HK40006600B

HK40006600B - Device for delivering mechanical waves through a balloon catheter

Info

Publication number: HK40006600B
Application number: HK19130117.5A
Authority: HK
Inventors: M·布鲁耶特; L-P·里埃尔; S·迪恩; F·贝利多; P·拉卡斯; M·阿波德; D·桑托扬尼
Original assignee: 莱斯桑柏特医疗解决方案股份有限公司
Priority date: 2016-11-04
Filing date: 2017-11-03
Publication date: 2023-08-25

Description

Device for delivering mechanical waves through balloon catheter

Technical Field

The present invention relates to the field of medical devices and methods, and in particular to those for medical treatment of cells, tissues and organs using mechanical waves such as ultrasound and shock waves, and more particularly to the treatment of lesions that have been hardened by the presence of calcification.

Background

Non-invasive therapies using ultrasound waves or shock waves are commonly used to treat a variety of medical conditions, such as kidney stones and prostate cancer. They are attractive because the source of the mechanical waves is external to the patient to be treated and therefore the process is not invasive. By design of the mechanical energy source, this energy is usually concentrated on the target to be treated in the body. However, this technique has limitations. For example, it may be difficult to obtain the exact location of the target due to limitations of the imaging method used. Moreover, due to the physical limitations of the focused wave itself and the heterogeneity within the various tissues and organs through which the wave travels, the energy may not be focused at the exact desired location. Finally, the energy density at the target may be insufficient to complete the desired process.

Some balloon devices include built-in shock wave generators, but this requires high voltage and high current to be delivered in the patient, with significant safety challenges. Some other balloon devices contain a source of ultrasonic energy, but the available power levels may not be sufficient for many applications, especially those requiring fracturing and/or erosion of calcified tissue structures.

Accordingly, there is a need for an improved method and apparatus for delivering mechanical waves.

Disclosure of Invention

According to a first broad aspect, there is provided an apparatus for delivering mechanical waves to treat a lesion present in a blood vessel, comprising: a catheter body extending along a longitudinal axis between a first proximal end and a first distal end; an inflatable balloon secured to the catheter body and adjustable between an inflated configuration and a deflated configuration, the inflatable balloon being fluidly connectable to a fluid source to change the configuration of the balloon; and at least one mechanical waveguide extending between a second proximal end and a second distal end operatively connected to the mechanical wave source for propagating mechanical waves from the second proximal end to the second distal end, the mechanical waveguide being secured to one of the inflatable balloon and the catheter.

In one embodiment, the inflatable balloon is adjacent to the first distal end of the catheter.

In one embodiment, the inflatable balloon is secured around at least a portion of the catheter device.

In one embodiment, at least one mechanical waveguide is secured to an outer surface of the inflatable balloon.

In one embodiment, the second distal end of the at least one mechanical waveguide is coplanar with the first distal end of the catheter body when the inflatable balloon is inflated.

In another embodiment, the second distal end of the at least one mechanical waveguide protrudes from the first distal end of the catheter body when the inflatable balloon is inflated.

In another embodiment, the second distal end of the at least one mechanical waveguide is located between the proximal and distal ends of the catheter body when the inflatable balloon is inflated.

In one embodiment, at least one mechanical waveguide is movably secured to an outer surface of the inflatable balloon.

In one embodiment, the device further comprises at least one deflector, each deflector being secured to an outer surface of the inflatable balloon and facing the second distal end of a respective one of the at least one mechanical waveguides.

In one embodiment, the deflector is adapted to deflect the mechanical wave radially.

In one embodiment, at least a portion of the at least one mechanical waveguide is inserted within the inflatable balloon.

In one embodiment, the balloon includes an inner wall facing the catheter body, and an outer wall including at least one aperture on a distal face thereof, the at least one mechanical waveguide extending at least partially between the inner wall and the outer wall, each mechanical waveguide passing through a respective one of the at least one aperture.

In one embodiment, the inner wall has a substantially circular cross-sectional shape and the outer wall defines at least one protrusion, each protrusion receiving a respective one of the at least one mechanical waveguide.

In another embodiment, the outer wall has a substantially circular cross-sectional shape and the inner wall defines at least one groove, each groove receiving a respective one of the at least one mechanical waveguide.

In one embodiment, the second distal end of the at least one mechanical waveguide is located outside of the inflatable balloon.

In one embodiment, the catheter body includes an inner wall and an outer wall spaced apart from the inner wall, the at least one mechanical waveguide interposed between the inner wall and the outer wall, the outer wall including at least one aperture and the at least one mechanical waveguide interposed in a respective one of the at least one aperture so as to extend partially within the inflatable balloon.

In one embodiment, at least one mechanical waveguide is sealingly inserted into a respective one of the at least one aperture.

In one embodiment, the second distal end of the at least one mechanical waveguide is positioned within the inflatable balloon.

In one embodiment, the second distal end of the at least one mechanical waveguide abuts the inner surface of the inflatable balloon.

In one embodiment, the device further comprises at least one deflector, each deflector being secured to the inner surface of the inflatable balloon and facing the second distal end of a respective one of the at least one mechanical waveguides.

In one embodiment, the inflatable balloon includes at least one hole, and the second distal end of the at least one mechanical waveguide is sealingly inserted into a respective one of the at least one hole.

In one embodiment, the second distal end of the at least one mechanical waveguide protrudes outside of the inflatable balloon.

In one embodiment, the second distal end of the at least one mechanical waveguide is straight.

In another embodiment, the second distal end of the at least one mechanical waveguide is curved outwardly.

In one embodiment, the at least one mechanical waveguide comprises a plurality of mechanical waveguides.

In one embodiment, the mechanical waveguides are arranged according to a desired energy deposition pattern when the inflatable balloon is in the inflated configuration.

In one embodiment, the mechanical waveguides are evenly distributed around the inflatable balloon.

In one embodiment, the mechanical waveguides are arranged according to at least two rows when the inflatable balloon is in the deflated configuration, and the mechanical waveguides are arranged according to a single row when the inflatable balloon is in the inflated configuration.

In one embodiment, at least a portion of at least one mechanical waveguide is covered with a sheath.

In one embodiment, the device further comprises at least one waveguide into which a respective one of the at least one mechanical waveguide is inserted.

In one embodiment, the outer surface of the inflatable balloon is coated with one of the following: drugs, hydrophilic coatings, hydrophobic coatings, and friction reducing coatings.

In one embodiment, the sheath is coated with a drug.

In one embodiment, at least one mechanical waveguide is adapted for propagating mechanical pulses of high amplitude and short duration.

For the purposes of this specification, a mechanical wave is understood to be a signal having any amplitude, duration, waveform, frequency, and/or the like. For example, the mechanical wave may have high/low amplitude, short/long duration, different waveforms and any frequency content.

For the purposes of this specification, a mechanical pulse is understood to be a mechanical wave of short duration. The duration of the mechanical pulse is about 1/fc.

In one embodiment, the center frequency fc of the mechanical pulses is between about 20kHz and about 10 MHz. In one embodiment, the amplitude of the mechanical pulse is between about 10MPa and about 1000MPa when reaching the distal end of the catheter device. In one embodiment, the duration of the mechanical pulse is about 1/fc when the distal end of the catheter device is reached.

Drawings

Other features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings in which:

FIG. 1 is a block diagram illustrating a system for treating a lesion according to one embodiment;

FIG. 2 is a cross-sectional view of a balloon catheter including a single mechanical waveguide and a balloon in a deflated state, according to one embodiment;

FIG. 3 is a cross-sectional view of the balloon catheter of FIG. 2 as the balloon is inflated;

FIG. 4A is a cross-sectional view of a catheter balloon according to one embodiment, including four mechanical waveguides secured outside the balloon;

FIG. 4B is a front view of the catheter of FIG. 4A when inserted into a blood vessel, according to one embodiment;

FIG. 5 schematically illustrates a balloon catheter according to an embodiment, wherein the mechanical waveguides are evenly distributed around the circumference of the balloon;

FIG. 6 schematically illustrates a balloon catheter according to one embodiment, in which the mechanical waveguides are concentrated in a single region along the circumference of the balloon;

FIG. 7 is a perspective view of a balloon catheter device according to one embodiment, including a catheter shaft, a transparent balloon secured to the catheter, and two mechanical waveguides secured to an outer surface of the transparent balloon;

FIG. 8 is a cross-sectional view of the balloon catheter device of FIG. 7;

FIG. 9 is a transverse cross-sectional view of a balloon catheter device according to one embodiment, including a catheter shaft, a balloon secured to the catheter, and having an outer wall and an inner wall defining six grooves, and six mechanical waveguides, each inserted into a respective groove;

