polyamide elastomer. As shown in Figures 2 and 3, the balloon 13 is formed in a cylindrical (tubular) shape with a circular cross section as a whole. Specifically, the balloon 13 has a proximal joint portion 13a, a proximal tapered portion 13b, a straight tube portion 13c, a distal tapered portion 13d, and a distal joint portion 13e, and these portions 13a to 13e are arranged in the above order from the proximal side to the distal side.

The proximal joint 13a is joined to the distal end of the outer tube 15. The proximal taper section 13b is expanded from the distal end of the proximal joint 13a toward the distal side, forming a tapered shape. The straight tube section 13c extends from the distal end of the proximal taper section 13b toward the distal side with a constant diameter, forming a circular tube shape. The straight tube section 13c is the part whose diameter becomes the largest when the balloon 13 is inflated. The distal taper section 13d is reduced in diameter from the distal end of the straight tube section 13c toward the distal side, forming a tapered shape. The distal joint section 13e is joined to the distal end side of the inner tube 16. In addition, in the balloon 13, the proximal taper section 13b, the straight tube section 13c, and the distal taper section 13d constitute an expansion and contraction section that performs expansion and contraction.

When compressed fluid is supplied to the inside of the balloon 13 through the inner cavity 15a of the outer tube 15, the balloon 13 is inflated. On the other hand, when negative pressure is applied to the inner cavity 15a of the outer tube 15 and the compressed fluid is discharged from the inside of the balloon 13, the balloon 13 is in a deflated state.

4(a) and (b), the balloon 13 has a plurality of (three in this embodiment) wing portions 21 formed in the contracted state. Each of these wing portions 21 protrudes radially outward from the balloon 13 in a wing-like shape and is provided at a predetermined interval (more specifically, at equal intervals) around the circumference of the balloon 13. Each wing portion 21 is formed to extend in the axial direction of the balloon 13 in the inflation/deflation portion of the balloon 13 (the proximal taper portion 13b, the straight tube portion 13c, and the distal taper portion 13d).

Each wing portion 21 is arranged so as to be folded along the circumferential direction of the balloon 13 (in other words, the circumferential direction of the inner tube 16). The portion of the balloon 13 arranged on the inner circumferential side of the wing portion 21 is a wing opposing portion 22 that faces the wing portion 21, and the wing portion 21 is folded against this wing opposing portion 22. As a result, the wing portion 21 and the wing opposing portion 22 face each other in the radial direction of the balloon 13, and more specifically, the outer surface 27 of the wing portion 21 and the outer surface 27 of the wing opposing portion 22 face each other in the radial direction of the balloon 13.

Each wing portion 21 is folded so as to be convex on one side in the circumferential direction of the balloon 13, and has a pair of overlapping portions 21a, 21b that overlap in the radial direction of the balloon 13 due to the folding. Of each overlapping portion 21a, 21b, overlapping portion 21a is disposed on the radial inside of the balloon 13, and overlapping portion 21b is disposed on the radial outside of the balloon 13. In this case, overlapping portion 21a faces wing opposing portion 22 in the radial direction of the balloon 13.

A pair of contrast rings 25 are attached to the inside of the balloon 13 in the inner tube 16. The contrast rings 25 are intended to improve the visibility of the balloon 13 under X-ray projection and to facilitate positioning of the balloon 13 at the desired treatment site.

Here, in the present balloon catheter 10, a linear protrusion 30 is provided on the outer surface 27 of the balloon 13. The protrusion 30 is for making an incision in the lesion when the balloon 13 is inflated to expand the lesion. In the present balloon catheter 10, even if the lesion has hardened due to calcification or the like, it is possible to make an incision in the lesion with the protrusion 30, and use the incision as a trigger to expand the lesion. Therefore, the present balloon catheter 10 is configured as a balloon catheter with a scoring function. The configuration of the protrusion 30 will be described below. In addition, the protrusion 30 will be described below based on the expansion state of the balloon 13.

2, 3(a) and 3(b), the protrusions 30 are provided protruding from the outer surface 27 of the balloon 13 and extend linearly along the axial direction of the balloon 13. The protrusions 30 are arranged at a predetermined interval (more specifically, at equal intervals) in the circumferential direction of the balloon 13, and in this embodiment, three protrusions 30 are arranged. Therefore, in this embodiment, the number of protrusions 30 is the same as the number of wing portions 21. The protrusions 30 are provided on the straight tube portion 13c of the balloon 13, more specifically, only on the straight tube portion 13c. However, the protrusions 30 may be provided on the proximal taper portion 13b or the distal taper portion 13d instead of or in addition to the straight tube portion 13c of the balloon 13.

