JPWO2019111239A5 - - Google Patents

Description

The present invention relates to the field of medical devices, and in particular to medical devices and systems that use mechanical waves such as ultrasound and shock waves to perform medical treatments on cells, tissues and/or organs.

BACKGROUND Non-invasive treatments using ultrasound or shock waves are commonly used to treat a variety of diseases such as kidney stones and prostate cancer. They are attractive because the source of the mechanical waves is external to the body of the patient being treated, so the procedure can be considered non-invasive. By properly designing the mechanical energy source, the mechanical waves can typically be focused on a therapeutic target within the body. However, this technique has limitations. For example, obtaining the precise location of the therapeutic target can be difficult due to the limitations of the imaging methods used. Also, the energy may not be precisely focused to the desired target location due to the physical limitations of the converging waves themselves and the heterogeneity within the various tissues and organs to which the waves propagate. In a further example, the energy density at the target may not be sufficient to achieve the desired treatment.

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

SUMMARY According to a first broad aspect, there is provided a system for transmitting mechanical waves to treat lesions existing within blood vessels of a body, said system generating mechanical waves from outside said body. and a wave directing device insertable into the vessel, the wave directing device receiving the mechanical wave generated by the external mechanical wave source and directing the mechanical wave according to a target direction. It is for turning a wave.

In one embodiment, the wave directing device is adapted to reflect and focus the mechanical waves received from the external mechanical wave source.

In one embodiment, the wave director comprises at least one portion having one of a concave shape, a hemispherical shape and a parabolic shape.

In one embodiment, the wave directing device is one of composed of and coated with a reflective material having an acoustic impedance greater than that of water.

In one embodiment, the wave directing device comprises an acoustic mirror.
In another embodiment, said wave directing device is adapted to refract said mechanical waves received from said external mechanical wave source.

In one embodiment, the wave direction device is constructed of a material having an acoustic impedance different from that of water.

In one embodiment, the wave directing device comprises an acoustic lens.
In one embodiment, the wave directing device comprises at least one marker visible on the medical image.

In one embodiment, the markers are composed of a radiopaque material.
In one embodiment, the radiopaque material comprises one of platinum, gold, tungsten, combinations thereof, and a polymer doped with one of the platinum, gold and tungsten.

In one embodiment, the wave-directing device comprises an inflatable balloon, and the system further comprises injecting a fluid into the inflatable balloon to change the shape of the balloon. A fluid source is fluidly connected.

In one embodiment, the inflatable balloon is adapted to act as an acoustic lens.

In one embodiment, the inflatable balloon is adapted to act as an acoustic mirror.

In one embodiment, the system further comprises an elongated member, and the wave director is secured to the elongated member.

In one embodiment, the wave director is removably secured to the elongated member.
In another embodiment, the wave director is integral with the elongated member.

In one embodiment, the elongate member comprises one of a balloon and a catheter.

In one embodiment, the system further comprises a position tracking device for tracking at least one of the position and orientation of the wave -directing device once the wave-directing device is inserted into the vessel of the body.

In one embodiment, the position tracking device comprises one of an X-ray imager and an ultrasound imager.

In another embodiment, said position tracking device comprises a mechanical wave detector for detecting mechanical waves reflected by said wave directing device, wherein said position and said orientation of said wave directing device are The at least one is determined according to at least one of amplitude, phase and delay of mechanical waves detected by the mechanical wave detector.

In one embodiment, the wave directing device comprises a mechanical resonant structure for storing mechanical energy.

In one embodiment, the mechanical resonant structure comprises an inertial device and a compliant device.

In one embodiment, the wave directing device comprises at least one tube for one of sucking debris and delivering liquid.

In one embodiment, the wave directing device comprises a piezoelectric element for generating electricity.
According to another broad aspect, a method is provided for treating a lesion, the method comprising inserting a wave-directing device into a body vessel, the vessel comprising a lesion to be treated, the method comprising: Positioning the wave directing device adjacent to the lesion to be treated; generating mechanical waves using an external mechanical wave source located outside the body; propagating toward a wave-directing device; and redirecting and focusing the mechanical wave at the wave-directing device to the lesion to be treated.

In one embodiment, the step of redirecting the mechanical wave comprises reflecting the mechanical wave, wherein the wave directing device reflects the mechanical wave received from the external mechanical wave source. adapted to focus on

In one embodiment, the wave director comprises at least one portion having one of a concave shape, a hemispherical shape and a parabolic shape.

