Balloon catheter

Abstract

A balloon catheter according to the present invention includes: a shaft extending in an extension direction across a first distal end (2D) and a first proximal end; and a balloon body (30A) and a transducer (5A) provided to the shaft. The balloon body (30A) includes a balloon (30) and elements (41, 42, 43). The balloon (30) is configured so as to expand radially relative to a central axis (C) of the shaft, and covers the vicinity of the first distal end (2D) of the shaft. The elements (41, 42, 43) are entirely fixed to at least a portion of the balloon (30). The transducer (5A) is capable of continuously vibrating by converting electrical energy into vibrational energy. The transducer (5A) causes the balloon body (30A) to vibrate.

Description

Balloon catheter

[0001] The present invention relates to a balloon catheter.

[0002] Patent Document 1 discloses a shock wave catheter. The shock wave catheter has a conductive sheath inside a balloon. Also, an electrode formed at the tip of a wire is disposed at a position adjacent to the conductive sheath. A high voltage is applied to the wire by a high voltage pulse generator connected to the base end of the wire. At this time, an arc discharge occurs between the conductive sheath and the electrode, generating a plasma arc. The plasma arc generates bubbles in the surrounding liquid. Due to the rapid expansion and collapse of these bubbles, a shock wave is generated. The balloon receives the stress from the shock wave and moves instantaneously. For example, when a shock wave is generated in a state where the balloon is in close contact with a calcified plaque in a blood vessel, the balloon pulverizes the calcified plaque by instantaneous movement. [[ID=??]]

[0003] Japanese Patent Translation of PCT International Publication No. 2021-503344

[0004] In the instantaneous movement of the balloon, the therapeutic effect on the lesion of the blood vessel may be limited. Therefore, a balloon catheter with a higher therapeutic effect is desired.

[0005] An object of the present invention is to provide a balloon catheter capable of improving the therapeutic effect on a lesion by appropriately applying the force of continuous vibration to the lesion of a blood vessel.

[0006] The balloon catheter according to the present invention includes a shaft extending in the extending direction between a first tip and a first base end, and a balloon body provided on the shaft, the balloon body being configured to expand radially with respect to the central axis of the shaft and covering the vicinity of the first tip of the shaft, and an element entirely fixed to at least a part of the balloon, and is characterized by including a converter that can convert electrical energy into vibration energy and vibrate continuously.

[0007] For example, if the converter continuously vibrates the balloon body, the balloon catheter can appropriately treat vascular lesions with the continuously vibrating balloon body. Therefore, by appropriately applying the force of continuous vibration to the vascular lesion, the balloon catheter can improve the therapeutic effect on the lesion.

[0008] In the present invention, the converter may continuously vibrate the element. In this case, the balloon catheter can appropriately treat the lesion with the vibrating element.

[0009] In the present invention, the element may be integrally molded with the balloon. In this case, the balloon catheter can prevent the element from detaching from the balloon due to vibration of the balloon body.

[0010] In the present invention, the converter may be provided inside the balloon in the radial direction with respect to the central axis. In this case, the balloon catheter can maintain a smaller balloon diameter compared to the case where the converter is provided outside the balloon. Therefore, the balloon catheter can improve the passage of the balloon body through blood vessels.

[0011] In the present invention, the converter may be provided on the portion of the shaft located inside the balloon in the radial direction. In this case, the balloon catheter can stabilize the position of the converter.

[0012] In the present invention, the converter may be provided on the balloon body. In this case, the balloon catheter can be efficiently vibrated by the converter.

[0013] In the present invention, the converter may be provided on the element. In this case, the balloon catheter can vibrate the element with maximum efficiency by the converter.

[0014] In the present invention, the transformer may be provided in the circumferential direction around the central axis. In this case, even if the multiple elements are distributed circumferentially around the balloon, the multiple elements can be vibrated.

[0015] In the present invention, the converters may be arranged at equal intervals in the circumferential direction. In this case, the balloon catheter can vibrate a plurality of elements that are dispersed in the circumferential direction uniformly.

[0016] In the present invention, the balloon extends from a second tip to a second base, the distance in the extension direction between the first tip and the second tip is smaller than the distance in the extension direction between the first tip and the second base, the balloon has a tip leg portion, a tip tapered portion, a central portion, a base tapered portion, and a base leg portion, the central portion has a cylindrical shape extending in the extension direction, the tip tapered portion extends from a third tip adjacent to the second tip of the central portion toward the opposite direction from the central portion while decreasing in diameter, and the tip leg The leg portion extends from the end of the tip tapered portion adjacent to the second tip to the second tip and connects to the shaft; the base tapered portion extends from the end of the central portion adjacent to the second base end toward the opposite side of the central portion, while decreasing in diameter; the base leg portion extends from the end of the base tapered portion adjacent to the second base end to the second base end and connects to the shaft; and in the extension direction, the position of at least a part of the transformer may coincide with the position of at least a part of the central portion. The transformer may vibrate the balloon body via the fluid by vibrating the fluid filled inside the balloon when the balloon is inflated. Here, by positioning the transformer such that the position of at least a part of the transformer coincides with the position of at least a part of the central portion in the extension direction, the vibration of the transformer can be efficiently transmitted from the transformer to the entire balloon body in the extension direction. Therefore, the balloon catheter can treat lesions by efficiently vibrating the entire balloon body with the transformer.

[0017] In the present invention, the balloon extends from a second tip to a second base, the distance in the extension direction between the first tip and the second tip is smaller than the distance in the extension direction between the first tip and the second base, the balloon has a tip leg portion, a tip tapered portion, a central portion, a base tapered portion, and a base leg portion, the central portion has a cylindrical shape extending in the extension direction, the tip tapered portion extends from a third tip adjacent to the second tip of the central portion toward the opposite direction from the central portion while decreasing in diameter, and the tip leg portion is The tip tapered portion extends from the end adjacent to the second tip to the second tip and connects to the shaft, the base tapered portion extends from the end adjacent to the second base of the central portion toward the opposite side of the central portion while decreasing in diameter, the base leg portion extends from the end adjacent to the second base of the base tapered portion to the second base and connects to the shaft, and in the extension direction, the position of at least a part of the transformer body may coincide with at least a part of the position between the first tip and the third tip. For example, the balloon catheter may vibrate the transformer body with the vicinity of the first tip inserted into a lesion with a small lumen diameter. In this case, the balloon catheter can treat the lesion by vibrating the balloon body even when the balloon is not fully inflated.

[0018] In the present invention, in the extension direction, the position of at least a portion of the transformer may coincide with at least a portion of the position between the first tip and the second tip. In this case, the transformer is positioned closer to the first tip of the shaft. Therefore, the balloon catheter can efficiently treat lesions with a small lumen diameter by vibrating the transformer while the vicinity of the first tip is inserted into the lesion.