3(c), the protruding portion 30 has a pair of standing portions 31 that stand up from the outer surface 27 of the balloon 13. Each standing portion 31 is in the form of a plate extending in the longitudinal direction of the protruding portion 30, and is formed, for example, from a resin material. The standing portions 31 are disposed opposite each other in the circumferential direction of the balloon 13, and more specifically, are disposed at an angle so that they approach each other as they move away from the outer surface 27 of the balloon 13.

The tips of the rising portions 31 in the rising direction (the ends on the side away from the outer surface 27) are joined (fixed) to each other by welding or adhesion. As a result, the rising portions 31 form a mountain-shaped protrusion 30. The joints of the rising portions 31 form the tops 33 of the protrusions 30, which make it possible to make incisions in the affected area. A hollow portion 34 is formed between the rising portions 31, so that the protrusions 30 are hollow protrusions. In this embodiment, the thickness of the rising portions 31 becomes smaller toward the tip side of the rising portions 31, but the thickness of the rising portions 31 may be constant over the entire rising direction of the rising portions 31, for example.

Each standing portion 31 is fixed to the outer surface 27 of the balloon 13 by welding or adhesive at its base end (the end on the outer surface 27 side) opposite the tip end. In this case, in addition to the tips of each standing portion 31 being fixed to each other, the base end is fixed to the outer surface 27 of the balloon 13. Therefore, even if the protruding portion 30 is configured to be hollow, when an incision is made in the lesion with the protruding portion 30, the protruding portion 30 is unlikely to be crushed, and the incision can be made in a stable state.

Each standing portion 31 is arranged so as to be tiltable relative to the outer surface 27 of the balloon 13 (see also FIG. 4(b)). Each standing portion 31 is also foldable along the apex 33. Here, in the present balloon catheter 10, when the balloon 13 is contracted, each standing portion 31 is folded as the balloon 13 contracts, and is configured to tilt in the folded state. Therefore, the configuration of each standing portion 31 when the balloon 13 is in the contracted state will be described below with reference to FIGS. 4(a) and (b).

4(a) and (b), when the balloon 13 is in a contracted state, as described above, a plurality of wing portions 21 are formed on the balloon 13. Each protrusion 30 is provided in a one-to-one relationship with a wing portion 21, and is disposed in a state sandwiched between the wing portion 21 and the wing opposing portion 22. Each standing portion 31 of the protrusion 30 is sandwiched between the wing portion 21 and the wing opposing portion 22, and is inclined in a folded state relative to each other. In this case, each standing portion 31A, 31B is folded so as to overlap in the radial direction of the balloon 13.

Of each of the standing portions 31, one standing portion 31A is fixed to the outer surface 27 of the wing portion 21 (more specifically, the overlapping portion 21a), and the other standing portion 31B is fixed to the outer surface 27 of the wing opposing portion 22. The standing portion 31A is inclined toward the outer surface 27 of the wing portion 21 (overlapping portion 21a) and is arranged so as to follow the outer surface 27. The standing portion 31B is inclined toward the outer surface 27 of the wing opposing portion 22 and is arranged so as to follow the outer surface 27. These inclined standing portions 31A, 31B are folded up against each other. In the folded state of each of the standing portions 31A, 31B, the top 33 of the protrusion 30 faces one side in the circumferential direction of the balloon 13, more specifically, faces the same side as the tip of the wing portion 21.

Next, we will explain how to use the balloon catheter 10. Here, we will explain the procedure for dilating a lesion that has occurred in a blood vessel using the balloon catheter 10.

First, a guiding catheter is inserted into a sheath introducer inserted into a blood vessel, and the tip opening of the guiding catheter is introduced to the coronary artery entrance. Next, a guidewire G is inserted into the guiding catheter, and the guidewire G is introduced from the coronary artery entrance through the lesion to the peripheral site.