In one embodiment, the wave directing device is one of composed of and coated with a reflective material having an acoustic impedance greater than that of water.

In one embodiment, the wave directing device comprises an acoustic mirror.
In another embodiment, the step of redirecting the mechanical wave comprises refracting the mechanical wave, the wave directing device directing the mechanical wave received from the external mechanical wave source. adapted to be refracted and focused.

In one embodiment, the wave direction device is constructed of a material having an acoustic impedance different from that of water.

In one embodiment, the wave directing device comprises an acoustic lens.
In one embodiment, the wave directing device comprises at least one marker visible on the medical image.

In one embodiment, the markers are composed of a radiopaque material.
In one embodiment, the radiopaque material comprises one of platinum, gold, tungsten, combinations thereof, and a polymer doped with one of the platinum, gold and tungsten.

In one embodiment, the wave directing device comprises an inflatable balloon and the method further comprises inflating and deflating the balloon to obtain a desired shape of the balloon prior to generating the mechanical wave. provide one of the things to do.

In one embodiment, the inflatable balloon is adapted to act as an acoustic lens.

In another embodiment, the inflatable balloon is adapted to act as an acoustic mirror.

In one embodiment, the wave-directing device is secured to an elongated member and positioning the wave-directing device comprises manipulating a proximal end of the elongated member.

In one embodiment, the wave director is removably secured to the elongated member.
In another embodiment, the wave director is integral with the elongated member.

In one embodiment, the elongate member comprises one of a balloon and a catheter.

In one embodiment, the method further comprises using a position tracking device to detect at least one of the position and orientation of the wave-directing device once the wave- directing device is inserted into the blood vessel.

In one embodiment, the position tracking device comprises one of an X-ray imager and an ultrasound imager.

In one embodiment, detecting the position and/or orientation of the wave direction device includes detecting mechanical waves reflected by the wave direction device with a mechanical wave detector; determining said at least one of said position and said orientation from at least one of amplitude, phase and delay of mechanical waves detected by said mechanical wave detector.

In one embodiment, the wave directing device comprises a mechanical resonant structure for storing mechanical energy.

In one embodiment, the mechanical resonant structure comprises an inertial device and a compliant device.

In one embodiment, the wave directing device comprises at least one tube for one of sucking debris and delivering liquid.

In one embodiment, the wave directing device comprises a piezoelectric element for generating electricity.
As used herein, a mechanical wave should be understood to be a signal of arbitrary amplitude, duration, waveform, frequency, and/or other. For example, mechanical waves can have high/low amplitude, short/long duration, different waveforms, and arbitrary frequency content.

A mechanical pulse is here to be understood as a mechanical wave of short duration. The mechanical pulse duration is approximately 1/fc.

In one embodiment, the mechanical pulse has a center frequency fc comprised between about 20 kHz and about 10 MHz. In one embodiment, the amplitude of the mechanical pulse as it reaches the distal end of the catheter device is comprised between about 10 MPa and about 1000 MPa and a. In one embodiment, the duration of the mechanical pulse as it reaches the distal end of the catheter device is approximately 1/fc.

In one embodiment, the amplitude of the mechanical pulse as it reaches the distal end of the catheter device is comprised between about 1 MPa and about 1000 MPa. In one embodiment, the amplitude of the mechanical pulse as it reaches the distal end of the catheter device is comprised between about 10 MPa and about 1000 MPa.

A shock wave is defined as a mechanical pulse having a short duration, ie, on the order of microseconds or less, and a high amplitude, ie, an amplitude of at least 1 MPa when it reaches the distal end of the catheter device.

Further features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings.

A mechanical wave source for externally generating a mechanical wave and wave redirecting for redirecting the generated mechanical wave toward a lesion to be treated within a blood vessel of the body, according to one embodiment 1 is a block diagram showing a system including an apparatus; FIG. A mechanical wave source for externally generating a mechanical wave and a wave for reflecting and focusing the generated mechanical wave toward a lesion to be treated within a blood vessel of the body, according to one embodiment. 1 is a block diagram showing a system including a concentrator; FIG. FIG. 2 schematically illustrates a wave concentrator provided with a recessed outer surface, according to one embodiment. FIG. 3 is a cross-sectional view of a wave concentrator provided with internal reflective surfaces, according to one embodiment. A mechanical wave source for externally generating a mechanical wave and a wave refracting device for refracting the generated mechanical wave toward a lesion to be treated within a blood vessel of the body, according to one embodiment. 1 is a block diagram showing a system including FIG. 2 is a flowchart illustrating a method for treating lesions present within blood vessels of the body, according to one embodiment.

