Balloon catheter

Abstract

A balloon catheter comprises a balloon 13 and a protruding part 30 that is provided so as to protrude from the outer surface 27 of the balloon 13 and that extends linearly along the axial direction of the balloon 13. The protruding part 30 has a pair of upright portions 31 that extend along the lengthwise direction of the protruding part 30, stand upright from the outer surface 27 of the balloon 13, and face one another. The upright portions 31 are disposed in an inclined manner so as to approach each other in the direction away from the outer surface 27 of the balloon 13, and the ends of the upright portions 31 on the side away from the outer surface 27 connect to each other so as to form the apex 33 of the protruding part 30. The upright portions 31 are provided so as to be collapsible onto the outer surface 27 of the balloon 13.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is based on Japanese Application No. 2022-111430 filed on July 11, 2022, the contents of which are incorporated herein by reference. [Technical field]

[0002] The present disclosure relates to balloon catheters. [Background technology]

[0003] Balloon catheters have been used in the past for treatments such as PTA (percutaneous transluminal angioplasty) and PTCA (percutaneous transluminal coronary angioplasty). A balloon catheter is equipped with an expandable and contractable balloon at its distal end. With a balloon catheter, the balloon is introduced in a contracted state to a site narrowed or blocked by a lesion or the like that has occurred in a blood vessel, and then the balloon is expanded to expand the site.

[0004] 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 of protruding from the outer surface of the balloon. In the balloon catheter 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 making the elements bite into the lesion. In this balloon catheter, the incision made in the lesion can be used as a trigger to facilitate the dilation of the lesion. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 5600745 Summary of the Invention [Problem to be solved by the invention]

[0006] However, in the above-mentioned balloon catheter with elements, the outer diameter of the balloon is increased by the amount of the elements provided on the outer surface of the balloon, which may reduce the ease of insertion of the balloon into the body.

[0007] The present disclosure has been made in consideration of the above circumstances, and has as its primary objective to suppress a decrease in insertability in a balloon catheter having linear protrusions on the outer surface of the balloon. [Means for solving the problem]

[0008] In order to solve the above problems, the balloon catheter of the first disclosure is a balloon catheter comprising an inflatable and deflatable balloon, and a protrusion that protrudes from the outer surface of the balloon and extends linearly along the outer surface, the protrusion extending in the longitudinal direction of the protrusion and having a pair of opposing upright portions that rise from the outer surface, the upright portions being connected to each other to form the protrusion, and each of the upright portions being tiltable relative to the outer surface.

[0009] 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 extending in the longitudinal direction of the protrusion and standing up from the outer surface of the balloon. These standing parts face each other, and the protrusion is configured 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 made to be in a tilted state by tilting each standing part. Therefore, in a configuration in which the 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 the balloon is inserted into the body.

[0010] The balloon catheter of the second disclosure is the same as that of the first disclosure, wherein 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 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.

[0011] According to the second disclosure, when the balloon is in a contracted 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 contracted state. Therefore, it is possible to prevent a decrease in insertability when the balloon is inserted into the body in a contracted state.

[0012] In addition, since each standing portion is sandwiched between the blade portion and the blade opposing portion, the tilted state of each standing portion can be easily maintained. This makes it possible to preferably 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 preferably prevent a decrease in insertability.

[0013] The balloon catheter of the third disclosure is the balloon catheter 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.

[0014] 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 inclined relative to the outer surface of the wing portion, and the other standing portion is inclined relative to the outer surface of the wing opposing portion, so that each standing portion can be arranged to 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, to further prevent a decrease in insertability.

[0015] The balloon catheter of the fourth disclosure is the balloon catheter of the first disclosure, wherein the protrusion extends in the axial direction of the balloon, the balloon has wing portions that are formed in its deflated state and are 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 deflated state, the standing portions face each other across the pair of overlapping portions, thereby being in the tilted state.

[0016] 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. In addition, 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.