Next, the balloon catheter 10 is introduced into the guiding catheter along the guide wire G. After the introduction, the balloon 13 is introduced toward the lesion while being pushed and pulled. During this introduction, the balloon 13 is in a contracted state. As described above, when the balloon 13 is in a contracted state, the upright portions 31 of the protrusions 30 are inclined in a mutually folded state (see Figs. 4(a) and (b)). Therefore, in a configuration in which the protrusions 30 are provided on the outer surface 27 of the balloon 13, it is possible to prevent the outer diameter of the balloon 13 from increasing. This makes it possible to prevent a decrease in the insertability when the balloon 13 is introduced toward the lesion.

When the balloon 13 reaches the lesion, the balloon 13 is inflated. When the balloon 13 is inflated, the upright portions 31 of the protrusions 30 open away from each other and stand up from the outer surface 27 of the balloon 13 (see FIG. 3(c)). In more detail, in this case, the wing portions 21 unfold due to the expansion of the balloon 13, and the balloon 13 becomes cylindrical, and accordingly, the upright portions 31 fixed to the outer surface 27 of the balloon 13 open in the circumferential direction of the balloon 13 and stand up.

When the balloon 13 is inflated and each of the upright portions 31 is in an upright state, the protrusions 30 are pressed against the lesion, causing cuts (cracks) in the lesion. This allows the lesion to be expanded by destroying the lesion using the cuts as a trigger.

After the balloon 13 has completed expanding the lesion, the balloon 13 is deflated. This causes the protruding portion 30 to be sandwiched between the wing portion 21 and the wing opposing portion 22, and each upright portion 31 is tilted in a folded state (see Figures 4(a) and (b)). Then, in this deflated state, the balloon catheter 10 is pulled out of the body. This completes the series of operations.

As described above, the balloon catheter 10 is primarily used by passing it through blood vessels to treat blood vessels such as the coronary arteries, femoral arteries, and pulmonary arteries, but it can also be applied to "tubes" and "body cavities" within the body other than blood vessels, such as the urinary tract and digestive tract.

The configuration of this embodiment described above in detail provides the following excellent effects.

When the balloon 13 is in a contracted state, each standing portion 31 is sandwiched between the wing portion 21 and the wing opposing portion 22 and is in a tilted state. In this case, it is possible to prevent the outer diameter of the balloon 13 from increasing when the balloon 13 is in a contracted state. Therefore, it is possible to prevent a decrease in the insertability when the balloon 13 is inserted into the body in a contracted state.

In addition, because each standing portion 31 is sandwiched between the wing portion 21 and the wing opposing portion 22, the tilted state of each standing portion 31 is easily maintained. This makes it possible to effectively prevent the outer diameter of the balloon 13 from increasing, and as a result, makes it possible to effectively prevent a decrease in insertability.

One of the standing portions 31, 31A, is fixed to the wing portion 21, and the other standing portion 31B is fixed to the wing opposing portion 22. In this case, when each standing portion 31 (31A, 31B) is sandwiched between the wing portion 21 and the wing opposing portion 22, the standing portion 31A is tilted relative to the outer surface 27 of the wing portion 21, and the standing portion 31B is tilted relative to the outer surface 27 of the wing opposing portion 22, making it easier to arrange the standing portions 31A, 31B in an overlapping state, i.e., in a folded state. This makes it possible to further prevent the outer diameter of the balloon 13 from increasing when the balloon 13 is in a contracted state, and as a result, to further prevent a decrease in insertability.

In addition, when the balloon 13 is contracted, each standing portion 31 is naturally sandwiched between the wing portion 21 and the wing opposing portion 22 and is in a folded (inclined) state, which makes it convenient for inserting the balloon 13 into the body while repeatedly expanding and contracting the balloon 13.

Second Embodiment
Next, a second embodiment will be described. In this embodiment, the protrusion 30 is provided with a connecting portion that connects the standing portions 31, and in this respect, the configuration is different from the first embodiment. Therefore, the configuration of this embodiment will be described below, focusing on the difference. FIG. 5 is a cross-sectional view showing the periphery of the protrusion 30 in this embodiment, in which (a) shows the standing portions 31 in an erected state, and (b) shows the standing portions 31 in a folded state. In addition, in FIG. 5(a), the balloon 13 is in an expanded state, and in (b), the balloon 13 is in a contracted state. In addition, in FIG. 5(b), a state in which the standing portions 31 are folded between the wing portion 21 and the wing opposing portion 22 of the balloon 13 is simply shown (these points are the same as in FIGS. 6(a) and (b) described later).