DETAILED DESCRIPTION In addition, like features are identified by like reference numerals throughout the accompanying drawings.

FIG. 1 shows one embodiment of a system 10 for delivering mechanical or shock waves to treat lesions 12 present in blood vessels 14, such as arteries. System 10 includes a mechanical or shock wave source 16 and a minimally invasive wave direction device 18 .

A wave generator 16 is positioned external to the patient's body and adapted to generate mechanical waves. The generated mechanical waves propagate through the patient's body to the wave directing device 18 . Wave directing device 18 is adapted to be inserted into blood vessel 14 and positioned adjacent lesion 12 to be treated. Wave directing device 18 is further adapted to redirect mechanical waves received from wave generator 16 toward lesion 12 . The redirected mechanical wave then propagates through the medium surrounding the wave directing device 18 toward the lesion 12 . The mechanical wave may propagate further into the lesion 12 and cause fissures within the lesion 12 or may ablate the lesion 12, ultimately cutting or shattering the lesion 12 into small pieces. or reduce its stiffness.

In one embodiment, the wave generator 16 is adapted to generate high amplitude, short duration pulses that propagate through the patient's body to the wave directing device 18 . Wave generator 16 may include at least one broadband source and/or at least one narrowband source. A narrowband or broadband source may be an electromechanical transducer. Wave generator 16 may include a spatial concentrator that focuses the output of at least one source toward wave direction device 18 .

It should be understood that wave director 18 is shaped and sized to be inserted into vessel 14 and to travel within and along vessel 14 to lesion 12 . Wave directing device 18 may be further adapted to be oriented according to a desired orientation. For example, wave directing device 18 may be adapted to be rotated. It should also be understood that any suitable device or apparatus and any suitable method for moving the wave directing device 18 within the blood vessel 14 may be used.

In one embodiment, system 10 includes a flexible rod or tube, such as a flexible rod or tube, adapted to engage wave directing device 18 and urge wave directing device 18 to a position within blood vessel 14 adjacent lesion 12 . Further includes an elongated member. In one embodiment, the wave director 18 may be fixedly attached to the elongated member, such as at the distal end of the elongated member. In another embodiment, the wave director 18 may be removably securable to the elongated member, such as at the distal end of the elongated member. When the wave director 18 is inserted into a body vessel, the proximal portion of the elongated member remains outside the body and is manipulated to direct the wave director according to the desired position and orientation relative to the lesion 12 to be treated. It should be understood that 18 may be positioned and oriented.

For example, wave director 18 may be affixable to the distal end of a catheter or balloon. After the wave-directing device is secured to a catheter or balloon, it is introduced into the blood vessel 14 and the catheter or balloon is pushed into the blood vessel 14 to position the wave-directing device 18 adjacent the lesion 12 . In one embodiment, the catheter or balloon may also be rotated to properly orient the wave directing device 18 relative to the lesion 12 .

In another embodiment, wave director 18 may be integral with a flexible rod or tube such as a catheter or balloon. In this case, wave directing device 18 may correspond to a portion of a flexible rod or tube adapted to redirect incident mechanical waves.

In one embodiment, the system 10 includes a position for tracking the position of the wave-directing device 18 within the vessel 14 to properly position and/or orient the wave-directing device 18 relative to the lesion 12 to be treated. Further includes tracking device 20 . For example, position tracking device 20 may be an imaging device for visualizing wave-directing device 18 while wave- directing device 18 is inserted into the patient's body. For example, the imaging device may be an X-ray imaging device. In this case, the wave directing device may be provided with X-ray opaque markers so that they are visible on the X-ray image. The imaging device may also be an ultrasound imaging device, in which case the markers are highly reflective of ultrasound energy. For example, the position tracker may utilize waves reflected back to the position tracker from the wave direction device 18, such as in pulse-echo mode. In this case, the position tracking device 20 includes a mechanical wave detector for detecting mechanical waves reflected by the wave directing device 18, the position and/or orientation of the wave directing device 18 being determined by mechanical wave detection. according to the signal detected by the detector, for example according to the amplitude, phase and/or delay of the waves detected by the mechanical wave detector.