[0019] In the present invention, the balloon extends from a second tip to a second base, the distance in the extension direction between the first tip and the second tip is smaller than the distance in the extension direction between the first tip and the second base, the balloon has a tip leg portion, a tip tapered portion, a central portion, a base tapered portion, and a base leg portion, the central portion has a cylindrical shape extending in the extension direction, the tip tapered portion extends from a third tip adjacent to the second tip of the central portion toward the opposite direction from the central portion while decreasing in diameter, and the tip leg portion is The tip tapered portion extends from the end adjacent to the second tip to the second tip and connects to the shaft, the base tapered portion extends from the end adjacent to the second base in the central portion toward the opposite side of the central portion while decreasing in diameter, and the base leg portion extends from the end adjacent to the second base in the base tapered portion to the second base and connects to the shaft, and in the extension direction, the position of at least a part of the transformer does not have to coincide with the position of at least a part between the first tip and the third tip. In this case, the balloon catheter can maintain flexibility in the portion between the first tip and the third tip. Therefore, the balloon catheter can maintain good balloon passage through blood vessels.

[0020] In the present invention, the converter may vibrate continuously at a frequency of 1 MHz to 10 MHz. In this case, the balloon catheter can enhance the therapeutic effect of the vibration of the balloon body on lesions.

[0021] In the present invention, the converter may vibrate continuously at a frequency of 2 MHz to 3 MHz. In this case, the balloon catheter can further enhance the therapeutic effect of the vibration of the balloon body on the lesion.

[0022] In the present invention, the converter may include a piezoelectric element. The piezoelectric element can efficiently convert electrical energy into vibrational energy, thereby causing the balloon body to vibrate continuously.

[0023] In the present invention, the element may contain a drug. By vibrating the element, the balloon catheter can efficiently penetrate the drug contained in the element into the lesion.

[0024] This is a side view of balloon catheter 1. This is a cross-sectional view of balloon body 30A. This is a cross-sectional view of balloon body 30B. This is a cross-sectional view of balloon body 30C. This is a cross-sectional view of balloon body 30D. This is a cross-sectional view of balloon body 30E. This is a cross-sectional view of balloon body 30F.

[0025] Embodiments of the present invention will be described with reference to the drawings. The drawings are used to illustrate the technical features that the present invention may adopt. The configurations of the devices described are not intended to limit the invention to those described, but are merely illustrative examples.

[0026] <Overview of Balloon Catheter 1> Balloon Catheter 1 (1A-1F) is a medical device used to treat lesions in blood vessels and arteries. Balloon Catheter 1 is particularly suitable for use in creating cracks in plaque and calcified lesions to expand them, or for fragmenting lesions. Balloon Catheter 1 allows for highly accurate treatment while minimizing the burden on the patient.

[0027] As shown in Figure 1, the balloon catheter 1 includes a shaft 2, balloon bodies 3 (30A to 30F), converters 5 (5A to 5F) (see Figure 2, etc.), a hub 8, and an AC power supply 9.

[0028] The shaft 2 is tubular and extends along the extension direction D. One end of the shaft 2 in the extension direction D is called the "first tip 2D". The other end of the shaft 2 in the extension direction D is called the "first base end 2P". A hypothetical axis that passes through the center of the shaft 2 and extends along the extension direction D is called the "central axis C". The radial direction around the central axis C is simply called the "radial direction". In the radial direction, the direction approaching the central axis C is called the "inward direction", and the direction moving away from the central axis C is called the "outward direction". The circumferential direction around the central axis C is simply called the "circumferential direction". The cross-section obtained when the shaft is cut by a hypothetical plane perpendicular to the central axis C is simply called the "cross-section".

[0029] The balloon body 3 is connected near the first tip 2D of the shaft 2. The hub 8 and AC power supply 9 are connected near the first base end 2P of the shaft 2. Details of the balloon body 3 will be described later.

[0030] As shown in Figure 2, the shaft 2 has an outer tube 21, an inner tube 22, and a tip 23.

[0031] The outer tube 21 and the inner tube 22 each have a lumen and are flexible. The material of the outer tube 21 and the inner tube 22 is not particularly limited, but a polyamide resin is used as an example.

[0032] The outer tube 21 extends along the extension direction D between its tip 211 and base 212 (see Figure 1). The inner tube 22 extends along the extension direction D between its tip 221 and base 222 (see Figure 1). The base 212 of the outer tube 21 and the base 222 of the inner tube 22 correspond to the first base 2P of the shaft 2.

[0033] The inner diameter of the cross-section of the outer tube 21 is larger than the outer diameter of the cross-section of the inner tube 22. The inner tube 22 is positioned inside the outer tube 21, except for a predetermined portion near the tip 221. The predetermined portion of the inner tube 22 protrudes from the tip 211 of the outer tube 21. The predetermined portion of the inner tube 22 is called the "protruding portion 225".

[0034] When the balloon catheter 1 is introduced into the body, a guidewire (not shown) is inserted into the lumen of the inner tube 22.

[0035] A tip 23 is connected to the tip 221 of the inner tube 22. The tip 23 is cylindrical and extends along the extension direction D. A through-hole for inserting a guidewire is provided in the portion of the tip 23 that overlaps with the central axis C. The tip 23 prevents damage to blood vessels and tissues when the balloon catheter 1 is inserted into the body.

[0036] The material of the tip 23 is not particularly limited, but polyurethane or silicone can be used as examples. Of the tip 23, the end opposite to the end connected to the tip 221 of the inner tube 22 corresponds to the first tip 2D of the shaft 2.

[0037] As shown in Figure 1, the hub 8 connected to the first base end 2P of the shaft 2 can supply fluid to the space within the lumen of the outer tube 21, excluding the lumen of the inner tube 22.

[0038] An AC power supply 9 connected to the first base end 2P of the shaft 2 applies an AC voltage having a continuously changing sinusoidal shape to the converter 5. The AC power supply 9 and the converter 5 are connected by a conductor. The frequency band of the AC voltage includes the frequency band of ultrasound. More specifically, the frequency of the AC voltage is in the range of 1 MHz to 10 MHz. More preferably, the frequency of the AC voltage is in the range of 2 MHz to 3 MHz.

[0039] The location where the converter 5 is provided differs for each of the converters 5A to 5F. The converter 5 converts the electrical energy of the AC voltage applied by the AC power supply 9 into vibrational energy, and vibrates continuously due to the vibrational energy. Details of the converter 5 will be described later.

[0040] Furthermore, the balloon catheter 1 is not equipped with a receiving unit to receive ultrasound waves generated by the vibration of the converter 5.

[0041] <First Embodiment (Balloon Catheter 1A)> The balloon catheter 1A according to the first embodiment has a balloon body 30A as the balloon body 3.

[0042] <Balloon body 30A> As shown in Figure 2, the balloon body 30A has a balloon 30 and a plurality of elements 4 (elements 41, 42, 43).