[0017] The balloon catheter of the fifth disclosure is the balloon catheter of the first disclosure, wherein 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 are spaced apart are connected to each other to form an apex of the protrusion, and the raised portions are foldable along the apex.

[0018] 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, so that the tops of the protruding portions 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 protruding portions. Therefore, even if the lesion has hardened, the incision can be used as a trigger to make it easier to expand the lesion.

[0019] In addition, since each standing portion can be folded along the apex of the protruding portion, the outside diameter of the balloon can be prevented from increasing 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.

[0020] The balloon catheter of the sixth disclosure is the balloon catheter of the fifth disclosure, wherein the protrusion extends in the axial direction of the balloon, and the balloon has a wing portion that is formed in its contracted state and 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, and are folded over each other in the tilted state.

[0021] According to the sixth disclosure, in a configuration having a protruding portion for forming a notch, it is possible to obtain the same effects as those of the second and third disclosures.

[0022] The balloon catheter of the seventh disclosure is the balloon catheter of the fifth or sixth disclosure, which 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 response to the upright portions being folded.

[0023] According to the seventh disclosure, a connecting portion is provided to connect the upright portions, and the connecting portion prevents the upright portions from opening in a direction away from each other. In this case, when the top of the protrusion is used to make an incision in the lesion, the top can be prevented from opening. Therefore, it is possible to prevent the top from opening, which makes it difficult to make an incision in the lesion.

[0024] In addition, since the connecting portion is deformable in response to the folding of each standing portion, it is possible to prevent the connecting portion from interfering with the folding of each standing portion. Therefore, even in a configuration having a connecting portion, it is possible to suitably prevent a decrease in insertability.

[0025] 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 spans 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.

[0026] 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 being crushed. This allows the lesion to be incised in a more stable state.

[0027] In addition, the support portion is fixed to only one of the top of the protrusion and 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.

[0028] The ninth disclosure is a balloon catheter in any one of the first to sixth disclosures, wherein the protrusion connects the upright portions to each other and has a connecting portion extending in the direction in which the upright portions stand and in contact with the outer surface, and the connecting portion is capable of being folded and deformed as the upright portions approach each other.

[0029] According to the ninth disclosure, the protrusion has a connection part that connects each of the upright parts. The connection part extends in the direction in which each of the upright parts stands, and is provided in a state of contact with the outer surface of the balloon. In this case, the load acting on the protrusion from the lesion side can be applied to each of the upright parts and supported by the connection part. Therefore, it is possible to suitably suppress the occurrence of crushing of the protrusion due to the above-mentioned load.

[0030] In addition, the connecting portion is foldable and deformable in accordance with the approach of the standing portions to each other. In this case, when the standing portions are folded or otherwise brought closer to each other, the connecting portion can be prevented from interfering with the approach. As a result, even in a configuration in which the standing portions are connected by the connecting portion, a decrease in insertability can be suitably prevented.

[0031] The balloon catheter of a tenth disclosure is the ninth disclosure, wherein the connection portion is not fixed to the outer surface.

[0032] According to the tenth disclosure, since the connection parts are not fixed to the outer surface of the balloon, the connection parts are easily folded and deformed in accordance with the approach of the upright parts, and therefore, when the upright parts approach each other, the approach can be further prevented from being hindered by the connection parts. [Brief description of the drawings]

[0033] 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. [Figure 1] 1 is a schematic overall side view showing the configuration of a balloon catheter in a first embodiment. [Diagram 2] 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. [Diagram 3] FIG. 1A is a side view showing the balloon and its surrounding configuration in an inflated state, FIG. 1B is a cross-sectional view taken along line AA of FIG. 1A, and FIG. 1C is an enlarged cross-sectional view showing a protrusion in FIG. [Figure 4] FIG. 4A is a side view showing the balloon and its surrounding configuration in a contracted state, and FIG. 4B is a cross-sectional view taken along line BB in FIG. [Diagram 5] 6A and 6B are cross-sectional views showing the periphery of a protruding portion 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. [Figure 6] 13A and 13B are cross-sectional views showing the periphery of a protruding portion 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. [Figure 7] 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. [Figure 8] 13A and 13B are views showing another embodiment of the protrusion. [Figure 9] 13A and 13B are views showing another embodiment of the protrusion. [Figure 10] 13A and 13B are views showing another embodiment of the protrusion. [Figure 11] 13A and 13B are views showing another embodiment of the protrusion. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] [First embodiment] An embodiment of a balloon catheter will now be described with reference to the drawings. First, the 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.