In one embodiment, wave director 18 is adapted to reflect or deflect incident mechanical waves. In this case, the wave directing device 18 may be constructed or coated with a material adapted to reflect mechanical waves. Such reflective materials should have an acoustic impedance greater than the acoustic impedance of the surroundings. A suitable reflective material can be any solid such as a polymer or metal or composite material, since the surroundings include tissue and body fluids that have acoustic impedances approaching that of water. Wave director 18 is then adapted to receive the mechanical wave incident on wave director 18 according to an angle of incidence and to reflect the incident mechanical wave according to an angle of reflection that may be dependent on the angle of incidence. In one embodiment, the wave directing device is a specular reflector such that the angle of reflection of the mechanical wave is equal to the angle of incidence of the mechanical wave. In this case, changing the angle of incidence can change the angle of reflection. In one embodiment, wave directing device 18 is further adapted to focus or converge incident mechanical waves toward a focal point. In this case, the wave directing device 18 may be an acoustic mirror.

In another embodiment, wave director 18 is adapted by a suitable combination of materials and geometry to refract mechanical waves incident on wave director 18 toward a focal point. In this case, the wave directing device 18 may be an acoustic lens.

FIG. 2 illustrates one embodiment of a system 50 for delivering mechanical or shock waves to treat lesions 12 existing within blood vessels 14 . System 50 includes a mechanical wave source or mechanical pulse source 16 and a wave concentrator 52 . Wave source 16 is positioned external to the patient's body and emits mechanical waves or pulses toward wave concentrator 52 . For example, wave concentrator 52 may be constructed of a material adapted to reflect mechanical waves. In another example, the outer or inner surface of wave concentrator 52 may be coated with a material adapted to reflect mechanical waves.

The mechanical waves generated by the wave generator 16 reach a wave concentrator 52 adapted to reflect the incident waves according to the direction of reflection and to further focus or converge the reflected mechanical waves. By properly positioning the wave concentrator 52 with respect to the lesion 12 and properly positioning the wave source 16 with respect to the wave concentrator 52, a focus can be positioned on the lesion 12 to be treated. In one embodiment, the orientation of the wave concentrator 52 is also adjusted to position the focus on the lesion 12 to be treated.

In one embodiment, at least a portion of the outer or inner surface of wave concentrator 52 has a contour adapted to concentrate or focus incident mechanical waves. For example, at least a portion of the outer or inner surface of wave concentrator 52 may have a concave, hemispherical, or parabolic shape. In this case, the mechanical wave is propagated towards the concave, hemispherical or parabolic portion of the wave concentrator 52, which directs the mechanical wave incident on this portion. Concentrate the reflected mechanical waves to a focal point while reflecting.

In one embodiment, at least one characteristic of wave concentrator 52 is adjusted to reflect the direction of reflection of the reflected mechanical wave, the location of the focal point at which the mechanical wave converges, and/or the size of the focal point on the lesion, i.e. , may alter the surface area of the lesion upon which the reflected mechanical wave is incident. For example, the orientation and shape of wave concentrator 52 may be varied by adjusting the curvature of wave concentrator 52 .

FIG. 3a shows one embodiment of a wave concentrator 56. FIG. Wave concentrator 56 includes an elongated body 57 extending between proximal end 58 and distal end 60 . Elongated body 57 includes a first marker portion 62 located at proximal end 58, a second marker portion 64 located at distal end 60, and a central reflective portion 66 located between marker portions 62 and 64. including.

First marker portion 62 and second marker portion 64 are constructed or coated with a marker material, such as a radiopaque material. Examples of suitable radiopaque materials may include platinum, gold, tungsten, alloys of platinum, gold and tungsten, and polymers doped with platinum, gold or tungsten. The first marker portion 62 and the second marker portion 64 are then known that the reflective portion of the wave concentrator 56 is located between the first marker portion 62 and the second marker portion 64. , allowing proper positioning of the wave concentrator 56 relative to the lesion 12 .