[0043] The balloon 30 is formed by a long, tubular membrane portion 300 along the stretching direction D. The balloon 30 extends in the stretching direction D between the second tip 3D and the second base end 3P. The second tip 3D is the end of the balloon 30 that is close to the first tip 2D in the stretching direction D. The second base end 3P is the end of the balloon 30 that is close to the first base end 2P in the stretching direction D. The distance between the first tip 2D and the second tip 3D in the stretching direction D is smaller than the distance between the first tip 2D and the second base end 3P in the stretching direction D.

[0044] The balloon 30 can be deformed between a contracted state and an inflated state by a change in internal pressure according to the presence or absence of fluid supply by the hub 8. The balloon 30 expands radially from the central axis C in response to the supply of fluid and the increase in internal pressure, and thus transforms from the contracted state to the inflated state. FIGS. 1 and 2 show the balloon 30 in the inflated state. The cross-sectional shape of the balloon 30 is substantially circular in the inflated state.

[0045] The balloon 30 has a tip leg portion 31, a tip tapered portion 32, a central portion 33, a base tapered portion 34, and a base leg portion 35. The tip leg portion 31, the tip tapered portion 32, the central portion 33, the base tapered portion 34, and the base leg portion 35 correspond to the respective parts obtained by dividing the balloon 30 into five along the extending direction D.

[0046] The length of the central portion 33 in the extending direction D is longer than the lengths of the tip leg portion 31, the tip tapered portion 32, the base tapered portion 34, and the base leg portion 35 in the extending direction D respectively.

[0047] The central portion 33 has a cylindrical shape extending in the extending direction D. The outer diameter and the inner diameter of the cross-section of the central portion 33 are substantially the same over the extending direction D when the balloon 30 is in the inflated state. Among the central portion 33, the end portion close to the second tip 3D of the balloon 30 is referred to as the "third tip 33D". Among the central portion 33, the end portion close to the second base end 3P of the balloon 30 is referred to as the "third base end 33P". The central position in the extending direction D of the central portion 33 is referred to as the "central position M".

[0048] The tip tapered portion 32 is connected to the third tip 33D of the central portion 33 and extends while reducing the diameter toward the opposite side of the central portion 33. The tip leg portion 31 is connected to the end portion of the tip tapered portion 32 opposite to the end portion connected to the central portion 33 and extends in the opposite direction to the tip tapered portion 32. The tip leg portion 31 is connected to the inner tube 22 by heat welding.

[0049] The end portion of the tip leg portion 31 opposite to the end portion connected to the tip tapered portion 32 corresponds to the second tip 3D of the balloon 30. The tip leg portion 31 extends between the end portion connected to the tip tapered portion 32 and the second tip 3D. The second tip 3D is disposed in the vicinity of the tip 221 of the inner tube 22.

[0050] The base tapered portion 34 is connected to the third base end 33P of the central portion 33 and extends in the opposite direction from the central portion 33 while decreasing in diameter. The base leg portion 35 is connected to the end of the base tapered portion 34 opposite to the end connected to the central portion 33 and extends in the opposite direction from the base tapered portion 34. The base leg portion 35 is connected to the outer tube 21 by heat welding.

[0051] The end of the base leg portion 35 opposite to the end connected to the base tapered portion 34 corresponds to the second base end 3P of the balloon 30. The base leg portion 35 extends between the end connected to the base tapered portion 34 and the second base end 3P.

[0052] The tip leg portion 31, the tip tapered portion 32, the central portion 33, and the base tapered portion 34 cover the protruding portion 225 of the inner tube 22 from the outside.

[0053] Multiple elements 4 are provided on the outer surface of the membrane portion 300 of the balloon 30. Each of the multiple elements 4 extends along the stretching direction D between the second tip 3D and the second base end 3P of the balloon 30.

[0054] The multiple elements 4 are integrally molded with the membrane portion 300 of the balloon 30 and are made of the same material as the membrane portion 300. The multiple elements 4 are fixed as a whole to the membrane portion 300. There are no joints between the multiple elements 4 and the membrane portion 300. For example, the membrane portion 300 and the multiple elements 4 are formed simultaneously by injection molding or blow molding.

[0055] The multiple elements 4 are harder than the film portion 300. For example, the multiple elements 4 may be hardened by localized irradiation with ultraviolet light or by localized heating.

[0056] In Figure 2, for ease of understanding, dotted lines are shown indicating boundaries between the membrane portion 300 of the balloon 30 and the multiple elements 4. In the following, unless otherwise specified, the multiple elements 4 will be described assuming the balloon 30 is in an inflated state.

[0057] Multiple elements 4 protrude outward from the outer surface of the film portion 300. The multiple elements 4 include elements 41, 42, and 43. Elements 41, 42, and 43 are each arranged at equal intervals in the circumferential direction on the outer surface of the film portion 300.

[0058] Of the multiple elements 4, the portion fixed to the central part 33 of the balloon 30 has the shape of a triangular prism, and its cross-sectional shape is triangular. Of the multiple elements 4, the portion provided in the central part 33 of the balloon 30 has a tip portion 40P, which is the radially outward end. The tip portion 40P is pointed.

[0059] Of the multiple elements 4, the shape of the portion fixed to the tip leg portion 31, tip tapered portion 32, base tapered portion 34, and base leg portion 35 of the balloon 30 is a rectangular prism, and the cross-sectional shape is trapezoidal.

[0060] <Converter 5A> Converter 5A is a piezoelectric element that is driven by the inverse piezoelectric effect. Converter 5A contains a piezoelectric material. The piezoelectric material has the characteristic of deforming when a voltage is applied. The piezoelectric material repeatedly expands and contracts and vibrates continuously when a continuous AC voltage is applied by the AC power supply 9.

[0061] The materials used for piezoelectric elements are not particularly limited, but specific examples include PZT (lead zirconate titanate), barium titanate, KNN (sodium potassium niobate), polyvinylidene fluoride, ammonium phosphate, and lead-free ceramics.

[0062] The converter 5A is provided on the outer surface of the protruding portion 225 of the inner tube 22. The converter 5A is provided continuously over the entire circumferential area of ​​the outer surface of the inner tube 22.

[0063] Furthermore, since the protruding portion 225 is covered from the outside by the balloon 30, the converter 5A is located inside the balloon 30 in the radial direction. More specifically, the converter 5A is located inside the central portion 33 of the balloon 30 in the radial direction. The length of the converter 5A in the extension direction D is shorter than the length of the central portion 33 of the balloon 30 in the extension direction D.

[0064] In the stretching direction D, the central position of the transformer 5A in the stretching direction D coincides with the central position M of the central part 33 of the balloon 30. In the stretching direction D, the position of the transformer 5A coincides with a portion of the central part 33 of the balloon 30, including the central position M.

[0065] Wires extending from the AC power supply 9 are connected to the converter 5A. The arrangement of the wires is not particularly limited, but as an example, the wires are fixed to the outer surface of the inner tube 22.

[0066] <Example of use> A guidewire is inserted into the patient's blood vessel. Next, an introducer sheath is inserted through the guidewire. A balloon catheter 1A is prepared with balloon 30 in a deflated state.