[0035] 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.

[0036] The catheter main body 11 includes an outer tube 15 and an inner tube 16 inserted into the outer tube 15. The outer tube 15 is made of a resin material and has a lumen 15a (see FIG. 2) extending therein in 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 lumen 15a of the outer tube 15 communicates with the inside of the hub 12 and with the inside of the balloon 13. The lumen 15a of the outer tube 15 serves as a fluid lumen through which a compressed fluid flows when the balloon 13 is inflated or deflated.

[0037] The inner tube 16 is made of a resin material and has a tubular shape, and has an inner cavity 16a (see FIG. 2) that extends over the entire axial direction. The proximal end of the inner tube 16 is joined to a midpoint in 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.

[0038] The inner lumen 16a of the inner tube 16 serves as a guidewire lumen through which a guidewire G is inserted. A proximal end opening 18 of the inner lumen 16a is located midway in 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.

[0039] Next, the balloon 13 and its surrounding configuration will be described with reference to Figs. 2 to 4. Fig. 2 is a side view showing the balloon 13 and its surrounding configuration in an inflated state, and shows the balloon 13 and the outer tube 15 in a longitudinal cross section. Fig. 3 shows (a) a side view showing the balloon 13 and its surrounding configuration in an inflated state, (b) a cross-sectional view taken along line AA in (a), and (c) a cross-sectional view showing an enlarged view of the protruding portion 30 in (b). Fig. 4 shows (a) a side view showing the balloon 13 and its surrounding configuration in a contracted state, and (b) a cross-sectional view taken along line BB in (a). Fig. 4(b) shows a state enlarged more than Fig. 4(a).

[0040] The balloon 13 is formed of 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 having 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.

[0041] The proximal joint 13a is joined to the distal end of the outer tube 15. The proximal tapered portion 13b is expanded from the distal end of the proximal joint 13a toward the distal side, and is tapered. The straight tube portion 13c extends from the distal end of the proximal tapered portion 13b toward the distal side with a constant diameter, and is tubular. The straight tube portion 13c is the portion whose diameter becomes the largest when the balloon 13 is inflated. The distal tapered portion 13d is reduced in diameter from the distal end of the straight tube portion 13c toward the distal side, and is tapered. The distal joint 13e is joined to the distal end side of the inner tube 16. In the balloon 13, the proximal tapered portion 13b, the straight tube portion 13c, and the distal tapered portion 13d constitute an inflation / contraction portion that performs inflation and contraction.

[0042] When compressed fluid is supplied to the inside of the balloon 13 through the lumen 15a of the outer tube 15, the balloon 13 is expanded. On the other hand, when negative pressure is applied to the lumen 15a of the outer tube 15 and the compressed fluid is discharged from the inside of the balloon 13, the balloon 13 is contracted.

[0043] 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 of the balloon 13 in a wing-like shape, and is provided at a predetermined interval (more specifically, at equal intervals) in the circumferential direction of the balloon 13. Each wing portion 21 is formed so as to extend in the axial direction of the balloon 13 in the inflation / deflation portion of the balloon 13 (the proximal tapered portion 13b, the straight tube portion 13c, and the distal tapered portion 13d).

[0044] Each of the blade portions 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 blade portion 21 is a blade opposing portion 22 that faces the blade portion 21, and the blade portion 21 is folded with respect to this blade opposing portion 22. As a result, the blade portion 21 and the blade opposing portion 22 face each other in the radial direction of the balloon 13, and more specifically, the outer surface 27 of the blade portion 21 and the outer surface 27 of the blade opposing portion 22 face each other in the radial direction of the balloon 13.