As shown in FIG. 5(a), the protruding portion 30 is provided with a connecting portion 40 that connects each of the standing portions 31. The connecting portion 40 is formed in a plate shape extending in the longitudinal direction of the protruding portion 30, and both ends in the width direction are fixed to each of the standing portions 31. The connecting portion 40 also connects the middle portion of each of the standing portions 31 in the standing direction, more specifically, the approximate center portion. In this case, the connecting portion 40 prevents each of the standing portions 31 from opening in the direction away from each other.

According to the above configuration, when making an incision in the lesion using the apex 33 of the protrusion 30, it is possible to prevent the apex 33 from opening. Therefore, it is possible to prevent the apex 33 from opening, which makes it difficult to make an incision in the lesion.

5(b), a fold 43 is formed in the center of the width of the connecting portion 40, extending along the longitudinal direction of the protruding portion 30. The connecting portion 40 is bendable (flexible) along the fold 43, and more specifically, is bendable so as to be convex on the side opposite the apex 33 of the protruding portion 30.

In this configuration, when the balloon 13 is contracted and each standing portion 31 is folded between the wing portion 21 and the wing opposing portion 22, the connecting portion 40 is bent and deformed accordingly. This makes it possible to prevent the folding of each standing portion 31 from being hindered by the connecting portion 40. As a result, even in a configuration having the connecting portion 40, it is possible to suitably prevent a decrease in the insertability of the balloon 13.

The connecting portion 40 may be provided to connect the tip side of each standing portion 31 in the standing direction, or may be provided to connect the base end side. Also, multiple connecting portions 40 may be provided, in which case the connecting portion 40 may be provided on each of the tip side and base end side of each standing portion 31. Also, the connecting portion 40 does not necessarily have to be plate-shaped, and may be linear. In this case, it is preferable to provide multiple linear connecting portions in the longitudinal direction of each standing portion 31.

In addition, the connecting portion 40 does not necessarily need to be bent so as to be convex on the side opposite the apex 33, but may be bent so as to be convex on the side of the apex 33. In addition, the connecting portion 40 may be provided with a plurality of folds 43 in the width direction of the connecting portion 40, and the connecting portion 40 may be bent and deformed at each of the folds 43.

The connecting portion 40 does not necessarily need to be formed to be able to bend and deform. For example, the connecting portion may be formed of a rubber material or the like so as to be able to expand and contract in the connecting direction connecting each standing portion 31. In this case, when each standing portion 31 is folded between the wing portion 21 and the wing opposing portion 22, the connecting portion will shrink and deform accordingly. Therefore, even with this configuration, it is possible to prevent the connecting portion from interfering with the folding of each standing portion 31.

Third Embodiment
Next, a third embodiment will be described. In this embodiment, a support portion for supporting the top portion 33 is provided on the protruding portion 30, and in this respect, the configuration is different from the first embodiment. Therefore, the configuration of this embodiment will be described below, focusing on the difference. Figure 6 is a cross-sectional view showing the periphery of the protruding portion 30 in this embodiment, where (a) shows the state in which each standing portion 31 is standing, and (b) shows the state in which each standing portion 31 is folded.

As shown in FIG. 6(a), the protrusion 30 is provided with a support portion 50 that extends across the top 33 and the outer surface 27 of the balloon 13. The support portion 50 is formed in a plate shape extending in the longitudinal direction of the protrusion 30, and is disposed between each of the upright portions 31 of the protrusion 30. The support portion 50 is fixed to the top 33, and is not fixed to the outer surface 27 of the balloon 13. Therefore, the support portion 50 is fixed only to the top 33. The top 33 is supported by the support portion 50.

According to the above configuration, when the apex 33 of the protrusion 30 makes an incision in the lesion, the load acting on the apex 33 from the lesion side can be received by the support portion 50. Therefore, when making an incision with the apex 33, the occurrence of crushing of the apex 33 can be suitably suppressed. This allows the incision to be made in the lesion in a more stable state.

In addition, since the support portion 50 is fixed only to the top portion 33, as shown in FIG. 6(b), when each standing portion 31 is folded when the balloon 13 is deflated, the support portion 50 moves away from the outer surface 27 of the balloon 13. This prevents the folding of each standing portion 31 from being hindered by the support portion 50. This makes it possible to suitably prevent a decrease in insertability even in a configuration having the support portion 50.