[0067] The balloon catheter 1A is inserted into the body along the guidewire. The balloon body 30A of the balloon catheter 1A moves toward the vascular lesion (for example, a narrowed or embolic area of ​​the blood vessel). Whether or not the balloon 30 has reached the lesion is confirmed by imaging diagnosis, for example, by confirming the position of an X-ray opaque marker (not shown) provided on the balloon body 30A or the protruding portion 225 of the shaft 2.

[0068] When the balloon body 30A reaches the lesion, fluid is supplied from the hub 8. The inside of the balloon 30 is filled with fluid, and the balloon 30 changes from a deflated state to an inflated state. This treats the lesion. For example, a narrowed area of ​​a blood vessel is expanded by the balloon 30. Also, as the balloon 30 changes to an inflated state, multiple elements 4 enter the lesion. This causes incision or pulverization of the lesion. Furthermore, displacement of the balloon 30 relative to the lesion is prevented.

[0069] The AC power supply 9 initiates the application of a continuous AC voltage to the converter 5A. The converter 5A vibrates continuously inside the balloon 30. The vibration frequency is the same as the frequency of the AC voltage. The vibration of the converter 5A is transmitted to the balloon body 30A by the fluid filled inside the balloon 30. As a result, the membrane portion 300 and the multiple elements 4 of the balloon 30 vibrate continuously.

[0070] In particular, the continuous vibration of multiple elements 4 allows for efficient incision and pulverization of lesions.

[0071] After a certain period of time, the application of AC voltage to the converter 5A by the AC power supply 9 is stopped. Next, fluid is discharged from the balloon 30, and the balloon 30 changes from an inflated state to a deflated state. In this state, the balloon catheter 1A is removed. The guide wire and introducer sheath are also removed if necessary.

[0072] <Operation and Effects of the First Embodiment> The balloon catheter 1A continuously vibrates the balloon body 30A using the converter 5A. In this case, the balloon catheter 1A can appropriately treat lesions with the membrane portion 300 and multiple elements 4 of the continuously vibrating balloon 30. Therefore, the balloon catheter 1A can achieve a good therapeutic effect on lesions.

[0073] Furthermore, when treating a lesion, if the internal pressure of the balloon 30 is increased and the balloon 30 is inflated, the stress acting on the blood vessel increases, which may lead to malignant dissection. In contrast, the balloon catheter 1A can treat lesions even under conditions where the internal pressure of the balloon 30 is relatively low. In this case, the stress on the blood vessel can be reduced, and therefore the balloon catheter 1A can prevent the occurrence of malignant dissection.

[0074] Conventional methods attempt to treat vascular lesions by instantaneously moving a balloon using shock waves. However, this increases the likelihood of the balloon's force acting on an unexpected location in the blood vessel, making it difficult to accurately apply force to the lesion. On the other hand, the balloon catheter 1A allows the balloon body 30A to be continuously vibrated, enabling treatment by appropriately applying force from the balloon body 30A to the lesion.

[0075] The balloon catheter 1A vibrates multiple elements 4 continuously through the vibration of the converter 5A. The multiple vibrating elements 4 of the balloon catheter 1A allow for efficient incision and pulverization of hardened lesions. Therefore, the balloon catheter 1A can effectively treat lesions.

[0076] Multiple elements 4 are fixed to the membrane portion 300 of the balloon 30. This prevents the balloon catheter 1A from moving relative to and rubbing against parts of the multiple elements 4 and the balloon 30, thus preventing damage to the balloon 30 due to friction between the multiple elements 4 and the balloon 30. Furthermore, the balloon catheter 1A prevents the multiple elements 4 from shifting relative to the balloon 30, allowing the balloon 30 to be inflated while maintaining the arrangement (circumferential spacing) of the multiple elements 4 across the entire area of ​​the multiple elements 4. In addition, the balloon catheter 1A prevents the multiple elements 4 from rotating and tipping over, allowing the pointed tip 40P of the multiple elements 4 to contact the lesion and perform treatment across the entire area of ​​the multiple elements 4.

[0077] Multiple elements 4 are integrally molded with the membrane portion 300 of the balloon 30. Therefore, the balloon catheter 1A can prevent the multiple elements 4 from detaching from the balloon 30 due to vibration of the balloon body 30A.

[0078] The converter 5A is located radially inside the balloon 30. In this case, the balloon catheter 1A can maintain a smaller diameter of the balloon 30 in its deflated state compared to the case where the converter 5A is provided on the outer surface of the balloon 30. Therefore, the balloon catheter 1A can improve the passage of the balloon body 30A through the blood vessel.

[0079] Furthermore, since the converter 5A vibrates inside the balloon 30 located near the first tip 2D of the shaft 2, vibrations are less likely to be transmitted to the first proximal end 2P of the shaft 2. In this case, the balloon catheter 1A can suppress the reduction in operability caused by vibrations at the operator's hand due to the converter 5A.

[0080] Furthermore, if the converter 5A is provided near the first proximal end 2P of the shaft 2, the vibration force is attenuated as it is transmitted to the balloon body 30A. In contrast, the balloon catheter 1A vibrates the converter 5A inside the balloon 30, so the vibration force in the converter 5A can be efficiently transmitted to the balloon body 30A.

[0081] The converter 5A is provided on the portion of the inner tube 22 that is located radially inside the balloon 30, i.e., on the protruding portion 225 of the inner tube 22. In this case, the balloon catheter 1A can stabilize the position of the converter 5A.

[0082] Furthermore, the protruding portion 225 of the shaft 2 is located at the radial center of the inflated balloon 30. Therefore, by providing the converter 5A on the protruding portion 225 of the shaft 2, the radial distance between the balloon 30 and the multiple elements 4 of the balloon body 3 and the converter 5A can be made uniform. Consequently, the balloon catheter 1A can make the balloon 30 and the multiple elements 4 of the balloon body 30A vibrate uniformly.

[0083] Furthermore, compared to the case where the converter 5A is provided on the inner surface of the balloon 30, the flexibility of the balloon 30 can be maintained.

[0084] In the inflated balloon 30, the converter 5A vibrates the fluid filled inside the balloon 30, thereby vibrating the balloon body 30A through the fluid. Here, in the stretching direction D, the position of the converter 5A coincides with the position of a part of the central portion 33 of the balloon 30. In this case, the vibration of the converter 5A is transmitted from the converter 5A to the entire balloon body 30A in the stretching direction D. Therefore, the balloon catheter 1A can efficiently vibrate the entire balloon body 30A with the converter 5A to treat lesions.

[0085] The vibration frequency of the converter 5A is the same as the frequency of the applied AC voltage. Therefore, the converter 5A vibrates more preferably in the range of 1 MHz to 10 MHz, and even more preferably in the range of 2 MHz to 3 MHz. When multiple elements 4 vibrate at these frequencies, the vibration energy can be concentrated in a narrower range compared to when multiple elements 4 vibrate at other frequencies. Therefore, the balloon catheter 1A can particularly enhance the therapeutic effect of lesions caused by the vibration of multiple elements 4.