FIG. 10 is a partial longitudinal cross-sectional view of the balloon catheter device of FIG. 9;

FIG. 11 is a transverse cross-sectional view of a balloon catheter device according to one embodiment, including a catheter shaft, a balloon secured to the catheter, and having an outer wall and an inner wall defining six protrusions, and six mechanical waveguides, each inserted into a respective groove;

FIG. 12 is a partial longitudinal cross-sectional view of the balloon catheter device of FIG. 11;

FIG. 13 is a perspective view of a balloon catheter device according to one embodiment, including a catheter shaft, a transparent balloon secured to the catheter, and two mechanical waveguides inserted into the transparent balloon and having portions secured to the inner surface of the balloon;

FIG. 14 is a perspective view of a balloon catheter device according to one embodiment, including a catheter shaft, a transparent balloon secured to the catheter, and two mechanical waveguides inserted into the transparent balloon and having distal ends proximate an inner surface of the balloon;

FIG. 15 is a perspective view of a balloon catheter device according to one embodiment, including a catheter shaft, a transparent balloon secured to the catheter, and two mechanical waveguides inserted into the transparent balloon and having free distal ends located within the balloon;

FIG. 16 illustrates a mechanical waveguide secured to the balloon outer surface and having a curved distal end, according to one embodiment;

FIG. 17 illustrates a mechanical waveguide and deflector, both secured to an outer surface of a balloon, according to one embodiment;

FIG. 18 illustrates a mechanical waveguide secured to an inner surface of a balloon and having a curved distal end protruding outside the balloon, according to one embodiment;

FIG. 19 illustrates a mechanical waveguide and deflector, both secured to the inner surface of a balloon, according to one embodiment;

FIG. 20 illustrates a mechanical waveguide secured to an inner surface of a balloon and having a curved distal end proximate the inner surface of the balloon, according to one embodiment; and

FIG. 21 is a perspective view of a balloon catheter device according to one embodiment, including a catheter shaft, a transparent balloon secured to the catheter, and two mechanical waveguides inserted into the transparent balloon and having portions secured to an outer surface of the catheter shaft;

It should be noted that throughout the appended drawings, like features are identified by like reference numerals.

Detailed Description

Fig. 1 illustrates one embodiment of a system 10 for treating a lesion 12 to describe a particular environment in which the present catheter will be used. The system 10 includes a pulse generator 14 and a transmission member 16 adapted to propagate a mechanical wave or pulse.

The pulse generator 14 is adapted to generate mechanical pulses of high amplitude and short duration. The pulse generator 54 may include at least one broadband source and/or at least one narrowband source. The narrowband source or the broadband source may be an electromechanical transducer. The pulse generator 14 may include a spatial concentrator to focus the output of at least one source to a focal zone at the proximal end of the transmission member 16 to couple the generated pulses therein.

In one embodiment, the high amplitude and short duration mechanical pulses are mechanical pulses having a duration of less than about 10 microseconds and an amplitude of equal to or greater than about 10 bars.

A transmission member 16, such as a mechanical waveguide, extends between a first or proximal end operatively connected to the pulse generator 14 and a second or distal end. The transmission member 16 is adapted to receive the mechanical pulse at its proximal end and to propagate the mechanical pulse to its distal end. When it reaches the distal end, the mechanical pulse is at least partially transmitted to produce a transmitted pulse that propagates outside the transmission member 16. It will be appreciated that the pulse may also be reflected by the distal end and propagate back in the transmission member 16 towards its proximal end. The transmitted mechanical pulse corresponds to a mechanical pulse propagating in a medium surrounding the distal end of the transmission member 16 to the lesion 12. The transmitted pulse propagates further into the lesion 12, which may create a crack within the lesion 12 and eventually cleave or fragment the lesion 12.

In embodiments where the distal end of the transmission member 16 is proximate to the lesion 12, the mechanical waveguide 16 may be further used to destroy the lesion 12 and/or drill holes in the lesion 12. The transmission of the mechanical pulse at the distal end of the transmission member 16 produces movement of the distal end of the transmission member 16. This movement may be along the longitudinal axis of the transmission member 16. Alternatively, the movement may be perpendicular to the longitudinal axis or it may be a combination of movement along the longitudinal axis and movement perpendicular to the longitudinal axis of the transmission member. During this movement, the distal end of the delivery member 16 typically first moves toward the lesion 12 and then moves back to its original position. It should be appreciated that the motion may be reversed (i.e., the distal end may first move away from the lesion 12 and then toward the lesion 12) depending on the polarity of the mechanical pulse reaching the distal end of the transmission member 16. As a plurality of different mechanical pulses are continuously transmitted at the distal end of the transmission member 16, the movement of the distal end may be regarded as a rock drill movement that may be used for treating the lesion 12.

Fig. 2 illustrates one embodiment of a balloon catheter 20 that may be used as a transmission member, such as transmission member 16 of fig. 1, for propagating mechanical waves or pulses from an extracorporeal mechanical energy source (e.g., a source of short duration shock waves or ultrasonic pulses).

The balloon catheter 20 includes a centrally located catheter shaft or elongate hollow body 22, a balloon 24 mounted on the catheter shaft 22, and a mechanical waveguide 26 mounted on an outer surface of the balloon 24. The catheter shaft 22 extends between a proximal end 28 and a distal end 30, the distal end 30 being adapted for insertion into a blood vessel of a patient, such as an artery. The catheter shaft 22 is hollow to allow a guidewire to extend through from its proximal end 28 to its distal end 30.

The balloon 24 is secured to the catheter shaft 22 near its distal end 30. The balloon 24 is sealingly secured around the outer surface of the catheter shaft 22 to enclose the catheter shaft 22. In fig. 2, balloon 24 is shown in a deflated state/configuration.

The mechanical waveguide 26 is adapted for propagating mechanical waves, such as shock waves or ultrasonic pulses, which are generated by a mechanical wave source (not shown) located outside the patient's body. The proximal end of the mechanical waveguide 26 is operatively connected to a mechanical wave source such that the mechanical wave propagates along the mechanical waveguide 26 to its distal end.

Fig. 3 shows the balloon catheter 20 when the balloon is in an expanded state/configuration. As shown in fig. 3, the mechanical waveguide 26 is secured to the outer surface of the balloon 24 at a connection point 32. As the balloon 24 expands, the mechanical waveguide 26 follows the lateral movement of the balloon 24 such that the distance d between the mechanical waveguide 26 and the catheter shaft 22 increases.

It will be appreciated by those skilled in the art that the balloon may have a similar structure and operation to existing balloon medical devices in that it may comprise a so-called single-lumen or dual-lumen structure, and it may be of the so-called compliant, super-compliant, semi-compliant or non-compliant type, as is known in the art.

In one embodiment, when the balloon 24 is inflated, the location of the connection point 32 on the surface of the balloon 24 is selected as a function of the desired orientation or desired position of the mechanical waveguide 26 relative to the catheter shaft 22 and/or the orientation of the distal end of the mechanical waveguide 26 relative to the distal end 30 of the catheter shaft 22. For example, if the connection point 32 is selected to be on a portion of the balloon 24 adjacent the distal end 30 of the catheter, the distal end of the mechanical waveguide 26 will be oriented toward a longitudinal axis along which the catheter shaft 22 extends when the balloon 24 is inflated. In another example, if the connection point 32 is selected to be on a portion of the balloon 24 opposite the distal end 30 of the catheter, the distal end of the mechanical waveguide 26 will be oriented away from the longitudinal axis when the balloon 24 is inflated.

It should be appreciated that any suitable means, device or system for inflating balloon 24 may be used. For example, a mechanical device such as a pump may be used to inflate balloon 24. In another example, a fluid delivery system may be used to inflate balloon 24. The fluid delivery system includes a fluid source fluidly connected to the balloon 24. The fluid source is adapted to inject a fluid, such as air or water, into the balloon 24 to inflate the balloon 24 and aspirate the fluid from the balloon 24 to deflate the balloon 24.

In one embodiment, the mechanical waveguide 26 is fixedly secured to the balloon 24. In another embodiment, the mechanical waveguide 26 is movably secured to the balloon 24. For example, the mechanical waveguide 26 may be movable relative to the balloon 24 along a longitudinal axis along which the catheter shaft 22 extends while having a fixed position relative to the balloon 24 along an axis perpendicular to the surface of the balloon 24. For example, at least one ring may be secured to the outer surface of the balloon 24 at various locations along the length of the balloon 24, and the mechanical waveguide 26 may be inserted into the ring and slid along the length of the balloon 24. In another example, a tubular structure such as a sheath may be secured to an outer surface of the balloon 24 along at least a portion of the length of the balloon 24, and a mechanical waveguide 26 may be inserted into the sheath and slid within the sheath so as to be longitudinally movable relative to the balloon 24.