At least one portion 68 of the outer surface of central portion 66 is constructed or coated with a material adapted to reflect mechanical waves to further focus mechanical waves incident on portion 68. It is provided with a concave shape that allows

In one embodiment, the shape of reflective portion 68 is adjusted to determine the direction of reflection of the reflected mechanical wave, the location of the focal point at which the mechanical wave converges, and/or the focal size of the mechanical wave on lesion 12 . may be changed. For example, the wave concentrator 56 may comprise any inflatable structure provided with a reflective outer surface, such as an inflatable balloon, where the shape of the reflective portion 68 is such that the balloon is inflated within the wave concentrator 56. / may be adjusted by shrinking. For example, the wave concentrator 56 may be a generally cylindrical or spherical balloon whose principal radius of curvature, and thus its focal length, can be varied by varying the inflation pressure of the fluid present within the balloon. In another example, wave concentrator 56 may be a balloon whose shape may be varied by changing the inflation pressure of the fluid present within the balloon. In this case, it should be appreciated that the system further includes a fluid source fluidly connected to the balloon for inflating/deflating the balloon.

FIG. 3a shows wave concentrator 56 acting as an acoustic mirror with portion 68 of the outer surface being reflective, while FIG. Figure 2 shows a cross-sectional view of a wave concentrator 70 adapted to focus waves; As shown in FIG. 3b, the inner surface of the wave concentrator 70 has a curved or circular cross-sectional shape and is reflective so as to reflect and focus incident mechanical waves. acts as an acoustic mirror adapted to

FIG. 4 illustrates one embodiment of a system 80 for delivering mechanical or shock waves to treat lesions 12 existing within blood vessels 14 . System 80 includes mechanical wave source or mechanical pulse source 16 and wave refracting device 82 . Wave source 16 is positioned external to the patient's body and emits mechanical waves or pulses toward wave-refracting device 82 . For example, wave refracting device 82 may be constructed of a material or combination of materials adapted to refract mechanical waves or shock waves. This material may have an acoustic impedance different from that of the surroundings (eg, the acoustic impedance of water) such that the wave refracting device 82 can act as an acoustic lens. Preferably, the acoustic impedance of the wave refracting device should be different, but not far from the acoustic impedance of the surrounding tissue and/or body fluid. Exemplary wave refracting device materials are polymers and fluids with densities different from water.

The mechanical waves generated by wave generator 16 reach wave refracting device 82 . The wave refracting device 82 may act as an acoustic lens, i.e., the wave refracting device 82 refracts the incident wave according to the direction of refraction and further concentrates or converges the refracted mechanical wave to a focal point. be adapted. The geometry and materials of wave refracting device 82 are selected such that wave refracting device 82 acts as an acoustic lens. By properly positioning and orienting the wave refracting device 82 relative to the lesion 12 and properly positioning and orienting the wave source 16 relative to the wave refracting device 82, a focus can be positioned on the lesion 12 to be treated.

In one embodiment, at least one property of the wave refracting device 82 is adjusted such that the refracted direction of the refracted mechanical wave, the location of the focal point where the mechanical wave converges, and/or the size of the focal point on the lesion, i.e. , may alter the surface area of the lesion upon which the refracted mechanical wave is incident. Examples of properties of the wave-refracting device 82 that can be adjusted include the shape, thickness and/or curvature of the wave-refracting device 82, and the properties within the wave-refracting device 82, such as fluids or liquids that can be contained within the wave-refracting device 82. Materials included.

In one embodiment, the outer surface of the stent may act as a refractive device (ie, lens) that focuses the energy onto the treatment target, which may be internal or external to the stent.

In one embodiment, the wave directing device includes a balloon or catheter adapted to reflect, refract, and/or focus mechanical wave features as described above. In one embodiment, the balloon is filled with a fluid that favors wave reflection, refraction, and/or concentration of mechanical waves. The fluid may be any suitable fluid, such as a liquid having an acoustic impedance different from that of surrounding tissue and/or bodily fluids, for example a fluid or liquid having an acoustic impedance different from that of water. . For example, the fluid may be a liquid with a different density than water. Inflating and/or deflating the balloon changes the shape of the balloon, thereby changing the mechanical wave reflection, refraction, and/or concentration of the device. In one embodiment, the balloon may act as an acoustic mirror or lens, and changing the shape of the balloon can change the location and size of the focal region at the focal point.

In one embodiment, the wave directing device includes at least two balloons adapted to reflect, refract and/or concentrate mechanical wave features as described above. In one embodiment, each of the balloons is filled with a fluid that favors wave reflection, refraction, and/or concentration of mechanical waves. Inflating and/or deflating the balloon changes the shape of the balloon, thereby changing the mechanical wave reflection, refraction, and/or concentration of the device. The fluids within the balloon may be similar or different to provide desired wave reflection, refraction, and/or concentration properties.