[0086] The converter 5A includes a piezoelectric element. This allows the converter 5A to efficiently convert electrical energy into vibrational energy using the piezoelectric element, thereby vibrating the balloon body 30A.

[0087] <Second Embodiment (Balloon Catheter 1B)> The balloon catheter 1B according to the second embodiment has a balloon body 30B as the balloon body 3. The balloon body 30B differs from the balloon body 30A in that it has a converter 5B instead of the converter 5A.

[0088] As shown in Figure 3, the converter 5B is provided on the outer surface of the protruding portion 225 of the inner tube 22. The converter 5B is provided continuously over the entire circumferential area of ​​the outer surface of the inner tube 22.

[0089] The transformer 5B is located in the extension direction D between the first tip 2D of the shaft 2 and the third tip 33D of the central portion 33 of the balloon 30. More specifically, the transformer 5B is located radially inside the tip leg portion 31 of the balloon 30.

[0090] The length of the transformer 5B in the extension direction D is shorter than the length of the tip leg portion 31 in the extension direction D. The end of the transformer 5B that is close to the first tip 2D is located closer to the first base end 2P than to the second tip 3D of the balloon 30. The end of the transformer 5B that is close to the first base end 2P is located closer to the first tip 2D than to the end of the tip leg portion 31 of the balloon 30 that connects to the tip tapered portion 32.

[0091] <Operation and Effects of the Second Embodiment> In the balloon catheter 1B, the converter 5B is closer to the first tip 2D of the shaft 2 compared to the balloon catheter 1A. Therefore, the converter 5B can efficiently vibrate the portion of the balloon body 30B that is particularly close to the first tip 2D. In addition, the converter 5B can vibrate the tip 23 in addition to the balloon body 30B.

[0092] For example, with the balloon catheter 1B inserted near the first tip 2D into a small lesion in its lumen, the portion of the balloon body 30B adjacent to the first tip 2D can be vibrated. In this case, even if the balloon 30 is not fully inflated, the balloon body 30B can be vibrated to treat the lesion.

[0093] Furthermore, multiple elements 4 are also arranged on the tip leg portion 31 of the balloon 30. Therefore, the converter 5B can efficiently treat lesions by vibrating the portion of the multiple elements 4 that is provided on the tip leg portion 31.

[0094] <Third Embodiment (Balloon Catheter 1C)> The balloon catheter 1C according to the third embodiment has a balloon body 30C as the balloon body 3. The balloon body 30C differs from the balloon bodies 30A and 30B in that it has a converter 5C instead of converters 5A and 5B.

[0095] As shown in Figure 4, the converter 5C is provided inside the chip 23. The converter 5C has a cylindrical shape and is provided continuously in the circumferential direction. The converter 5C covers the area around the through hole of the chip 23.

[0096] The transformer 5C is located between the first tip 2D of the shaft 2 and the second tip 3D of the balloon 30 in the stretching direction D. The length of the transformer 5C in the stretching direction D is shorter than the length of the tip 23 in the stretching direction D.

[0097] <Operation and Effects of the Third Embodiment> Compared to the converters 5A and 5B, the converter 5C is positioned closer to the first tip 2D of the shaft 2. For example, with the balloon catheter 1C, the tip 23 can be vibrated by the converter 5C while the tip 23 is inserted into a lesion with a small lumen. In this case, the balloon catheter 1C can efficiently treat lesions with a small lumen diameter.

[0098] Furthermore, the converter 5C can directly vibrate the tip 23. In this case, the balloon catheter 1C can treat lesions by vibrating the tip 23.

[0099] <Fourth Embodiment (Balloon Catheter 1D)> The balloon catheter 1D according to the fourth embodiment has a balloon body 30D as the balloon body 3. The balloon body 30D differs from the balloon bodies 30A to 30C in that it has a converter 5D instead of converters 5A to 5C.

[0100] As shown in Figure 5, the converter 5D is provided on the outer surface of the protruding portion 225 of the inner tube 22. The converter 5D is provided continuously over the entire circumferential area of ​​the outer surface of the inner tube 22.

[0101] The transformer 5D is located in the extension direction D between the first base end 2P of the shaft 2 and the third base end 33P of the central portion 33 of the balloon 30. More specifically, the transformer 5D is located radially inside the base end tapered portion 34 of the balloon 30.

[0102] The length of the transformer 5D in the extension direction D is shorter than the length of the base tapered portion 34 in the extension direction D. The end of the transformer 5D that is close to the first tip 2D is located closer to the first base end 2P than to the third base end 33P of the balloon 30. The end of the transformer 5D that is close to the first base end 2P is located closer to the first tip 2D than to the end of the base tapered portion 34 of the balloon 30 that connects to the base leg portion 35.

[0103] Unlike balloon bodies 30B and 30C, the transformer 5D is not positioned between the first tip 2D of the shaft 2 and the third tip 33D of the central portion 33 of the balloon 30 in the extension direction D. Also, unlike balloon body 30A, the transformer 5D is not positioned in a location that includes the central position M of the central portion 33 in the extension direction D. Also, unlike balloon bodies 30A to 30C, the transformer 5D is not positioned between the first tip 2D of the shaft 2 and the third base end 33P of the central portion 33 of the balloon 30 in the extension direction D.

[0104] <Fourth Embodiment's Operation and Effects> Compared to the converters 5A to 5C, the converter 5D is positioned closer to the first proximal end 2P of the shaft 2. Also, in the extension direction D, the converter 5D is not positioned between the first tip 2D of the shaft 2 and the third tip 33D of the central part 33 of the balloon 30. Therefore, the balloon catheter 1D can maintain flexibility in the portion between the first tip 2D and the third tip 33D. Consequently, the balloon catheter 1D can maintain good passage of the balloon body 30D within the blood vessel.

[0105] <Fifth Embodiment (Balloon Catheter 1E)> The balloon catheter 1E according to the fifth embodiment has a balloon body 30E as the balloon body 3. The balloon body 30E differs from the balloon bodies 30A to 30D in that it has a plurality of converters 5E instead of converters 5A to 5D.

[0106] As shown in Figure 6, the multiple transformers 5E are provided as part of the balloon body 30E, more specifically, inside the multiple elements 4 of the balloon body 30E. The multiple transformers 5E include transformers 51, 52, and 53. Transformer 51 is provided inside element 41. Transformer 52 is provided inside element 42. Transformer 53 is provided inside element 43.

[0107] In the extension direction D, the central positions of the transformers 51 to 53 in the extension direction D coincide with the central position M of the central part 33 of the balloon 30. In the extension direction D, the positions of the transformers 51 to 53 coincide with some of the positions of the elements 41 to 43, including the central position M of the central part 33 of the balloon 30. The length of the transformers 51 to 53 in the extension direction D is shorter than the length of each of the elements 41 to 43 in the extension direction D. More specifically, the length of the transformers 51 to 53 in the extension direction D is shorter than the length of the central part 33 of the balloon 30 in the extension direction D.