[0045] Each wing portion 21 is folded so as to be convex on one side in the circumferential direction of the balloon 13, and the folding results in a pair of overlapping portions 21a, 21b that overlap in the radial direction of the balloon 13. 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.

[0046] A pair of contrast rings 25 are attached to the inner tube 16 on the inside of the balloon 13. The contrast rings 25 are intended to improve the visibility of the balloon 13 under X-ray projection and to facilitate the positioning of the balloon 13 at the target treatment site.

[0047] 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, the protrusion 30 can make an incision in the lesion, which can then be used 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 inflation state of the balloon 13.

[0048] As shown in FIG. 2, FIG. 3(a) and FIG. 3(b), the protrusion 30 is provided protruding from the outer surface 27 of the balloon 13 and extends 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 three protrusions 30 are arranged in this embodiment. Therefore, in this embodiment, the number of the protrusions 30 is the same as the number of the wing portions 21. The protrusions 30 are provided on the straight pipe portion 13c of the balloon 13, more specifically, only on the straight pipe 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 pipe portion 13c of the balloon 13.

[0049] 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 of, for example, 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 as to approach each other as they move away from the outer surface 27 of the balloon 13.

[0050] The upright portions 31 are joined (fixed) to each other by welding or adhesion at their tips in the upright direction (the ends on the side away from the outer surface 27). As a result, the upright portions 31 form a mountain-shaped protrusion 30. The joints of the upright portions 31 form the tops 33 of the protrusions 30, and the tops 33 can be used to make incisions in the affected area. A hollow portion 34 is formed between the upright portions 31, and the protrusions 30 are hollow protrusions. In this embodiment, the thickness of the upright portions 31 is smaller toward the tips of the upright portions 31, but the thickness of the upright portions 31 may be constant over the entire upright direction of the upright portions 31.

[0051] 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 to the tip end. In this case, the tips of each standing portion 31 are fixed to each other, and 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.

[0052] Each standing portion 31 is arranged so as to be able to tilt with respect to the outer surface 27 of the balloon 13 (see also FIG. 4(b)). Each standing portion 31 is also able to be folded along the apex 33. Here, in the present balloon catheter 10, when the balloon 13 is in a deflated state, 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 a deflated state will be described below with reference to FIGS. 4(a) and (b).

[0053] 4(a) and (b), when the balloon 13 is in a deflated 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 where it is 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 state where it is folded against each other. In this case, each standing portion 31A, 31B is folded so as to overlap in the radial direction of the balloon 13.

[0054] Of each of the upright portions 31, one upright portion 31A is fixed to the outer surface 27 of the wing portion 21 (more specifically, the overlapping portion 21a), and the other upright portion 31B is fixed to the outer surface 27 of the wing opposing portion 22. The upright portion 31A is inclined relative to the outer surface 27 of the wing portion 21 (overlapping portion 21a) and is disposed along the outer surface 27. The upright portion 31B is inclined relative to the outer surface 27 of the wing opposing portion 22 and is disposed along the outer surface 27. These inclined upright portions 31A and 31B are folded relative to each other. In the folded state of the upright portions 31A and 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.

[0055] Next, a method of using the balloon catheter 10 will be described. Here, a procedure for dilating a lesion occurring in a blood vessel using the balloon catheter 10 will be described.

[0056] 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.

[0057] 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 becoming large. This makes it possible to prevent a decrease in insertability when the balloon 13 is introduced toward the lesion.

[0058] 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)). More specifically, in this case, the expansion of the balloon 13 causes the wing portions 21 to unfold and the balloon 13 to become 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.

[0059] When the balloon 13 is inflated so that the upright portions 31 are in an upright state, the protrusions 30 are pressed against the lesion, and cuts (cracks) are made in the lesion by the protrusions 30. This allows the lesion to be expanded by destroying the lesion using the cuts as a trigger.