In one embodiment, the wave directing device may be serrated for part of its profile, for example to create an acoustic Fresnel lens.

In one embodiment, the geometry of the wave directing device can be adjusted in situ to change its reflective, refractive, and/or focusing properties.

In one embodiment, the wave-directing device provides a refractive index along its length and circumference such that different treatments can be applied simultaneously to a single or multiple lesions using mechanical waves generated by a single source. It includes a combination of equipment parts and concentrator parts.

In one embodiment, the wave directing device includes a mechanical resonant structure that can be used to store at least a portion of the mechanical energy generated by an external mechanical wave source. As is known in the art, a mechanical resonant structure may be a mechanical resonator that includes both inertial devices (mass) and compliant devices (springs), or a combination of a plurality of these elements. The resonant frequency or frequencies of the resonator are tuned to the resonant frequencies of the waves such that the mechanical wave interaction of the waves with the resonator causes the resonator to operate. This action stores kinetic and spring energy, which can later be used for other purposes. In practice, therefore, the resonator can be a spring and mass or a combination of many springs and masses. The stored mechanical energy can be used to treat surrounding tissue through direct mechanical action, such as vibration or impact, or indirect mechanical action, such as drug release. In the case of drug release, this can be combined with simultaneous external mechanical energy exposure to facilitate drug uptake by the treatment target tissue.

In one embodiment, the minimally invasive wave-directing device is a single piece for delivering fluids, e.g., drugs, vaccines or other therapeutic substances, to a therapeutic target or for cooling/heating a therapeutic target. Further included is a fluid delivery system comprising a fluid delivery tube as described above. Liquid delivery can occur before, concurrently with, or after external mechanical energy exposure. For drug delivery, this can be combined with simultaneous external mechanical energy exposure to enhance drug uptake by the treated lesion.

In one embodiment, the minimally invasive wave direction device is coated with a drug, vaccine or other therapeutic substance. A drug, vaccine or other therapeutic substance can diffuse into a lesion when the minimally invasive wave-directing device is brought into contact with the lesion to be treated. Subsequent mechanical energy exposure may further enhance drug uptake by the treated lesion. In another embodiment, these drugs, vaccines or other therapeutic substances may be released by the action of mechanical energy exposure, which may further facilitate drug uptake by the treated lesion.

In one embodiment, the minimally invasive wave-directed device comprises a capsule containing a drug, vaccine, or other therapeutic substance. Mechanical energy exposure can release capsules of these drugs, vaccines or other therapeutic substances into the lesion to be treated in contact with the minimally invasive wave direction device. For example, a drug may be encapsulated in a capsule secured to a minimally invasive wave direction device, the capsule being rupturable under the influence of a mechanical wave to release the drug. Subsequent mechanical energy exposure may further enhance drug uptake by the treated lesion.

In one embodiment, the wave-directing device further includes one or more suction tubes, for example, for suctioning debris generated by the procedure.

In one embodiment, the wave generators may be focused, e.g., by utilizing an appropriately shaped profile, or by utilizing a large number of individual wave generators in a phased array. Alternatively, an additional focussing step may be added between vessel 14 and mechanical wave source 16 . For example, an acoustic lens may be used to focus the wave generator.

In one embodiment, the wave generator may generate mechanical waves of various types, some of which may be more suitable for treating lesions, some of which may be used by the position tracking device. may be more suitable for locating wave direction devices in pulse-echo mode in conjunction with .

In one embodiment, the wave direction device further comprises an optical coherence tomography (OCT) or intravascular ultrasound (IVUS) imaging device.

In one embodiment, the wave-directing device includes at its distal end a medicament (or similar) capsule that can be triggered (released) from the proximal end by a mechanism extending along the length of the wave-directing device. .

In one embodiment, the wave direction device includes piezoelectric elements that generate electricity when exposed to mechanical energy generated by an external source.

In one embodiment, the wave-directing device includes one or more frangible elements that are breakable when exposed to mechanical energy generated by an external source.

In one embodiment, the outer surface of the wave director includes features such as roughness and/or porosity that promote localized cavitation when exposed to mechanical energy generated by an external source.

In one embodiment, the external mechanical wave source is in acoustic coupling contact with the patient's skin to maximize energy transfer.

In one embodiment, the external mechanical wave sources are circumferentially arranged around the axis. For example, an external mechanical wave source can wrap completely or partially around a leg, arm, head or torso.