While in the embodiment shown in fig. 2 and 3, the mechanical waveguide 26 is secured to the balloon 24 at a single connection point 32, it should be understood that other configurations are possible. For example, the mechanical waveguide 26 may be secured to the balloon 24 at several discrete connection points along the length of the balloon 24. In another example, at least a portion of the mechanical waveguide 26 may be continuously secured to at least a portion of the balloon 24.

In one embodiment, the mechanical waveguide 26 is further fixedly or movably secured to a portion of the catheter shaft 22 not covered by the balloon 24.

While in the illustrated embodiment, the mechanical waveguide 26 is secured to the balloon 24 so as to be parallel to the catheter shaft 22, it should be understood that other configurations are possible. For example, the mechanical waveguide 26 may be wrapped around the balloon 24 in a spiral fashion. In this case, it should be appreciated that the mechanical waveguide 26 is movably secured to the balloon 24 so as to follow the inflation of the balloon 26.

In one embodiment, the balloon includes a single outer consumable wall, such as wall 24. In this case, the fluid used to inflate the balloon 24 is included between the inner surface of the outer wall and the catheter shaft 22. In another embodiment, the balloon may include an outer wall and an inner wall that are secured together at the distal end of the balloon. The inner wall may have a tubular shape defining a bore into which the catheter shaft 22 is inserted and the interior is fixedly secured to the catheter shaft. At the proximal end of the balloon, a tube for injecting and/or aspirating fluid between the inner and outer walls of the balloon may be inserted between the inner and outer walls, which are sealingly secured together and/or around the tube.

While the distal end of the mechanical waveguide 26 has a linear shape, it should be understood that other configurations are possible. For example, the distal end of the mechanical waveguide 26 may be curved inwardly toward the longitudinal axis or outwardly away from the longitudinal axis. The distal tip of the mechanical waveguide 26 may take on a variety of shapes. For example, the tip may be rounded, square, beveled, or a beveled plane relative to the axis of the distal tip. Other geometries are also possible.

It should be appreciated that the position of the distal end of the mechanical waveguide 26 relative to the distal end 30 of the catheter may vary as the balloon 24 is inflated. In the illustrated embodiment, the distal end of the mechanical waveguide 26 is substantially coplanar with the distal end 30 of the catheter shaft 22 when the balloon 24 is inflated. In another embodiment, the distal end of the mechanical waveguide 26 may protrude forward from the distal end 30 of the catheter shaft 22 away from the distal end 30 of the catheter shaft 22 when the balloon 24 is inflated. In another embodiment, the distal end of the mechanical waveguide 26 is positioned between the proximal end 28 and the distal end 30 of the catheter shaft 22 when the balloon 24 is inflated.

Although the mechanical waveguide 26 is fixed to the outer surface of the balloon 24, one skilled in the art will appreciate that the mechanical waveguide 26 may be inserted into the balloon 24. In this case, the mechanical waveguide 26 may be fixed to the inner surface of the balloon 24.

While balloon catheter 20 includes a single mechanical waveguide 26, fig. 4A and 4B illustrate a balloon catheter 40 that includes two mechanical waveguides 42 and 48. Balloon catheter 40 also includes a catheter shaft 50 and a balloon 52 secured to catheter shaft 50. It should be understood that the number of mechanical waveguides 42 and 48 is merely exemplary.

A guidewire is inserted into the catheter shaft 50 and used to guide the balloon 52 to the target lesion 54 to be treated. Balloon catheter 40 is inserted into a patient's blood vessel 56 until balloon 52 is adjacent lesion 54. The mechanical waveguides 42 and 48 are arranged around the balloon 52 to obtain the desired energy deposition pattern at the lesion to be treated, either around the balloon 52 or at the distal tip of the balloon 52. In the illustrated embodiment, the mechanical waveguides 42 and 48 are secured to the outer surface of the balloon 52 and are evenly distributed around the circumference of the balloon 52 when inflated. The distal ends of the mechanical waveguides 42 and 48 are bent outwardly away from the catheter shaft 50 to allow treatment of lesions located around the balloon 52.

Once the balloon catheter 40 is inserted into the blood vessel 54 such that the balloon 52 is in place relative to the lesion 54 to be treated, the balloon 52 is inflated. During inflation of balloon 52, the radial positions of mechanical waveguides 42 and 48 are moved outwardly until at least one of mechanical waveguides 42 and 48 reaches the inner surface of vessel 56 to be treated or is in a desired position relative to lesion 54 to be treated. Once the mechanical waveguides have been sufficiently positioned, mechanical waves, such as shock waves or ultrasonic pulses, are generated and propagated along at least one of the mechanical waveguides 42 and 48 to treat the lesion 54.

While the mechanical waveguides 42 and 48 extend linearly along a longitudinal axis corresponding to the longitudinal axis of the catheter shaft 50, it should be understood that other configurations are possible. For example, the mechanical waveguides 42 and 48 may be arranged circumferentially along the balloon perimeter, or they may be arranged in a spiral arrangement around the balloon perimeter. Similarly, while the distal ends of the mechanical waveguides 42 and 48 are bent outwardly, other configurations are possible. For example, the distal ends of some of the mechanical waveguides 42 and 48 may be straightened to treat lesions located in front of the balloon 52, while the distal ends of other mechanical waveguides 42 and 48 may be bent outward to treat lesions located around the balloon 52.

While the distal ends of the mechanical waveguides 42 and 48 are substantially coplanar with the distal end of the catheter shaft 50, it should be understood that the distal ends of the mechanical waveguides 42 and 48 may vary relative to the distal end of the catheter shaft 50. For example, the distal ends of some of the mechanical waveguides 42 and 48 may protrude from the distal end of the catheter shaft 50 to treat lesions located forward of the catheter shaft 50, while the distal ends of other mechanical waveguides 42 and 48 may be located between the proximal and distal ends of the catheter shaft 50 to treat lesions located around the circumference of the balloon 52.

In one embodiment, the location of treatment and/or the pattern of energy deposition at the lesion is adjusted by appropriately selecting the shape of balloon 52 and sufficiently inflating balloon 52, i.e., controlling inflation of balloon 52, such as by controlling the pressure of the fluid injected into balloon 52. Balloon 52 may be gradually inflated as treatment progresses, allowing the mechanical waveguide to treat different lesion areas sequentially at increasing diameters.

While fig. 4A and 4B illustrate balloon catheter 40 with mechanical waveguides 42 and 48 positioned on the outer surface of balloon 52, fig. 5 and 6 illustrate an embodiment of a balloon catheter with mechanical waveguides inserted into the balloon.

Fig. 5 shows a balloon catheter 60 comprising a catheter shaft 62, an inflatable balloon 64 fixed to the catheter shaft 62 and a mechanical waveguide 66 inserted into the balloon 64. The mechanical waveguides 66 are evenly and symmetrically distributed around the inner circumference of the balloon 64.

While the mechanical waveguides 66 are evenly and symmetrically distributed around the inner circumference of the balloon 64, other configurations are possible. For example, fig. 6 shows a balloon catheter 70 that includes a catheter shaft 72, an inflatable balloon 74 secured to the catheter shaft 72, and seven mechanical waveguides 76 asymmetrically inserted into the balloon 74. The mechanical waveguide 76 is concentrated on a given region 78 of the inner circumference of the balloon 74. In another example, the mechanical waveguides may be asymmetrically arranged and/or concentrated at different locations around the circumference of the balloon.

In embodiments where the mechanical waveguide is inserted into the balloon, the distal end of the mechanical waveguide may extend outside the balloon. In another embodiment, the distal end of the mechanical waveguide may be located within the balloon. In this case, the distal end of the mechanical waveguide may be in contact with the inner surface of the balloon, and the balloon may be made of a material that allows good acoustic coupling between the waveguide and tissue outside the balloon. In another embodiment, some of the mechanical waveguides may extend outside of the balloon, while the distal ends of other mechanical waveguides may be located within the balloon.

It should be appreciated that the number, location, shape and size of the mechanical waveguides may be selected according to the desired energy deposition mode of the balloon catheter device.

In embodiments where they are disposed on the outer surface of the balloon, the mechanical waveguides may be covered by an outer sheath. In this case, the distal end of the mechanical waveguide may be located inside the sheath or may protrude outside the sheath. If it remains within the sheath, the distal end of the mechanical waveguide may be in physical contact with the inner surface of the sheath, and the sheath may be fabricated from a material that allows good acoustic coupling between the waveguide and tissue outside the sheath.