It should be noted that, instead of fixing the support portion 50 to the apex 33, it may be fixed to the outer surface 27 of the balloon 13. In short, it is sufficient that the support portion 50 is fixed to only one of the apex 33 and the outer surface 27. Also, the support portion 50 does not necessarily have to be plate-shaped, and may be linear. In that case, it is preferable to provide multiple linear support portions in the longitudinal direction of the protruding portion 30.

[Fourth embodiment]
Next, a fourth embodiment will be described. In this embodiment, a connection portion for connecting each standing portion 31 to the protrusion is provided, and in this respect, the configuration is different from the first embodiment. Therefore, the configuration of this embodiment will be described below, focusing on the difference. Fig. 7 is a perspective view showing the periphery of the connection portion 61 of the protrusion 60 in this embodiment, (a) shows a state in which each standing portion 31 is standing, and (b) shows a state in which each standing portion 31 is folded. Note that although the balloon 13 is omitted in Figs. 7(a) and (b), the balloon 13 is in an inflated state in Fig. 7(a) and in a deflated state in Fig. 7(b).

7(a), in addition to each standing portion 31, the protrusion 60 has a pair of connecting portions 61 that connect each standing portion 31. The connecting portions 61 are respectively arranged at both longitudinal ends of the protrusion 60, and connect the longitudinal ends of each standing portion 31. The connecting portions 61 are plate-shaped and are formed, for example, from a resin material. The connecting portions 61 extend in the direction in which each standing portion 31 stands, and more specifically, extend over the entire area in the standing direction. The connecting portions 61 are provided in contact with the outer surface 27 of the balloon 13, and are not fixed to the outer surface 27.

According to the above configuration, when the protrusion 60 makes an incision in the lesion, the load acting on the protrusion 60 from the lesion side can be applied to each upright portion 31 and supported by the connection portion 61. Therefore, it is possible to effectively prevent the protrusion 60 from being crushed by the above load.

In addition, the connection portion 61 has a fold 65 formed therein, which extends from the apex 63 of the protrusion 60 toward the outer surface 27 of the balloon 13. The fold 65 extends along the center of the connection portion 61 in the width direction. The connection portion 61 is folded along this fold 65 so as to be convex outward in the longitudinal direction of the protrusion 60. This allows the connection portion 61 to stably support the load acting on the protrusion 60.

The connection portion 61 can be folded along the crease 65. In this case, the connection portion 61 can be folded so as to protrude outward in the longitudinal direction of the protruding portion 60. With this configuration, as shown in FIG. 7(b), the connection portion 61 can be folded and deformed along the crease 65 in accordance with the folding of the standing portions 31 relative to one another. Therefore, when the standing portions 31 are folded, the folding can be prevented from being hindered by the connection portion 61. As a result, even in a configuration in which the standing portions 31 are connected by the connection portion 61, a decrease in insertability can be suitably prevented.

In addition, because the connection part 61 is not fixed to the outer surface 27 of the balloon 13, the connection part 61 is easily folded and deformed in response to the folding of each standing part 31. Therefore, when each standing part 31 is folded, it is possible to further suppress the folding being hindered by the connection part 61.

Instead of or in addition to arranging the connection portion 61 at the longitudinal end of the protrusion 60, the connection portion 61 may be arranged at the longitudinal middle portion of the protrusion 60. The number of connection portions 61 may be three or more, or may be one. The connection portion 61 may be fixed to the outer surface 27 of the balloon 13.

[Other embodiments]
The present disclosure is not limited to the above embodiment, and may be implemented, for example, as follows.

(1) In the first embodiment described above, one of the standing portions 31 is fixed to the wing portion 21 and the other is fixed to the wing opposing portion 22, but this may be changed. For example, as shown in FIG. 8(b), one of the standing portions 31 may be fixed to the overlapping portion 21a of the wing portion 21 and the other is fixed to the overlapping portion 21b. Note that FIG. 8(b) shows the contracted state of the balloon 13. Also, FIG. 8(a) shows, for reference, the standing state of each standing portion 31 when the balloon 13 is inflated.