[0108] Elements 41, 42, and 43 are each arranged at equal intervals in the circumferential direction on the outer surface of the film portion 300. Therefore, the converters 51, 52, and 53 provided on elements 41, 42, and 43 are also arranged at equal intervals in the circumferential direction.

[0109] <Operation and Effects of the Fifth Embodiment> Multiple converters 5E are provided on a part of the balloon body 30E. In this case, the balloon catheter 1E can directly vibrate the balloon body 30E with the multiple converters 5E, so the balloon body 30E can be vibrated efficiently.

[0110] Multiple converters 5E are provided on multiple elements 4. In this case, the multiple converters 5E can directly vibrate the multiple elements 4. Therefore, the balloon catheter 1E can vibrate the multiple elements 4 with maximum efficiency by means of the multiple converters 5E.

[0111] Multiple converters 5E are arranged at equal intervals in the circumferential direction. In this case, the balloon catheter 1E can have its multiple elements 4, which are evenly distributed in the circumferential direction, vibrated uniformly by the multiple converters 5E.

[0112] <Sixth Embodiment (Balloon Catheter 1F)> The balloon catheter 1F according to the sixth embodiment has a balloon body 30F as the balloon body 3. The balloon body 30F differs from the balloon bodies 30A to 30E in that it has a converter 5F instead of converters 5A to 5E.

[0113] As shown in Figure 7, the transformer 5F is provided on a part of the balloon body 30F, more specifically on the inner surface of the central part 33 of the balloon 30 of the balloon body 30F.

[0114] In the extension direction D, the central position of the transformer 5F in the extension direction D coincides with the central position M of the central part 33 of the balloon 30. The transformer 5F extends continuously in the circumferential direction. The length of the transformer 5F in the extension direction D is shorter than the length of the central part 33 of the balloon 30 in the extension direction D.

[0115] <Operation and Effects of the Sixth Embodiment> The converter 5F is provided continuously in the circumferential direction. In this case, multiple elements 4, which are distributed circumferentially around the balloon 30, can be vibrated.

[0116] <Modification> The present invention is not limited to the above embodiments, and various modifications are possible.

[0117] As the resin constituting the balloon 30, for example, polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; polyester resins such as polyethylene terephthalate and polyester elastomer; polyurethane resins such as polyurethane and polyurethane elastomer; polyphenylene sulfide resin; polyamide resins such as polyamide and polyamide elastomer; fluororesin, silicone resin; and natural rubber such as latex rubber may be used. Only one of these may be used, or two or more may be used in combination. Of these, polyamide resins, polyester resins, and polyurethane resins are preferably used. In particular, from the viewpoint of thinning the balloon 30 and flexibility, it is preferable to use an elastomer resin. For example, among polyamide resins, nylon 12 and nylon 11 are suitable materials for the balloon 30. Among these, nylon 12 is preferably used because it can be molded relatively easily during blow molding. Furthermore, from the viewpoint of thinning the balloon 30 and flexibility, polyamide elastomers such as polyether ester amide elastomer and polyamide ether elastomer are preferably used. Among these, polyether ester amide elastomers are preferred due to their high yield strength and good balloon dimensional stability.

[0118] The balloon body 3 may be coated with a hydrophilic coating. Examples of hydrophilic coating agents include hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone, and methyl vinyl ether maleic anhydride copolymer, or hydrophilic coating agents made from any combination thereof.

[0119] The balloon body 3 may be coated with a hydrophobic coating. Examples of hydrophobic coating agents include polytetrafluoroethylene (PTFE), fluoroethylene propylene (FEP), perfluoroalkoxyalkane (PFA), silicone oil, hydrophobic urethane resin, carbon coating, diamond coating, diamond-like carbon (DLC) coating, ceramic coating, and substances with low surface free energy terminated with alkyl groups or perfluoroalkyl groups.

[0120] By applying a hydrophilic or hydrophobic coating to the balloon body 3, the frictional resistance between the balloon body 3 and the blood vessel wall can be reduced. Therefore, the balloon catheter 1 can make it easier to form cracks in the blood vessel wall by preventing the vibration of the balloon body 3 caused by the converter 5 from being suppressed by frictional resistance.

[0121] The tip 23 is generally preferably made of a flexible material to maintain good permeability. On the other hand, in cases where treatment is performed by vibrating the tip 23 using a converter 5C provided inside the tip 23, such as in the balloon catheter 1C of the third embodiment, it is also possible to use a hard material for the tip 23. In this case, it becomes possible to treat the lesion by pressing the tip 23 against it and expanding the perforation hole.

[0122] The material of the tip 23 is not limited to the above embodiment. For example, the tip 23 may be made of metal, resin, or a combination of metal and resin. Examples of metal materials include stainless steel or metals or alloys such as nitinol. The tip 23 may be made by combining two or more different metal materials. The tip 23 may be made by combining two or more different resin materials.

[0123] To harden the chip 23, for example, a high-hardness polymer may be used as the material for the chip 23. Alternatively, fillers (glass fibers, carbon fibers) that improve the hardness of the chip 23 may be mixed in. Furthermore, the chip 23 may have a multilayer structure, with the outer layer being a high-hardness layer. In addition, the hardness of the chip 23 may be improved by heat treatment or UV curing after molding.

[0124] The number of elements 4 is not limited to three, but may be one, two, or four or more. The elements 4 may be provided only in a portion of the balloon 30 in the extension direction D. For example, the elements 4 may be provided only in one to four portions selected from the five portions of the balloon 30 (tip leg portion 31, tip tapered portion 32, central portion 33, base tapered portion 34, and base leg portion 35). Each of the elements 4 may have multiple sub-elements arranged at intervals in the extension direction D. Furthermore, each of the sub-elements may be provided with a transformer 5.

[0125] The multiple elements 4 may extend in the circumferential direction and be continuously arranged along the circumferential direction. Alternatively, the multiple elements 4 may be arranged in a helical shape along the extension direction D.

[0126] The amount of protrusion of the multiple elements 4 may differ for each of the five parts of the fixed balloon 30 (tip leg portion 31, tip tapered portion 32, central portion 33, base tapered portion 34, and base leg portion 35), or it may be the same for all parts.

[0127] The shape of each of the multiple elements 4 is not limited to the above embodiment. For example, the cross-sectional shape of each of the multiple elements 4 may be a blade shape, triangle, square, polygon, semicircle, part of a circle, roughly circular, fan shape, wedge shape, convex shape, spindle shape, and combinations thereof. Among these, triangles, squares, and polygons may include not only those with clearly defined corner vertices and straight edges, but also so-called rounded polygons with rounded corners, and those with at least a portion of their edges being curved. The shape of each of the multiple elements 4 may also be an irregular shape with indentations, notches, etc.