In one embodiment, the mechanical waveguides may be individually enclosed in a tube, whether the mechanical waveguides are located inside or outside the balloon. The tube may be made of a sound insulating material to minimize mechanical energy loss before the distal end of the waveguide.

In embodiments where the mechanical waveguide is located on the outer surface of the balloon, the mechanical waveguide may be arranged according to more than one row or layer when the balloon is deflated, and according to a single row or layer when the balloon is inflated.

Fig. 7 and 8 illustrate a balloon catheter 100 that includes two mechanical waveguides 105, the mechanical waveguides 105 being secured on opposite sides of the outer surface of the balloon 104. Balloon catheter 100 also includes a catheter shaft 101, with catheter shaft 101 extending between a proximal end 108 of catheter balloon 100 and a distal end 107 of catheter balloon 100. The catheter shaft 101 includes a distal tip portion 102 adjacent the distal end 107 of the balloon catheter 100, the distal tip portion 102 decreasing in diameter toward the distal end 107 of the catheter balloon 100. The catheter shaft 101 is provided with two radio-opaque markers 103, each marker 103 being fixed to the outer surface of the catheter shaft 101 at a respective position along its length to indicate the extent of the length of the balloon 104. The catheter shaft 101 is provided with a central lumen 109, the central lumen 109 extending between its proximal and distal ends for insertion of a guidewire therein. At the proximal end 108 of the balloon catheter 100, the mechanical waveguide is disposed around the catheter shaft 101 and covered by a sheath 106, the sheath 106 terminating at its distal end portion 110 before the proximal end of the balloon 104. The proximal end of the mechanical waveguide (not shown) is operatively connected to the mechanical pulse generator. The portion of the mechanical waveguide 105 fixed to the balloon 104 follows the outer surface of the balloon 104 and moves according to the inflation/compression of the balloon 104. The distal tip 111 of the mechanical waveguide terminates at a distance "L" from the distal end of the balloon 104.

In some embodiments, the balloon may include a double wall, and the mechanical waveguide is inserted between or within the two walls of the balloon.

Fig. 9 and 10 illustrate a balloon catheter comprising a catheter shaft 121, the catheter shaft 121 having a tubular shape and extending between a proximal end and a distal end. The catheter shaft 121 is provided with a central bore or lumen 129 extending between the proximal and distal ends of the catheter shaft 121. An inflatable balloon 124 is secured around the catheter shaft 121. Balloon 124 includes an outer wall 123 and an inner wall 122, inner wall 122 being located within outer wall 123. The proximal ends of the inner wall 122 and the outer wall 123 are sealingly secured together about the catheter shaft 121, and the distal ends of the inner wall 122 and the outer wall 123 are sealingly secured together about the catheter shaft 121.

The balloon catheter also includes six mechanical waveguides 125 interposed between the inner wall 122 and the outer wall 123. The outer wall 123 has a circular cross-sectional shape, while the inner wall 122 defines six inwardly extending grooves, each shaped and sized to receive a corresponding mechanical waveguide 125. Each groove extends along a given longitudinal portion of balloon 124. The portion of the inner wall 122 located between two adjacent grooves is secured to the outer wall 123. For each groove, the outer wall 123 includes a proximal aperture and a distal aperture, each aligned with a corresponding groove, for insertion of a corresponding mechanical waveguide 125. Each groove and its corresponding proximal and distal holes in the outer wall 123 form a hole that extends through a given portion of the balloon 124. Each mechanical waveguide 125 is inserted into a corresponding hole, and the distal end of each mechanical waveguide 124 projects forward from the distal end of the hole, as shown in fig. 10.

In one embodiment, the mechanical waveguides 125 are securely fixed within their respective holes in the balloon 124 such that each mechanical waveguide 125 has a fixed position relative to the balloon 124. In another embodiment, the mechanical waveguides 125 are movably inserted into their respective holes through the balloon such that the position of the distal end of the mechanical waveguides 125 can be varied relative to the distal end of the catheter shaft 121.

It should be appreciated that the outer wall 123 may not include a distal aperture such that the distal end of each mechanical waveguide 125 is located within its respective hole. Alternatively, not all of the grooves are provided with corresponding distal holes in the outer wall 123, such that only the distal ends of some of the mechanical waveguides 125 may extend forward from the balloon 124.

It should be appreciated that fluid is inserted into the cavity formed between the inner wall 122 and the catheter shaft 121 to inflate/deflate the balloon 124. By controlling the pressure of the fluid within the cavity, the inflation and size of the balloon, and thus the position of the distal end of the mechanical waveguide 125 relative to the catheter shaft 121, can be controlled.

It should be appreciated that the number of mechanical waveguides 125 may vary so long as the balloon catheter includes at least one mechanical waveguide 125. Similarly, the number of holes within balloon 124 may also vary accordingly. The location on balloon 124, the shape and/or length of the holes within balloon 124 may also vary.

Fig. 11 and 12 illustrate an embodiment of a balloon catheter that includes a catheter shaft 131, the catheter shaft 131 having a tubular shape and extending between a proximal end and a distal end. The catheter shaft 131 is provided with a central bore or lumen 139 extending between the proximal and distal ends of the catheter shaft 131. An inflatable balloon 134 is secured around the catheter shaft 131. Balloon 134 includes an outer wall 133 and an inner wall 132, with inner wall 122 being located within outer wall 133. In embodiments where the lengths of the inner wall 132 and the outer wall 133 are substantially the same, the proximal ends of the inner wall 132 and the outer wall 133 are sealingly secured together about the catheter shaft 131, as are the distal ends of the inner wall 132 and the outer wall 133. Alternatively, the outer wall 133 may be shorter than the inner wall 132, and the distal and proximal ends of the outer wall may be secured to the outer surface of the inner wall 132, with only the proximal and distal ends of the inner wall 132 sealingly secured to the catheter shaft 131.

The balloon catheter also includes six mechanical waveguides 135 interposed between the inner wall 132 and the outer wall 133. The inner wall 133 has a circular cross-sectional shape, while the outer wall 133 defines six outwardly extending protrusions, each of which is shaped and dimensioned to receive a corresponding mechanical waveguide 135. Each projection extends along a given longitudinal portion of balloon 134. The portion of the outer wall 133 located between two adjacent protrusions is fixed to the inner wall 132. For each protrusion, the outer wall 133 includes a proximal aperture and a distal aperture, each aligned with a respective protrusion for insertion of a respective mechanical waveguide 135. Each protrusion in the outer wall 133 and its respective proximal and distal apertures form a hole that extends through a given portion of the balloon 134. Each mechanical waveguide 135 is inserted into a respective hole, and the distal end of each mechanical waveguide 134 projects forward from the distal end of the hole, as shown in fig. 12.

In one embodiment, the mechanical waveguides 135 are fixedly secured within their respective holes in the balloon 134 such that each mechanical waveguide 135 has a fixed position relative to the balloon 134. In another embodiment, the mechanical waveguides 135 are movably inserted into their respective holes through the balloon such that the position of the distal end of the mechanical waveguides 135 can be varied relative to the distal end of the catheter shaft 131.

It should be appreciated that the outer wall 133 may not include a distal aperture such that the distal end of each mechanical waveguide 135 is located within a corresponding hole within the balloon 134. Alternatively, not all of the grooves are provided with corresponding distal holes in the outer wall 133, such that only the distal ends of some of the mechanical waveguides 135 may extend forward from the balloon 134.

It should be appreciated that fluid is inserted into the cavity formed between the inner wall 132 and the catheter shaft 131 to inflate/deflate the balloon 134. By controlling the pressure of the fluid within the cavity, the inflation and size of the balloon 134, and thus the position of the distal end of the mechanical waveguide 135 relative to the catheter shaft 131, can be controlled.

It should be appreciated that the number of mechanical waveguides 135 may vary so long as the balloon catheter includes at least one mechanical waveguide 135. Similarly, the number of holes within balloon 134 may also vary accordingly. The location on balloon 134, the shape and/or length of the holes within balloon 134 may also vary.

Fig. 13 shows one embodiment of a balloon catheter 200 comprising a catheter shaft 201, a balloon 204 and two mechanical waveguides 205. The catheter shaft 201 extends between a proximal end 208 and a distal end 207 and includes an inner wall 212 and an outer wall 214 each having a tubular shape. The outer wall 214 includes a central hole into which the inner wall 212 is inserted while being firmly fixed to the outer wall 214. The distal end of the outer wall 214 is secured to the inner wall 212. Two mechanical waveguides 205 are inserted into the holes of the outer wall 214 between the inner surface of the outer wall 214 and the outer surface of the inner wall 212. The inner wall 212 also defines a bore extending between the proximal and distal ends of the catheter shaft 201. In one embodiment, the inner wall 212 is provided with an end wall at its distal end such that the aperture defined by the inner wall 212 does not extend through its distal end. In another embodiment, no end wall is provided at the distal end of the inner wall 212 such that the aperture extends through the distal end of the inner wall 212.