In the above configuration, when the balloon 13 is in a contracted state, the standing portions 31 are in a tilted state by facing each other across the wing portion 21 (each overlapping portion 21a, 21b). In more detail, the standing portion 31 fixed to the overlapping portion 21a is inclined relative to the outer surface 27 of the overlapping portion 21a, and the standing portion 31 fixed to the overlapping portion 21b is inclined relative to the outer surface 27 of the overlapping portion 21b. This makes it possible to prevent the outer diameter of the balloon 13 from increasing when the balloon 13 is in a contracted state, and thus to prevent a decrease in insertability.

(2) The shape of the protrusion 30 is not necessarily limited to that of the first embodiment. For example, the protrusion 70 shown in FIG. 9(a) has first portions 72 that rise parallel to each other from the outer surface 27 of the balloon 13, and second portions 73 that rise from the first portions 72 so as to approach each other. Therefore, the rising portions 71 rise so as to approach each other as they move away from the outer surface 27 as a whole. The rising portions 71 are joined to each other at their tips (i.e., the ends on the side away from the outer surface 27), and the apex 75 of the protrusion 70 is formed by this joining. As a result, even with such a protrusion 70, it is possible to make an incision in the lesion with the apex 75.

Each standing portion 71 can be tilted along the apex 75. Therefore, as shown in FIG. 9(b), when the balloon 13 is in a contracted state, each standing portion 71 is sandwiched between the wing portion 21 and the wing opposing portion 22 and tilted in a folded state. This makes it possible to preferably prevent the outer diameter of the balloon 13 from increasing due to the protrusion 70.

(3) Figures 10(a) to (c) show another form of the protrusion 80. As shown in Figures 10(a) and (b), the protrusion 80 has a pair of standing parts 81 that stand up parallel to each other, and a pair of connecting parts 82 that connect the standing parts 81. Each connecting part 82 is disposed at both ends of the pair of standing parts 81 in the longitudinal direction, and connects the ends of the standing parts 81 to each other. Each connecting part 82 extends in the standing direction of each standing part 81, and is provided in contact with the outer surface 27 of the balloon 13. As a result, according to the protrusion 80 of this example, the load acting on the protrusion 80 from the diseased part side can be applied to each standing part 81 and also supported by the connecting part 82.

The connection portion 82 is folded along the crease 85 extending in the direction in which the standing portion 81 stands, thereby forming a mountain shape that is convex outward in the longitudinal direction of the protruding portion 80. The connection portion 82 is also foldable along the crease 85. As a result, as shown in FIG. 10(c), when the standing portions 81 are sandwiched between the wing portion 21 and the wing opposing portion 22 as the balloon 13 contracts, the standing portions 81 approach each other and overlap, and the connection portion 82 folds and deforms along the crease 85 in response to this approach. Therefore, according to the protruding portion 80 of this example, even in a configuration having the connection portion 82, it is possible to suitably suppress a decrease in insertability.

(4) Figures 11(a) to (c) show another form of the protrusion 90. As shown in Figure 11(a), the protrusion 90 has a pair of standing portions 91 and a bridge portion 92 that spans the tip end of each standing portion 91. As shown in Figures 11(b) and (c), when each standing portion 91 is tilted toward the outer surface 27 of the balloon 13, the protrusion 90 as a whole is in a tilted state. Therefore, such a protrusion 90 can also prevent the outer diameter of the balloon 13 from increasing, and as a result, the deterioration of the insertability can be suitably prevented. Note that a bridge portion may also be provided to span the base end of each standing portion 91.

(5) In each of the above embodiments, the standing portion 31 is formed in a plate shape, but the standing portion may be formed in a frame shape. In this case, the frame shape is formed by combining linear elements.

(6) In each of the above embodiments, the protruding portion 30 is formed by joining the upright portions 31 to each other, but the protruding portion 30 may be formed, for example, by bending a long plate material along a crease extending in the longitudinal direction. In this case, both sides of the crease become the upright portions 31, and the crease portion becomes the apex 33.

(7) The protrusion 30 does not necessarily need to be provided continuously in the axial direction of the balloon 13; for example, the protrusion 30 may be divided into multiple parts in the axial direction of the balloon 13.

(8) The protrusion 30 may be provided so as to extend in a direction different from the axial direction of the balloon 13. For example, the protrusion may be provided so as to extend in the circumferential direction of the balloon 13, or so as to extend in a spiral shape around the axis of the balloon 13.