[0060] After the balloon 13 has completed dilating 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 FIGS. 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.

[0061] As described above, the balloon catheter 10 is primarily used by being passed through blood vessels to treat blood vessels such as the coronary arteries, femoral arteries, and pulmonary arteries. However, it can also be used in other "tubes" and "body cavities" within the body, such as the urinary tract and digestive tract, other than blood vessels.

[0062] According to the configuration of this embodiment described in detail above, the following excellent effects can be obtained.

[0063] When the balloon 13 is in a contracted state, each standing portion 31 is sandwiched between the blade portion 21 and the blade opposing portion 22 and is inclined. In this case, it is possible to prevent the outer diameter of the balloon 13 from increasing in the contracted state of the balloon 13. Therefore, it is possible to prevent a decrease in the insertability when the balloon 13 is inserted into the body in the contracted state.

[0064] In addition, since each standing portion 31 is sandwiched between the blade portion 21 and the blade opposing portion 22, it is easy to maintain the tilted state of each standing portion 31. Therefore, it is possible to preferably prevent the outer diameter of the balloon 13 from increasing, and as a result, it is possible to preferably prevent a decrease in insertability.

[0065] One of the standing portions 31, 31A, is fixed to the blade portion 21, and the other standing portion 31B is fixed to the blade opposing portion 22. In this case, when each standing portion 31 (31A, 31B) is sandwiched between the blade portion 21 and the blade opposing portion 22, the standing portion 31A is inclined with respect to the outer surface 27 of the blade portion 21, and the standing portion 31B is inclined with respect to the outer surface 27 of the blade opposing portion 22, so that the standing portions 31A, 31B can be easily arranged in a state where they overlap each other, that is, 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 the insertability.

[0066] Furthermore, 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 put into a folded (inclined) state, which makes it convenient for inserting the balloon 13 into the body while repeatedly expanding and contracting the balloon 13.

[0067] Second Embodiment Next, the second embodiment will be described. In this embodiment, the protruding portion 30 is provided with a connecting portion that connects the upright portions 31, and in this respect, the configuration is different from the first embodiment. Therefore, hereinafter, the configuration of this embodiment will be described with a focus on the difference. FIG. 5 is a cross-sectional view showing the periphery of the protruding portion 30 in this embodiment, where (a) shows the upright portions 31 in an upright state, and (b) shows the upright 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), the balloon 13 is simply shown in a state in which the upright portions 31 are folded between the wing portion 21 and the wing opposing portion 22 (these points are the same as in FIGS. 6(a) and (b) described later).

[0068] 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, more specifically, the approximate center portion, of each of the standing portions 31 in the standing direction. In this case, the connecting portion 40 prevents each of the standing portions 31 from opening in the direction away from each other.

[0069] According to the above configuration, when making an incision in the lesion with 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.

[0070] 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 opposite side to the apex 33 of the protruding portion 30.

[0071] In this configuration, when balloon 13 is contracted and each standing portion 31 is folded between blade portion 21 and blade opposing portion 22, connecting portion 40 is bent and deformed accordingly. This makes it possible to prevent connecting portion 40 from interfering with the folding of each standing portion 31. As a result, even in a configuration having connecting portion 40, it is possible to suitably prevent a decrease in the insertability of balloon 13.

[0072] The connecting portion 40 may be provided so as to connect the tip side of each standing portion 31 in the standing direction, or may be provided so as to connect the base end side. Also, a plurality of connecting portions 40 may be provided, in which case, the connecting portion 40 may be provided on each of the tip side and the 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 a plurality of linear connecting portions in the longitudinal direction of each standing portion 31.

[0073] Furthermore, the connecting portion 40 does not necessarily have 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. Furthermore, 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.