The outer wall 214 is provided with two holes, each sized and shaped for receiving a respective machine 205 therethrough, and allowing the mechanical waveguide 205 to be inserted from the space defined between the inner wall 212 and the outer wall 214 into the cavity existing between the balloon 204 and the outer wall 214 of the catheter shaft 201. In the illustrated embodiment, two holes through the outer wall 214 are located at a position 209 adjacent the proximal end of the balloon 204, with a portion of each mechanical waveguide 205 inserted into the balloon 204 in physical contact with the inner surface of the balloon 204. Each mechanical waveguide 204 is inserted into the balloon 204 such that its distal end is located at a given distance L from the distal end of the balloon 204.

In one embodiment, the distal end of the mechanical waveguide 205 has a fixed position relative to the distal end of the balloon 204 such that the distance L may not change. In this case, the distal end of the mechanical waveguide 205 may be firmly fixed to the inner surface of the balloon 204. In another embodiment, the distal end of the mechanical waveguide 205 has a movable position relative to the distal end of the balloon 204 such that the distance L may vary. In this case and for each mechanical waveguide 205, the balloon 204 may be provided with a ring or sheath secured to its inner surface, and wherein the mechanical waveguides are slidably inserted therein such that the mechanical waveguides 205 may slide along the inner surface of the balloon 204, the distal ends of the mechanical waveguides 205 being positionable at an appropriate distance L from the distal end of the balloon 204.

In one embodiment, each mechanical waveguide 205 is sealingly inserted into its corresponding aperture through the outer wall 214 such that fluid present in the balloon 204 may not flow into the space defined between the inner wall 212 and the outer wall 214 via the aperture into which the mechanical waveguide is inserted. For example, a sealing gasket may be inserted into the hole between the mechanical waveguide 205 and the outer wall 214. In one embodiment, the sealing gasket allows movement of the mechanical waveguide 205 relative to the outer wall 214.

In another embodiment, fluid may flow from balloon 204 into the space defined between inner wall 212 and outer wall 214 via an aperture into which a mechanical waveguide is inserted. For example, the size of the aperture may be larger than the size of the mechanical waveguide 205.

In one embodiment, the space defined between the inner and outer walls 212, 214 of the catheter shaft 201 and the mechanical waveguide 205 is used to inject fluid into the balloon 204 from the proximal end of the catheter shaft 201. In one embodiment, the mechanical waveguide may be unsealed secured to the outer wall 214 such that fluid may be inserted into the balloon 204 via a hole in the outer wall 214 into which the mechanical waveguide 205 is inserted. In another embodiment, the mechanical waveguides 205 may be sealingly inserted into their respective holes through the outer wall 214. In this case, the outer wall 214 is provided with at least one further aperture through which fluid may enter and exit the balloon 204. Fluid may be injected directly into the space defined between the inner and outer walls 212, 214 of the catheter shaft 201 and the mechanical waveguide 205. Alternatively, a tube connected to the fluid delivery system at its proximal end may be inserted in the space defined between the inner and outer walls 212, 214 of the catheter shaft 201 and the mechanical waveguide 205, the distal end of the tube being fluidly connected to the interior of the balloon 204 via a further aperture. In this embodiment, the distal end of the bore of the inner wall 212 may be open to allow for the use of a guidewire.

In another embodiment, the holes of the inner wall 212 are used to inject fluid into the balloon 204 and/or aspirate fluid from the balloon 204. In this case, the distal end of the bore of the inner wall 212 is hermetically closed. The inner wall 212 includes a first connection hole and the outer wall 214 includes a second connection hole. The connecting tube has a first end sealingly secured to the first connecting hole of the inner wall 212 and a second end sealingly secured to the second connecting hole of the outer wall 214 so as to fluidly connect the bore of the inner wall 212 to the interior space of the balloon. The proximal end of the bore of the inner wall 212 is fluidly connected to a fluid delivery system for injecting fluid into the balloon 204 and/or aspirating fluid from the balloon 204. In one embodiment, each mechanical waveguide 205 is sealingly inserted into its corresponding bore through the outer wall 214 such that no fluid can flow from the balloon 204 into the space defined between the inner wall 212 and outer wall 214 of the catheter shaft 201 and the mechanical waveguide 205.

In one embodiment, the catheter shaft 201 is also provided with two radiopaque markers 203 on the inner surface of the outer wall 214. The radiopaque markers are positioned such that each marker is located within the balloon 204 and adjacent to a respective end of the balloon 204. Radiopaque marker 203 is used as a reference marker to visualize the position of the end of balloon 204 and/or to indicate the extent of the length of balloon 204.

It should be appreciated that the diameter of the holes present in the outer wall 214 is selected to be at least equal to the sum of the outer diameter of the inner wall 212 and the diameter of the mechanical waveguide 205. In the illustrated embodiment, the diameter of the holes present in the outer wall 214 is at least equal to the outer diameter of the inner wall 212 plus twice the diameter of the mechanical waveguide 209.

In one embodiment, the distal tip portion 202 of the catheter shaft 201 is located near the distal end 207 thereof. Within the distal tip portion 202, the diameter of the outer wall 214 decreases toward the distal end 207 of the catheter shaft 201 such that the inner diameter of the outer wall 214 is equal to the outer diameter of the inner wall at the distal end 207 of the catheter shaft 201.

Fig. 14 shows one embodiment of a balloon catheter 300 comprising a catheter shaft 301, a balloon 304 and two mechanical waveguides 305. The catheter shaft 301 extends between a proximal end 308 and a distal end 307 and includes an inner wall 312 and an outer wall 314 each having a tubular shape. The outer wall 314 includes a central hole into which the inner wall 312 is inserted while being firmly fixed to the outer wall 314. The distal end of the outer wall 314 is secured to the inner wall 312. Two mechanical waveguides 305 are inserted into the holes of the outer wall 314 between the inner surface of the outer wall 314 and the outer surface of the inner wall 312. The inner wall 312 also defines a bore extending between the proximal and distal ends of the catheter shaft 301. In one embodiment, the inner wall 312 is provided with an end wall at its distal end such that the aperture defined by the inner wall 312 does not extend through its distal end. In another embodiment, no end wall is provided at the distal end of the inner wall 312 such that the aperture extends through the distal end of the inner wall 312.

The outer wall 314 is provided with two holes, each sized and shaped to receive a respective machine 305 therethrough and to allow the mechanical waveguide 305 to be inserted from the space defined between the inner wall 312 and the outer wall 314 into the cavity existing between the balloon 304 and the outer wall 314 of the catheter shaft 301. In the illustrated embodiment, two holes through outer wall 314 are located at a position 309 distal from the proximal end of balloon 304, and mechanical waveguides 305 each emerge outwardly from their respective holes toward the wall of balloon 304. The mechanical waveguides 305 are positioned within the balloon 304 such that their distal ends are proximate to the inner surface of the balloon 304 at a connection point 306 and at a given distance L from the distal end of the balloon 304.

In one embodiment, the distal end of the mechanical waveguide 305 has a fixed position relative to the distal end of the balloon 304 such that the distance L may not change. In this case, the distal end of the mechanical waveguide 305 may be firmly fixed to the inner surface of the balloon 304. In another embodiment, the distal end of the mechanical waveguide 305 has a movable position relative to the distal end of the balloon 304 such that the distance L may vary. In this case, the curvature of the portion of the mechanical waveguide inserted into the balloon 304 may be changed so as to change the position of the contact point between the distal end of the mechanical waveguide 305 and the inner surface of the balloon 304.

In one embodiment, each mechanical waveguide 305 is sealingly inserted into its corresponding aperture through the outer wall 314 such that fluid present in the balloon 304 may not flow into the space defined between the inner wall 312 and the outer wall 314 via the aperture into which the mechanical waveguide 305 is inserted. For example, a sealing gasket may be inserted into the hole between the mechanical waveguide 305 and the outer wall 314. In one embodiment, the sealing gasket allows movement of the mechanical waveguide 305 relative to the outer wall 314.

In another embodiment, fluid may flow from balloon 304 into the space defined between inner wall 312 and outer wall 314 via an aperture into which a mechanical waveguide is inserted. For example, the size of the holes may be larger than the size of the mechanical waveguide 305.