(9) The protrusion 30 may be formed from a material other than a resin material, such as a hard polymer or a metal material.

(10) In each of the above embodiments, each wing portion 21 is folded so as to be convex on one circumferential side (i.e., the same side) of the balloon 13, but, for example, some of the wing portions 21 may be folded so as to be convex on the other circumferential side of the balloon 13.

(11) In addition to the protrusion 30 for making an incision in the lesion, the protrusion may also include a protrusion for applying a drug to the lesion and a protrusion for preventing the balloon 13 from slipping. Therefore, the present disclosure may be applied to these protrusions.

Although the present disclosure has been described with reference to an embodiment, it is understood that the present disclosure is not limited to the embodiment or structure. The present disclosure also encompasses various modifications and modifications within the scope of equivalents. In addition, various combinations and forms, as well as other combinations and forms including only one element, more than one element, or less than one element, are also within the scope and spirit of the present disclosure.

10...balloon catheter, 13...balloon, 21...wing portion, 22...wing opposing portion, 27...outer surface, 30...protruding portion, 31...standing portion, 33...top, 40...connecting portion, 50...support portion, 61...connecting portion.

Claims (10)

a balloon that is inflatable and deflatable;
a protrusion provided on an outer surface of the balloon and extending linearly along the outer surface,
The protrusion has a pair of upstanding portions extending in a longitudinal direction of the protrusion and standing upright from the outer surface and facing each other,
The protrusion is formed by connecting the upright portions to each other,
A balloon catheter, wherein each of the upright portions is tiltable relative to the outer surface. The protrusion extends in an axial direction of the balloon,
The balloon is
A wing portion is formed in the contracted state and folded along the circumferential direction of the balloon;
a blade opposing portion that is opposed to the blade portion on an inner peripheral side of the blade portion,
2. The balloon catheter according to claim 1, wherein when the balloon is in the deflated state, each of the upright portions is sandwiched between the wing portion and the wing opposing portion and is in the inclined state. The balloon catheter according to claim 2, wherein one of the raised portions is fixed to the wing portion and the other is fixed to the wing opposing portion. The protrusion extends in an axial direction of the balloon,
The balloon has a wing portion that is formed in a deflated state and is folded so as to be convex on one side in a circumferential direction of the balloon,
The wing portion has a pair of overlapping portions that overlap in a radial direction of the balloon by being folded,
One of the standing portions is fixed to one of the pair of overlapping portions,
the other standing portion is fixed to the other of the pair of overlapping portions,
The balloon catheter according to claim 1 , wherein when the balloon is in the deflated state, the upright portions are opposed to each other with the pair of overlapping portions therebetween, thereby being in the tilted state. the upright portions are raised so as to approach each other as they move away from the outer surface, and the ends of the upright portions on the farther side are connected to each other to form a top of the protrusion,
The balloon catheter according to claim 1 , wherein each of the upstanding portions is foldable along the apex. The protrusion extends in an axial direction of the balloon,
The balloon is
A wing portion is formed in the contracted state and folded along the circumferential direction of the balloon;
a blade opposing portion that is opposed to the blade portion on an inner peripheral side of the blade portion,
One of the upright portions is fixed to the blade portion, and the other is fixed to the blade opposing portion,
6. The balloon catheter according to claim 5, wherein when the balloon is in the deflated state, the upright portions are sandwiched between the wing portions and the wing opposing portions, so that the upright portions are folded over each other and in the tilted state. a connecting portion that connects the upright portions to each other to suppress the upright portions from opening in a direction away from each other,
The balloon catheter according to claim 5 or 6, wherein the connecting portion is deformable in response to the folding of the upright portions. a support portion provided between each of the upright portions and spanning the top and the outer surface to support the top,
The balloon catheter according to claim 5 or 6, wherein the support portion is fixed to only one of the apex portion and the outer surface. the protrusion has a connection portion that connects the upright portions to each other, extends in a direction in which the upright portions stand, and is provided in a state of being in contact with the outer surface,
The balloon catheter according to claim 1 , wherein the connecting portion is foldable and deformable in accordance with the approach of the upstanding portions to each other. The balloon catheter of claim 9, wherein the connection portion is not fixed to the outer surface.

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