[0074] The connecting portion 40 does not necessarily need to be formed to be bendable and may be formed, for example, from a rubber material or the like to be stretchable in the connecting direction connecting each standing portion 31. In this case, when each standing portion 31 is folded between the blade portion 21 and the blade opposing portion 22, the connecting portion will shrink and deform accordingly. Therefore, even in this configuration, it is possible to prevent the connecting portion from interfering with the folding of each standing portion 31.

[0075] 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.

[0076] As shown in FIG. 6(a), the protruding portion 30 is provided with a support portion 50 extending across the top portion 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 protruding portion 30, and is disposed between each of the upright portions 31 of the protruding portion 30. The support portion 50 is fixed to the top portion 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 portion 33. The top portion 33 is supported by the support portion 50.

[0077] 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 part 50. Therefore, when the apex 33 makes an incision, the apex 33 can be suitably prevented from being crushed. This allows the incision to be made in the lesion in a more stable state.

[0078] In addition, since the support part 50 is fixed only to the top part 33, as shown in Fig. 6(b), when each standing part 31 is folded when the balloon 13 is deflated, the support part 50 moves away from the outer surface 27 of the balloon 13. This makes it possible to prevent the folding of each standing part 31 from being hindered by the support part 50. As a result, even in a configuration having the support part 50, it is possible to suitably prevent a decrease in insertability.

[0079] Note 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 a plurality of linear support portions in the longitudinal direction of the protruding portion 30.

[0080] [Fourth embodiment] Next, a fourth embodiment will be described. In this embodiment, a connection part for connecting each standing part 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 part 61 of the protrusion 60 in this embodiment, where (a) shows the state in which each standing part 31 is standing, and (b) shows the state in which each standing part 31 is folded. Note that the balloon 13 is omitted in FIGS. 7(a) and (b), but the balloon 13 is in an expanded state in FIG. 7(a) and in a contracted state in FIG. 7(b).

[0081] As shown in FIG. 7(a), the protruding portion 60 has, in addition to each of the standing portions 31, a pair of connecting portions 61 that connect each of the standing portions 31. The connecting portions 61 are disposed at both ends of the protruding portion 60 in the longitudinal direction, and connect the longitudinal ends of each of the standing portions 31 to each other. The connecting portions 61 are plate-shaped and are formed of, for example, a resin material. The connecting portions 61 extend in the direction in which each of the standing portions 31 stands up, 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.

[0082] 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 suitably prevent the protrusion 60 from being crushed due to the load.

[0083] Furthermore, the connection portion 61 has a fold 65 formed therein, which extends from the apex 63 of the protruding portion 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 the fold 65 so as to be convex outward in the longitudinal direction of the protruding portion 60. This allows the connection portion 61 to stably support the load acting on the protruding portion 60.

[0084] Moreover, the connection portion 61 is foldable along the crease 65. In this case, the connection portion 61 is foldable 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 is capable of being 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.

[0085] In addition, since the connection parts 61 are not fixed to the outer surface 27 of the balloon 13, the connection parts 61 are easily folded and deformed in accordance with the folding of the standing parts 31. Therefore, when the standing parts 31 are folded, it is possible to further suppress the folding being hindered by the connection parts 61.

[0086] Instead of or in addition to arranging the connection part 61 at the longitudinal end part of the protrusion 60, the connection part 61 may be arranged at the longitudinal middle part of the protrusion 60. The number of the connection parts 61 may be three or more, or may be one. The connection part 61 may be fixed to the outer surface 27 of the balloon 13.

[0087] [Other embodiments] The present disclosure is not limited to the above embodiment, and may be implemented, for example, as follows.

[0088] (1) In the first embodiment, one of the standing portions 31 is fixed to the blade portion 21 and the other is fixed to the blade 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 blade 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 the standing state of the standing portions 31 when the balloon 13 is inflated, for reference.

[0089] In the above configuration, when the balloon 13 is in a contracted state, the standing portions 31 face each other across the wing portion 21 (the overlapping portions 21a, 21b), thereby being in a tilted state. More specifically, 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.