In one embodiment, the space defined between the inner and outer walls 312, 314 of the catheter shaft 301 and the mechanical waveguide 305 is used to inject fluid into the balloon 304 from the proximal end of the catheter shaft 301. In one embodiment, the mechanical waveguide may be unsealed secured to the outer wall 314 such that fluid may be inserted into the balloon 304 via a hole in the outer wall 314 into which the mechanical waveguide 305 is inserted. In another embodiment, the mechanical waveguides 305 may be sealingly inserted into their corresponding holes through the outer wall 314. In this case, the outer wall 314 is provided with at least one additional aperture through which fluid may enter and exit the balloon 304. The fluid may be injected directly into the space defined between the inner and outer walls 312, 314 of the catheter shaft 301 and the mechanical waveguide 305. Alternatively, a tube connected to the fluid delivery system at its proximal end may be inserted in the space defined between the inner and outer walls 312, 314 of the catheter shaft 301 and the mechanical waveguide 305, the distal end of the tube being fluidly connected to the interior of the balloon 304 via a further aperture. In this embodiment, the distal end of the bore of the inner wall 312 may be open to allow for the use of a guidewire.

In another embodiment, the holes of the inner wall 312 are used to inject fluid into the balloon 304 and/or aspirate fluid from the balloon 304. In this case, the distal end of the bore of the inner wall 312 is hermetically closed. The inner wall 312 includes a first connection hole and the outer wall 314 includes a second connection hole. The connecting tube has a first end sealingly secured to the first connecting hole of the inner wall 312 and a second end sealingly secured to the second connecting hole of the outer wall 314 so as to fluidly connect the bore of the inner wall 312 to the interior space of the balloon. The proximal end of the bore of the inner wall 312 is fluidly connected to a fluid delivery system for injecting fluid into the balloon 304 and/or aspirating fluid from the balloon 304. In one embodiment, each mechanical waveguide 305 is sealingly inserted into its corresponding bore through the outer wall 314 such that no fluid can flow from the balloon 304 into the space defined between the inner and outer walls 312, 314 of the catheter shaft 301 and the mechanical waveguide 305.

In one embodiment, the catheter shaft 301 is also provided with two radiopaque markers 303 on the inner surface of the outer wall 314. The radiopaque markers are positioned such that each marker is located within the balloon 304 and adjacent to a respective end of the balloon 304. Radiopaque marker 303 is used as a reference marker to visualize the position of the end of balloon 304 and/or to indicate the extent of the length of balloon 304.

It should be appreciated that the diameter of the holes present in the outer wall 314 is selected to be at least equal to the sum of the outer diameter of the inner wall 312 and the diameter of the mechanical waveguide 309. In the illustrated embodiment, the diameter of the holes present in the outer wall 314 is at least equal to the outer diameter of the inner wall 312 plus twice the diameter of the mechanical waveguide 309.

In one embodiment, the distal tip portion 302 of the catheter shaft 301 is located near its distal end 307. Within the distal tip portion 302, the diameter of the outer wall 314 decreases toward the distal end 307 of the catheter shaft 301 such that the inner diameter of the outer wall 314 is equal to the outer diameter of the inner wall at the distal end 307 of the catheter shaft 301.

Fig. 15 shows one embodiment of a balloon catheter 400 comprising a catheter shaft 401, a balloon 404, and two mechanical waveguides 405. The catheter shaft 401 extends between the proximal end 408 and the distal end 407 and includes an inner wall 412 and an outer wall 414 each having a tubular shape. The outer wall 414 includes a central aperture into which the inner wall 412 is inserted while being fixedly secured to the outer wall 414. The distal end of the outer wall 414 is secured to the inner wall 412. Two mechanical waveguides 405 are inserted into the holes of the outer wall 414 between the inner surface of the outer wall 414 and the outer surface of the inner wall 412. The inner wall 412 also defines a bore extending between the proximal and distal ends of the catheter shaft 401. In one embodiment, the inner wall 412 is provided with an end wall at its distal end such that the aperture defined by the inner wall 412 does not extend through its distal end. In another embodiment, no end wall is provided at the distal end of the inner wall 412 such that the aperture extends through the distal end of the inner wall 412.

The outer wall 414 is provided with two holes, each sized and shaped to receive a respective machine 405 therethrough, and to allow the mechanical waveguide 405 to be inserted into the cavity existing between the balloon 404 and the outer wall 414 of the catheter shaft 401 from the space defined between the inner wall 412 and the outer wall 414. In the illustrated embodiment, two holes through the outer wall 414 are each located at a position 409 away from the proximal end of the balloon 404, and the mechanical waveguides 405 are each presented outwardly from their respective holes toward the wall of the balloon 404. The portion of the mechanical waveguide 405 adjacent its distal end 406 is curved. The mechanical waveguides 405 are positioned within the balloon 404 such that their distal ends 406 are free within the balloon 404.

In one embodiment, the distal end of the mechanical waveguide 405 has a fixed position relative to the distal end of the balloon 404. In this case, the distal end of the mechanical waveguide 405 may be fixedly secured to the inner surface of the balloon 404. In another embodiment, the distal end of the mechanical waveguide 405 has a movable position within the balloon 404.

In one embodiment, each mechanical waveguide 405 is sealingly inserted into its corresponding aperture through the outer wall 414 such that fluid present in the balloon 404 may not flow into the space defined between the inner wall 412 and the outer wall 414 via the aperture into which the mechanical waveguide 405 is inserted. For example, a sealing gasket may be inserted into the hole between the mechanical waveguide 405 and the outer wall 414. In one embodiment, the sealing gasket allows movement of the mechanical waveguide 405 relative to the outer wall 414.

In another embodiment, fluid may flow from the balloon 404 into the space defined between the inner wall 412 and the outer wall 414 via an aperture into which a mechanical waveguide is inserted. For example, the size of the holes in the outer wall 414 may be larger than the size of the holes of the mechanical waveguide 405.

In one embodiment, the space defined between the inner and outer walls 412, 414 of the catheter shaft 401 and the mechanical waveguide 405 is used to inject fluid into the balloon 404 from the proximal end of the catheter shaft 401. In one embodiment, the mechanical waveguide may be unsealed secured to the outer wall 414 such that fluid may be inserted into the balloon 404 via a hole in the outer wall 414 into which the mechanical waveguide 405 is inserted. In another embodiment, the mechanical waveguides 405 may be sealingly inserted into their corresponding holes through the outer wall 414. In this case, the outer wall 414 is provided with at least one additional aperture through which fluid may enter and exit the balloon 404. Fluid may be injected directly into the space defined between the inner 412 and outer 414 walls of the catheter shaft 401 and the mechanical waveguide 405. Alternatively, a tube connected to the fluid delivery system at its proximal end may be inserted into the space defined between the inner and outer walls 412, 414 of the catheter shaft 401 and the mechanical waveguide 405, and the distal end of the tube fluidly connected to the interior of the balloon 404 via additional holes. In this embodiment, the distal end of the bore of the inner wall 412 may be open to allow for the use of a guidewire.

In another embodiment, the longitudinal bore of the inner wall 412 is used to inject fluid into the balloon 404 and/or aspirate fluid from the balloon 404. In this case, the distal end of the longitudinal bore of the inner wall 412 is hermetically closed. The inner wall 412 includes a first connection hole and the outer wall 414 includes a second connection hole. The connecting tube has a first end sealingly secured to the first connecting hole of the inner wall 412 and a second end sealingly secured to the second connecting hole of the outer wall 414 so as to fluidly connect the bore of the inner wall 412 to the interior space of the balloon. The proximal end of the bore of the inner wall 412 is fluidly connected to a fluid delivery system for injecting fluid into the balloon 404 and/or aspirating fluid from the balloon 404. In one embodiment, each mechanical waveguide 405 is sealingly inserted into its corresponding hole through the outer wall 414 such that no fluid can flow from the balloon 404 into the space defined between the inner and outer walls 412, 414 of the catheter shaft 401 and the mechanical waveguide 405.

In one embodiment, the catheter shaft 401 is also provided with two radiopaque markers 403 on the inner surface of the outer wall 414. The radiopaque markers are positioned such that each marker is located within the balloon 404 and adjacent to a respective end of the balloon 404. The radiopaque markers 403 are used as reference markers to visualize the position of the end of the balloon 404 and/or to indicate the extent of the length of the balloon 404.

It should be appreciated that the diameter of the holes present in the outer wall 414 is selected to be at least equal to the sum of the outer diameter of the inner wall 412 and the diameter of the mechanical waveguide 409. In the illustrated embodiment, the diameter of the holes present in the outer wall 414 is at least equal to the outer diameter of the inner wall 412 plus twice the diameter of the mechanical waveguide 409.

In one embodiment, the distal tip portion 402 of the catheter shaft 401 is located near its distal end 407. Within the distal tip portion 402, the diameter of the outer wall 414 decreases toward the distal end 407 of the catheter shaft 401 such that the inner diameter of the outer wall 414 is equal to the outer diameter of the inner wall at the distal end 407 of the catheter shaft 401.