[0128] The multiple elements 4 do not necessarily have to be integrally molded with the balloon 30. For example, the multiple elements 4 may be fixed to the balloon 30 by being bonded to the balloon 30 with an adhesive. Alternatively, the multiple elements 4 and the balloon 30 may be fixed to the balloon 30 by welding. However, it is preferable that the multiple elements 4 and the balloon 30 are integrally molded with the balloon. This is preferable because the joint between the multiple elements 4 and the balloon 30 will not be lost even if the balloon 30 is repeatedly deformed between an inflated state and a deflated state.

[0129] The materials of the multiple elements 4 do not have to be the same as those of the balloon 30. For example, the multiple elements 4 may be made of metal, resin, or a combination of metal and resin. Examples of metal materials include stainless steel or metals or alloys such as nitinol. The multiple elements 4 may be made by combining two or more different metal materials. The multiple elements 4 may be made by combining two or more different resin materials.

[0130] The central position of the transformer 5A in the extension direction D and the central position M of the central part 33 of the balloon 30 do not necessarily have to coincide.

[0131] The end of the transformer 5A that is close to the first tip 2D may be located between the first tip 2D and the third tip 33D of the central portion 33 of the balloon 30 in the stretching direction D. In other words, the vicinity of the end of the transformer 5A that is close to the first tip 2D may protrude towards the first tip 2D side of the third tip 33D of the central portion 33 in the stretching direction D.

[0132] The end of the transformer 5A that is close to the first base end 2P may be located between the first base end 2P and the third base end 33P of the central portion 33 of the balloon 30 in the extension direction D. In other words, the vicinity of the end of the transformer 5A that is close to the first base end 2P may protrude towards the first base end 2P side of the third base end 33P of the central portion 33 in the extension direction D.

[0133] The end of the transformer 5B that is close to the first base end 2P may protrude towards the first base end 2P in the extension direction D, more than the end of the tip leg portion 31 that connects to the tip tapered portion 32.

[0134] The converter 5B may be spaced inward from the inner surface of the tip leg portion 31 of the balloon 30, or it may be in contact with the inner surface of the tip leg portion 31 of the balloon 30. The converter 5B may be held in place by being sandwiched between the tip leg portion 31 of the balloon 30 and the inner tube 22.

[0135] The end of the transformer 5D that is close to the first tip 2D may protrude in the extension direction D toward the first tip 2D side more than the third base end 33P. The end of the transformer 5D that is close to the first base end 2P may protrude in the extension direction D toward the first base end 2P side more than the end of the base tapered portion 34 that is connected to the base leg portion 35.

[0136] The transformers 5A, 5B, and 5D may be fixed to the inner surface of the inner tube 22. The transformers 5A, 5B, and 5D may be provided only on a portion of the inner or outer surface of the inner tube 22 in the circumferential direction. For example, the transformers 5A, 5B, and 5D may be provided discretely on multiple portions of the inner or outer surface of the inner tube 22 in the circumferential direction. In this case, the circumferential spacing of the discrete transformers 5A, 5B, and 5D may or may not be equal.

[0137] Multiple transformers 5A, 5B, and 5D may be provided and arranged in the extension direction D. In this case, the multiple transformers 5A, 5B, and 5D may be arranged with gaps between them in the extension direction D. The spacing between each of the multiple transformers 5A, 5B, and 5D may be equal or not.

[0138] The converters 5A, 5B, and 5D may be formed as part of the shaft 2. The converters 5A, 5B, and 5D may be continuously provided along the entire length of the inner tube 22 in the extension direction D.

[0139] The converter 5C may be provided on the outer surface of the chip 23 or on the inner surface of the through hole. When the converter 5C is provided on the outer or inner surface of the chip 23, it may be provided over the entire circumferential area or only on a part of the circumferential area. For example, the converter 5C may be provided discretely on multiple parts of the chip 23 in the circumferential direction. In this case, the circumferential spacing of the discrete converters 5C may be equal or not.

[0140] When the converter 5C is provided on the outer surface of the tip 23, the portion of the converter 5C near the end adjacent to the first base end 2P may protrude in the stretching direction D toward the first base end 2P more than the portion of the tip 23 adjacent to the first base end 2P. In this case, a portion of the converter 5C may be provided on the outer surface of the inner tube 22.

[0141] The converter 5C may be continuously provided within the chip 23 over the entire area in the extension direction D.

[0142] The entire chip 23 may be formed as a converter 5C.

[0143] Multiple transformers 5E may be provided continuously over the entire extension direction D of the multiple elements 4. Alternatively, multiple transformers 5E may be provided continuously over the entire extension direction D of the portion of the multiple elements 4 that is fixed to the central part 33 of the balloon 30. Transformers 5E may be provided on only one or two of the elements 41, 42, and 43.

[0144] Multiple elements 4 may contain a drug. The drug is not particularly limited as long as it is a pharmacologically active substance, and examples include gene therapy drugs, non-gene therapy drugs, small molecules, cells, and other drugs that are accepted as pharmaceuticals. In particular, when the balloon catheter 1 is used to suppress restenosis of blood vessels after treatment in angioplasty, anti-restenotic agents such as antiproliferative agents and immunosuppressants are preferably used as the drug. Examples of such drugs include paclitaxel, sirolimus (rapamycin), everolimus, and zotarolimus.

[0145] Because the drug is contained in multiple elements 4, the affinity between the multiple elements 4 and the drug is less likely to be lost even if the balloon 30 is repeatedly inserted and removed. Therefore, by vibrating the multiple elements 4 with the converter 5, the drug contained in the multiple elements 4 can be efficiently penetrated into the lesion. The drug contained in the multiple elements 4 can act on the lesion and enhance the therapeutic effect on the lesion.

[0146] The embodiments in which the drug is contained in multiple elements 4 are not particularly limited, but may include the following as specific examples: • The drug is directly applied to the surface of multiple elements 4. • The drug penetrates into the interior of multiple elements 4. • Microcapsules containing the drug are contained inside multiple elements 4. • Nanoparticles or gels containing the drug are attached to the surface of multiple elements 4.

[0147] In this case, by vibrating multiple elements 4 with the converter 5, the drugs contained in the multiple elements 4 can be efficiently penetrated into the lesion.

[0148] Furthermore, the amount of chemical agent contained in the multiple elements 4 is less than in the case where the multiple elements 4 do not vibrate. Therefore, it is possible to suppress the hardening of the multiple elements 4 by the chemical agent, which reduces the passability of the balloon body 30A.

[0149] Furthermore, the balloon 30 may contain a drug.

[0150] Multiple transformers 51, 52, and 53 may be provided and arranged in the extension direction D. In this case, the multiple transformers 51, 52, and 53 may be spaced apart in the extension direction D. The spacing between the multiple transformers 51, 52, and 53 may be equal or not.

[0151] Each of the multiple transformers 5E may be provided on at least a portion of the outer surface of each of the multiple elements 4. For example, each of the multiple transformers 5E may be provided on a portion of the outer surface of each of the multiple elements 4, including the tip portion 40P.

[0152] The entirety of the multiple elements 41, 42, and 43 may be formed as transformers 51, 52, and 53.