[0090] (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 protrusions 71 rise so as to approach each other as they move away from the outer surface 27 as a whole. The protrusions 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 the joining. As a result, even in the protrusion 70, the apex 75 can make an incision in the lesion.

[0091] Furthermore, each standing portion 71 is capable of tilting 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 blade portion 21 and the blade opposing portion 22, and is tilted in a mutually folded state. This makes it possible to suitably suppress an increase in the outer diameter of the balloon 13 by the protruding portion 70 as well.

[0092] (3) Figures 10(a) to (c) show another embodiment of the protruding portion 80. As shown in Figures 10(a) and (b), the protruding portion 80 has a pair of standing portions 81 standing in parallel to each other, and a pair of connecting portions 82 connecting the standing portions 81. Each connecting portion 82 is disposed at both ends of the pair of standing portions 81 in the longitudinal direction, and connects the ends of the standing portions 81 to each other. Each connecting portion 82 extends in the standing direction of each standing portion 81, and is provided in a state of contact with the outer surface 27 of the balloon 13. As a result, according to the protruding portion 80 of this example, the load acting on the protruding portion 80 from the diseased area side can be applied to each standing portion 81 and also supported by the connecting portion 82.

[0093] The connecting portion 82 is folded along a crease 85 extending in the direction in which the upright portion 81 stands, thereby forming a mountain shape that is convex outward in the longitudinal direction of the protruding portion 80. The connecting portion 82 is also foldable along the crease 85. As a result, as shown in FIG. 10(c), when the upright portions 81 are sandwiched between the vane portion 21 and the vane opposing portion 22 as the balloon 13 contracts, the upright portions 81 approach each other and overlap, and the connecting portion 82 is folded and deformed 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 connecting portion 82, it is possible to suitably suppress a decrease in insertability.

[0094] (4) Figures 11(a) to (c) show another embodiment of the protruding portion 90. As shown in Figure 11(a), the protruding portion 90 has a pair of standing portions 91 and a bridge portion 92 that bridges the tip portions of each standing portion 91. As shown in Figures 11(b) and (c), when each standing portion 91 is inclined with respect to the outer surface 27 of the balloon 13, the protruding portion 90 is inclined as a whole. Therefore, such a protruding portion 90 can also suppress the outer diameter of the balloon 13 from increasing, and as a result, the deterioration of the insertability can be suitably suppressed. Note that a bridge portion may also be bridged over the base end portion of each standing portion 91.

[0095] (5) In 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.

[0096] (6) In each of the above embodiments, the protruding portion 30 is formed by joining the upright portions 31 to each other, but for example, the protruding portion 30 may be formed 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.

[0097] (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 in the axial direction of the balloon 13 and provided as a plurality of protrusions.

[0098] (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.

[0099] (9) The protrusion 30 may be made of a material other than a resin material, such as a hard polymer or a metal material.

[0100] (10) In each of the above embodiments, each of the wing portions 21 is folded so as to be convex on one circumferential side (i.e., the same side) of the balloon 13. However, 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.

[0101] (11) The protrusions include protrusions for applying a drug to a lesion, protrusions for preventing the balloon 13 from slipping, and the like, in addition to the protrusions 30 for making an incision in the lesion. Therefore, the present disclosure may be applied to these protrusions.

[0102] Although the present disclosure has been described based on the 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 equivalent range. 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 concept of the present disclosure. [Explanation of symbols]

[0103] Reference Signs List 10: balloon catheter, 13: balloon, 21: wing portion, 22: wing opposing portion, 27: outer surface, 30: protrusion, 31: upright portion, 33: top portion, 40: connecting portion, 50: support portion, 61: connection portion.

Claims

1. 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.

2. 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.

3. 3. The balloon catheter according to claim 2, wherein one of the upright portions is fixed to the wing portion and the other is fixed to the wing opposing portion.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. The balloon catheter of claim 9 , wherein the connection portion is non-fixed relative to the outer surface.

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