Fig. 21 shows one embodiment of a balloon catheter 500 comprising a catheter shaft 501, a balloon 504 and two mechanical waveguides 505. The catheter shaft 501 extends between the proximal end 508 and the distal end 507 and includes an inner wall 512 and an outer wall 514 each having a tubular shape. The outer wall 514 includes a central aperture into which the inner wall 512 is inserted while being fixedly secured to the outer wall 514. The distal end of outer wall 514 is secured to inner wall 512. Two mechanical waveguides 505 are inserted into the holes of outer wall 514 between the inner surface of outer wall 514 and the outer surface of inner wall 512. The inner wall 512 also defines a bore extending between the proximal and distal ends of the catheter shaft 501. In one embodiment, the inner wall 512 is provided with an end wall at its distal end such that the aperture defined by the inner wall 512 does not extend through its distal end. In another embodiment, no end wall is provided at the distal end of the inner wall 512 such that the aperture extends through the distal end of the inner wall 512.

The outer wall 514 is provided with two holes, each sized and shaped to receive a respective machine 505 therethrough and to allow the mechanical waveguide 505 to be inserted from the space defined between the inner wall 512 and the outer wall 514 into the cavity existing between the balloon 504 and the outer wall 514 of the catheter shaft 501. In the illustrated embodiment, two holes through outer wall 514 are located at a location 509 distal from the proximal end of balloon 504, and mechanical waveguides 505 each appear outwardly from their respective holes toward the wall of balloon 504. The mechanical waveguide 505 is positioned inside the balloon 504 such that a distal portion of the mechanical waveguide 505 adjacent its distal end 506 extends along and is adjacent to an outer surface of the outer wall 514 of the catheter shaft 501. In one embodiment, the distal portion of the mechanical waveguide may be secured to the outer wall 514 of the catheter shaft 501.

In one embodiment, the distal end of the mechanical waveguide 505 has a fixed position relative to the distal end of the balloon 504 such that the distance L between the distal end 506 of the mechanical waveguide 505 and the distal end of the balloon 504 may be constant. In this case, the distal end of the mechanical waveguide 505 may be firmly fixed to the outer surface of the outer wall 514. In another embodiment, the distal end 506 of the mechanical waveguide 505 has a movable position relative to the distal end of the balloon 504 such that the distance L may vary.

In one embodiment, each mechanical waveguide 505 is sealingly inserted into its corresponding aperture through outer wall 514 such that fluid present in balloon 504 may not flow into the space defined between inner wall 512 and outer wall 514 via the aperture into which mechanical waveguide 505 is inserted. For example, a sealing gasket may be inserted into the hole between the mechanical waveguide 505 and the outer wall 514. In one embodiment, the sealing gasket allows movement of the mechanical waveguide 505 relative to the outer wall 514.

In another embodiment, fluid may flow from balloon 504 into the space defined between inner wall 512 and outer wall 514 via an aperture into which a mechanical waveguide is inserted. For example, the size of the aperture may be greater than the size of the mechanical waveguide 505.

In one embodiment, the space defined between the inner and outer walls 512, 514 of the catheter shaft 501 and the mechanical waveguide 505 is used to inject fluid into the balloon 504 from the proximal end of the catheter shaft 501. In one embodiment, the mechanical waveguide may be unsealed secured to the outer wall 514 such that fluid may be inserted into the balloon 504 via a hole of the outer wall 514 into which the mechanical waveguide 505 is inserted. In another embodiment, mechanical waveguides 505 may be sealingly inserted into their corresponding holes through outer wall 514. In this case, outer wall 514 is provided with at least one additional aperture through which fluid may enter and exit balloon 504. Fluid may be injected directly into the space defined between the inner 512 and outer 514 walls of the catheter shaft 501 and the mechanical waveguide 505. Alternatively, a tube connected to the fluid delivery system at its proximal end may be inserted into the space defined between the inner and outer walls 512, 514 of the catheter shaft 501 and the mechanical waveguide 505, and the distal end of the tube fluidly connected to the interior of the balloon 504 via additional holes. In this embodiment, the distal end of the bore of the inner wall 512 may be open to allow for the use of a guidewire.

In another embodiment, the holes of the inner wall 512 are used to inject fluid into the balloon 504 and/or aspirate fluid from the balloon 504. In this case, the distal end of the bore of the inner wall 512 is hermetically closed. Inner wall 512 includes a first connection hole and outer wall 514 includes a second connection hole. The connecting tube has a first end sealingly secured to the first connecting hole of the inner wall 512 and a second end sealingly secured to the second connecting hole of the outer wall 514 so as to fluidly connect the bore of the inner wall 512 to the interior space of the balloon. The proximal end of the bore of the inner wall 512 is fluidly connected to a fluid delivery system for injecting fluid into the balloon 504 and/or aspirating fluid from the balloon 504. In one embodiment, each mechanical waveguide 505 is sealingly inserted into its corresponding hole through outer wall 514 such that no fluid can flow from balloon 504 into the space defined between inner wall 512 and outer wall 514 of catheter shaft 501 and mechanical waveguide 505.

In one embodiment, the catheter shaft 501 is also provided with two radiopaque markers 503 on the inner surface of the outer wall 514. The radiopaque markers are positioned such that each marker is located within the balloon 504 and adjacent to a respective end of the balloon 504. Radiopaque marker 503 is used as a reference marker to visualize the position of the end of balloon 504 and/or to indicate the extent of the length of balloon 504.

It should be appreciated that the diameter of the holes present in the outer wall 514 is selected to be at least equal to the sum of the outer diameter of the inner wall 512 and the diameter of the mechanical waveguide 509. In the illustrated embodiment, the diameter of the holes present in outer wall 514 is at least equal to the outer diameter of inner wall 512 plus twice the diameter of mechanical waveguide 509.

In one embodiment, the distal tip portion 502 of the catheter shaft 501 is located near its distal end 507. Within distal tip portion 502, the diameter of outer wall 514 decreases toward distal end 507 of catheter shaft 501 such that the inner diameter of outer wall 514 is equal to the outer diameter of the inner wall at distal end 507 of catheter shaft 501.

It should be appreciated that the distal ends of the mechanical waveguides 205, 305, 405 and 505 are operably connected to a source of mechanical waves and/or pulses.

Fig. 16 and 17 illustrate various tip geometries of a mechanical waveguide disposed on an outer surface of a balloon catheter for deflecting and/or directing mechanical waves emitted by the mechanical waveguide. The embodiment shown in fig. 16 and 17 may be used in combination with the embodiment shown in fig. 11 and 12.

Fig. 16 shows a mechanical waveguide 145 disposed on an outer surface 143 of the balloon. The distal tip 146 of the mechanical waveguide 145 is bent outwardly. It should be appreciated that the curvature of the tip 146 of the mechanical waveguide 145 may be selected according to the desired energy deposition mode.

Fig. 17 illustrates one embodiment of a balloon catheter that includes a deflection device to deflect, reflect, and/or orient mechanical waves emitted by a mechanical waveguide. The mechanical waveguide 155 is secured to the outer surface 153 of the balloon 152 and a deflector 158 is also secured to the outer surface of the balloon so as to face the distal end 156 of the mechanical waveguide 155 to deflect, reflect and/or orient the mechanical waves emitted by the mechanical waveguide 155 according to a desired orientation. It should be appreciated that any suitable means for deflecting or reflecting the mechanical wave may be used. In one embodiment, the deflector 158 is adjustable such that the deflection or reflection orientation and/or the distance between the distal tip 156 of the mechanical waveguide 155 and the proximal end 157 of the deflector 158 may be adjusted to correspond to a desired direction to propagate mechanical waves propagating from the distal end 156 of the mechanical waveguide 155 in the desired direction. For example, the distal end 156 of the mechanical waveguide 155 may be positioned to emit mechanical waves in the direction of the longitudinal axis of the catheter, and the deflector 158 may redirect the mechanical waves in a radial direction, i.e., in a direction substantially orthogonal to the longitudinal axis. In one embodiment, the deflector 158 may be covered by a sheath made of acoustically coupled material. It should be appreciated that the number, location, shape and size of the deflectors may be selected according to the desired energy deposition pattern of the balloon catheter device.

Fig. 18, 19 and 20 illustrate various mechanical waveguide tip geometries of mechanical waveguides disposed on the inner surface of a balloon for deflecting and/or directing mechanical waves emitted by the mechanical waveguides. The embodiments shown in figures 18, 19 and 20 may be used in combination with the embodiments shown in figures 9 and 10.