[0153] The transformer 5F may be provided only on a portion of the inner surface of the balloon 30 in the circumferential direction. For example, the transformer 5F may be provided discretely on multiple portions of the inner surface of the balloon 30 in the circumferential direction. In this case, the circumferential spacing of the discrete transformer 5F may or may not be equal.

[0154] The central position of the transformer 5F in the extension direction D does not have to coincide with the central position M of the central part 33 of the balloon 30. The transformer 5F may be fixed to the outer surface of the balloon 30. The transformer 5F may be fixed to the inner surface and outer surface of the balloon 30, respectively. In this case, the positions of the transformers 5F fixed to the inner surface and outer surface of the balloon 30 in the extension direction D may coincide or differ.

[0155] Multiple transformers 5F may be provided in the extension direction D. In this case, the multiple transformers 5F may be arranged with gaps between them in the extension direction D. The spacing between each of the multiple transformers 5F may be equal or not.

[0156] The balloon 30 may have a two-layer structure. The converter 5F may be sandwiched between the two layers. The converter 5F may be formed as part of the balloon 30. The converter 5F may be continuously provided over the entire length in the stretching direction D on either the inner or outer surface of the balloon 30.

[0157] As the transformer 5F provided on a part of the balloon 30 of the balloon body 30F, a soft material such as a piezoelectric resin may be used so as not to hinder the minimization of the diameter when the balloon 30 is in a contracted state. This makes it easier for the balloon 30 to deform from an inflated state to a contracted state, thereby improving the passage of the balloon body 30A through blood vessels.

[0158] The conductors connecting the converter 5 and the AC power supply 9 may be fixed to either the inner and outer surfaces of the outer tube 21 or the inner and outer surfaces of the inner tube 22. Alternatively, the conductors may not be fixed to the outer tube 21 or the inner tube 22, but may be placed inside the lumen of either the outer tube 21 or the inner tube 22.

[0159] Two or more of the converters 5A to 5F may be provided on a common balloon catheter 1.

[0160] The vibration frequencies of the converters 5A to 5F in the above embodiment are examples only, and other frequencies may be used. The converters 5A to 5F may also be other devices capable of converting electrical energy into vibrational energy. For example, the converters 5A to 5F may be small motors, solenoid vibrators, etc.

Claims

1. A balloon catheter comprising: a shaft extending in the extension direction from a first tip to a first base; a balloon body provided on the shaft, the balloon being configured to expand radially with respect to the central axis of the shaft and covering the vicinity of the first tip of the shaft; an element being fixed entirely to at least a portion of the balloon; and a converter capable of continuously vibrating by converting electrical energy into vibrational energy.

2. The balloon catheter according to claim 1, characterized in that the converter vibrates the element continuously.

3. The balloon catheter according to claim 1, characterized in that the element is integrally molded with the balloon.

4. The balloon catheter according to claim 1, characterized in that the converter is provided inside the balloon in the radial direction with respect to the central axis.

5. The balloon catheter according to claim 4, characterized in that the converter is provided on the portion of the shaft located inward of the balloon in the radial direction.

6. The balloon catheter according to claim 1, characterized in that the converter is provided on the balloon body.

7. The balloon catheter according to claim 6, characterized in that the converter is provided on the element.

8. The balloon catheter according to any one of claims 4, 6, or 7, characterized in that the converter is provided in the circumferential direction with respect to the central axis.

9. The balloon catheter according to claim 8, characterized in that the converters are provided at equal intervals in the circumferential direction.

10. The balloon extends from a second tip to a second base, the distance in the extension direction between the first tip and the second tip is smaller than the distance in the extension direction between the first tip and the second base, the balloon has a tip leg portion, a tip tapered portion, a central portion, a base tapered portion, and a base leg portion, the central portion has a cylindrical shape extending in the extension direction, the tip tapered portion extends from a third tip adjacent to the second tip of the central portion toward the opposite side of the central portion while decreasing in diameter, the tip leg portion extends from the end of the tip tapered portion adjacent to the second tip to the second tip and connects to the shaft, the base tapered portion extends from the end of the central portion adjacent to the second base portion toward the opposite side of the central portion while decreasing in diameter, The balloon catheter according to claim 1, characterized in that the proximal leg portion extends from the end of the proximal tapered portion adjacent to the second proximal end to the second proximal end and is connected to the shaft, and in the extension direction, the position of at least a part of the transformer coincides with the position of at least a part of the central portion.

11. The balloon extends from a second tip to a second base, the distance in the extension direction between the first tip and the second tip is smaller than the distance in the extension direction between the first tip and the second base, the balloon has a tip leg portion, a tip tapered portion, a central portion, a base tapered portion, and a base leg portion, the central portion has a cylindrical shape extending in the extension direction, the tip tapered portion extends from a third tip adjacent to the second tip of the central portion toward the opposite side of the central portion while decreasing in diameter, the tip leg portion extends from the end of the tip tapered portion adjacent to the second tip to the second tip and connects to the shaft, the base tapered portion extends from the end of the central portion adjacent to the second base portion toward the opposite side of the central portion while decreasing in diameter, The balloon catheter according to claim 1, wherein the proximal leg portion extends from the end of the proximal tapered portion adjacent to the second proximal end to the second proximal end and is connected to the shaft, and in the extension direction, the position of at least a part of the transformer body coincides with the position of at least a part of the position between the first tip and the third tip.

12. The balloon catheter according to claim 11, characterized in that, in the extension direction, the position of at least a portion of the transformer coincides with the position of at least a portion of the position between the first tip and the second tip.

13. The balloon extends from a second tip to a second base, the distance in the extension direction between the first tip and the second tip is smaller than the distance in the extension direction between the first tip and the second base, the balloon has a tip leg portion, a tip tapered portion, a central portion, a base tapered portion, and a base leg portion, the central portion has a cylindrical shape extending in the extension direction, the tip tapered portion extends from a third tip adjacent to the second tip of the central portion toward the opposite side of the central portion while decreasing in diameter, the tip leg portion extends from the end of the tip tapered portion adjacent to the second tip to the second tip and connects to the shaft, the base tapered portion extends from the end of the central portion adjacent to the second base portion toward the opposite side of the central portion while decreasing in diameter, The balloon catheter according to claim 1, characterized in that the proximal leg portion extends from the end of the proximal tapered portion adjacent to the second proximal end to the second proximal end and is connected to the shaft, and in the extension direction, the position of at least a part of the transformer does not coincide with the position of at least a part of the position between the first tip and the third tip.

14. The balloon catheter according to claim 1, characterized in that the converter vibrates continuously at a frequency of 1 MHz to 10 MHz.

15. The balloon catheter according to claim 14, characterized in that the converter vibrates continuously at a frequency of 2 MHz to 3 MHz.

16. The balloon catheter according to claim 1, characterized in that the converter includes a piezoelectric element.

17. The balloon catheter according to claim 1, characterized in that the element contains a drug.

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