Fig. 18 shows a mechanical waveguide 165 disposed on the inner surface 162 of the balloon. The balloon is provided with a hole through which the outwardly curved distal tip 166 of the mechanical waveguide 165 is sealingly inserted. In one embodiment, the distal tip 166 of the mechanical waveguide 165 is presented flush with the outer surface 163 of the mechanical waveguide 165. In another embodiment, the distal tip 166 of the mechanical waveguide 165 is presented outside of the outer surface 163 of the balloon.

Fig. 19 illustrates one embodiment of a balloon catheter that includes a deflection device to deflect, reflect, and/or orient mechanical waves emitted by a mechanical waveguide. The balloon catheter includes a balloon 173 and a mechanical waveguide 175, the mechanical waveguide 175 being located on an inner surface 172 of the balloon 173. The balloon catheter also includes a deflector 178 positioned facing the distal end 176 of the mechanical waveguide 175 to deflect, reflect and/or orient mechanical waves emitted by the mechanical waveguide 175 according to a desired orientation. It should be appreciated that any suitable means for deflecting or reflecting the mechanical wave may be used. In one embodiment, the deflector 178 is adjustable such that the deflection or reflection orientation and/or the distance between the distal tip 176 of the mechanical waveguide 175 and the proximal end 177 of the deflector 178 can be adjusted to correspond to a desired direction to propagate mechanical waves propagating from the distal end of the mechanical waveguide in the desired direction. For example, the distal end 176 of the mechanical waveguide 175 may be positioned to emit mechanical waves in the direction of the longitudinal axis of the catheter, and the deflector 178 may redirect the mechanical waves in a radial direction, i.e., in a direction substantially orthogonal to the longitudinal axis. It should be appreciated that the number, location, shape and size of the deflectors may be selected according to the desired energy deposition pattern of the balloon catheter device.

Fig. 20 shows a mechanical waveguide 185 disposed on the inner surface 182 of the balloon 183. The portion of the mechanical waveguide 185 adjacent the distal tip 186 is bent outwardly such that the distal tip 186 abuts the inner surface 182 of the balloon 183.

In one embodiment, the outer surface of the balloon or sheath (if any) may be coated with a drug (or the like) that may diffuse into the surrounding tissue before, during, or after the emission of mechanical waves from the mechanical waveguide. In one embodiment, mechanical wave emissions from the mechanical waveguide may promote more efficient drug uptake from surrounding tissue.

In one embodiment, the balloon catheter may comprise a double-walled balloon, and the space between the two walls of the balloon may contain a drug (or the like). Delivery of the drug may be triggered from the proximal end of the balloon catheter device, with the mechanism traveling along the length of the device. Delivery of the drug may also be triggered by mechanical wave emissions at the distal end of the balloon catheter.

In one embodiment, the balloon catheter device further comprises one or more fluid (i.e., liquid and/or gas) delivery tubes to deliver a fluid containing a drug, vaccine, or other therapeutic substance to the lesion to be treated. Also in another embodiment, for example, a delivery tube may be used to deliver fluid to cool/heat the lesion to be treated. The fluid delivery may be performed before, simultaneously with, or after the mechanical energy exposure. In another embodiment, the tube may be used to aspirate debris resulting from the treatment.

In one embodiment, the balloon catheter may include a drug (or similar) capsule at its distal end that may be triggered (released) from its proximal end using a mechanism that travels along the length of the device.

In one embodiment, a drug (or similar) capsule may be located at the distal end of the balloon catheter, and the capsule may be triggered (released) by mechanical wave emissions at the distal end of the balloon catheter.

In one embodiment, the balloon catheter further comprises an Optical Coherence Tomography (OCT) or intravascular ultrasound (IVUS) imaging device between the inner catheter and the outer surface of the balloon.

In one embodiment, the balloon catheter may be covered with a hydrophilic, hydrophobic, or friction reducing coating, or a combination thereof.

In one embodiment, the balloon catheters and methods described above may be used to treat calcification and fibrotic lesions while minimizing arterial wall tissue damage and embolic size.

It should be appreciated that the balloon may have any suitable shape. For example, the shape of the inflation balloon may be substantially cylindrical.

The embodiments of the invention described above are intended to be exemplary only. Accordingly, the scope of the invention is intended to be limited only by the scope of the appended claims.

Claims

1. An apparatus for delivering high amplitude and short duration mechanical pulses to treat a lesion present in a blood vessel, comprising:

A catheter body extending along a longitudinal axis between a first proximal end and a first distal end;

an inflatable balloon secured to the catheter body and adjustable between an inflated configuration and a deflated configuration, the inflatable balloon being fluidly connectable to a fluid source to change the configuration of the balloon; and

at least one mechanical waveguide extending between a second proximal end and a second distal end operatively connected to a source of high amplitude and short duration mechanical pulses for propagating high amplitude and short duration mechanical pulses from the second proximal end to the second distal end for treating the lesion, the at least one mechanical waveguide being secured to at least a portion of the catheter body between the first proximal end and the first distal end of the catheter body,

wherein the high amplitude of the mechanical pulse at the second distal end is between 10MPa and 1000MPa and the short duration at the second distal end is 1/fc, said fc being a center frequency between 20kHz and 10 MHz.

2. The device of claim 1, wherein the at least one mechanical waveguide is secured to one of an outer surface and an inner surface of the inflatable balloon.

3. The device of claim 2, wherein the second distal end of the at least one mechanical waveguide is coplanar with the first distal end of the catheter body when the inflatable balloon is inflated.

4. The device of claim 2, wherein the second distal end of the at least one mechanical waveguide protrudes from the first distal end of the catheter body when the inflatable balloon is inflated.

5. The device of claim 2, wherein the second distal end of the at least one mechanical waveguide is located between a proximal end and a distal end of the catheter body when the inflatable balloon is inflated.

6. The device of claim 2, wherein the at least one mechanical waveguide is movably secured to one of the outer and inner surfaces of the inflatable balloon.

7. The apparatus of claim 2, further comprising at least one deflector facing the second distal end of a respective one of the at least one mechanical waveguides, and wherein at least one deflector is adapted to deflect mechanical pulses radially.

8. The device of claim 1, wherein at least a portion of the at least one mechanical waveguide is inserted within the inflatable balloon.

9. The device of claim 8, wherein the balloon comprises an inner wall facing the catheter body, and an outer wall comprising at least one aperture on a distal face thereof, the at least one mechanical waveguide extending at least partially between the inner wall and the outer wall, each mechanical waveguide passing through a respective one of the at least one aperture.

10. The apparatus of claim 9, wherein the inner wall has a substantially circular cross-sectional shape and the outer wall defines at least one protrusion, each protrusion receiving a respective one of the at least one mechanical waveguide.

11. The apparatus of claim 9, wherein the outer wall has a substantially circular cross-sectional shape and the inner wall defines at least one groove, each groove receiving a respective one of the at least one mechanical waveguide.

12. The device of claim 8, wherein the catheter body comprises an inner wall and an outer wall spaced apart from the inner wall, the at least one mechanical waveguide interposed between the inner wall and the outer wall, the outer wall comprising at least one aperture, the at least one mechanical waveguide interposed in a respective one of the at least one aperture so as to extend partially within the inflatable balloon.

13. The apparatus of claim 12, wherein the at least one mechanical waveguide is sealingly inserted into a respective one of the at least one aperture.

14. The device of claim 12, wherein the second distal end of the at least one mechanical waveguide is positioned within the inflatable balloon.

15. The apparatus of claim 14, further comprising at least one deflector facing the second distal end of a respective one of the at least one mechanical waveguide.

16. The device of claim 12, wherein the inflatable balloon comprises at least one hole, and the second distal end of the at least one mechanical waveguide is sealingly inserted into a respective one of the at least one hole.

17. The device of claim 16, wherein the second distal end of the at least one mechanical waveguide protrudes outside of the inflatable balloon.

18. The apparatus of claim 1, wherein the at least one mechanical waveguide comprises a plurality of mechanical waveguides.

19. The device of claim 18, wherein the mechanical waveguides are arranged according to at least two rows when the inflatable balloon is in the deflated configuration, and the mechanical waveguides are arranged according to a single row when the inflatable balloon is in the inflated configuration.

20. The apparatus of claim 1, further comprising at least one waveguide, wherein a respective one of the at least one mechanical waveguide is inserted.

21. The device of claim 1, wherein an outer surface of the inflatable balloon is coated with one of: drugs, hydrophilic coatings, hydrophobic coatings, and friction reducing coatings.

22. The device of claim 1, wherein a distal tip at a second distal end of the at least one mechanical waveguide is not secured to the catheter body and the inflatable balloon.