In one embodiment, the external mechanical wave source, coupled or uncoupled to the wave concentrator, is not adapted to focus sufficient mechanical energy to obtain sufficient energy to directly treat the lesion. In this case, the wave concentrators and wave refractors described above can further concentrate the mechanical energy delivered by the mechanical source to achieve the appropriate amount of energy concentration to treat the lesion.

FIG. 5 illustrates one embodiment of a method 100 for treating lesions present within blood vessels of the body.

At step 102, a wave-directing device is inserted into a body vessel and positioned at step 104 adjacent a lesion to be treated. The wave directing device is positioned and oriented according to the desired position and desired orientation relative to the lesion to be treated. The desired position and orientation are selected such that mechanical waves incident on the wave directing device propagate toward the lesion to be treated.

At step 106, a mechanical wave is generated using an external mechanical wave source located outside the body, and the generated mechanical wave is propagated toward a wave directing device.

At step 108, the lesion is treated by redirecting and focusing the mechanical waves incident on the wave directing device to the lesion.

In one embodiment, redirecting the mechanical wave comprises reflecting the mechanical wave. In this case, the wave directing device is adapted to reflect and concentrate mechanical waves received from an external mechanical wave source, as described above. For example, the wave directing device may be an acoustic mirror.

In another embodiment, turning the mechanical wave comprises refracting the mechanical wave. In this case, the wave directing device is adapted to refract and focus mechanical waves received from an external mechanical wave source, as described above. For example, the wave directing device may be an acoustic lens.

In embodiments where the wave directing device is an inflatable balloon, the method 100 further includes inflating or deflating the balloon to obtain the desired shape of the balloon prior to generating the mechanical waves. As mentioned above, the balloon may be adapted to reflect mechanical waves or to refract mechanical waves.

In embodiments in which the wave-directing device is fixed to the elongated member, positioning 104 the wave-directing device includes manipulating the proximal end of the elongated member; and/or rotating.

In one embodiment, the method 100 further includes using the position tracking device to detect at least one of the position and orientation of the wave-directing device once the wave-directing device is inserted into the blood vessel.

In one embodiment, detection of the position and/or orientation of the wave direction device is performed using an X-ray imager or an ultrasound imager.

In another embodiment, the detection of the position and/or orientation of the wave direction device includes detecting mechanical waves reflected by the wave direction device with a mechanical wave detector, Determining the position and/or orientation from the amplitude, phase and/or delay of the mechanical wave.

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

Claims (19)

1. A system for transmitting high amplitude, short duration pulsed mechanical waves to treat lesions present in blood vessels of the body, comprising:
generating a high amplitude, short duration pulsed mechanical wave from outside the body; and directing the high amplitude, short duration pulsed mechanical wave through the body in the direction of the wave. The high amplitude, short duration pulsed mechanical wave configured for propagation to the device has an amplitude between 1 MPa and 1000 MPa and a duration of 1/fc, where fc is between 20 kHz and _{10 MHz} . an external mechanical wave source with a center frequency between
a wave-directing device insertable into the vessel, the wave-directing device positionable and directable within the vessel relative to the external mechanical wave source and to the lesion, wherein the wave-directing device comprises: ,
receiving the high amplitude, short duration pulsed mechanical wave generated by the external mechanical wave source;
Redirecting and focusing the high amplitude, short duration pulsed mechanical wave toward a focal point on the lesion along the target direction , with an amplitude between 1 MPa and 1000 MPa and a duration of 1/fc. A system configured to treat said lesion using said high amplitude, short duration pulsed mechanical wave, wherein fc is time and fc is a center frequency between 20 kHz and 10 MHz. 2. The system of claim 1, wherein the wave directing device is adapted to reflect the high amplitude, short duration pulsed mechanical waves received from the external mechanical wave source onto the lesion. . 3. The system of claim 1, wherein the wave director comprises at least one portion having one of a concave shape, a spherical shape, a hemispherical shape, and a parabolic shape. 3. The system of claim 2, wherein the wave direction device is one of constructed of and coated with a reflective material having an acoustic impedance greater than that of water. 3. The system of claim 2, wherein the wave directing device comprises an acoustic mirror. 2. The system of claim 1, wherein the wave director is adapted to refract the high amplitude, short duration pulsed mechanical waves received from the external mechanical wave source. 7. The system of claim 6, wherein the wave direction device is constructed of a material having an acoustic impedance different from that of water. The wave-directing device is configured to refract the high-amplitude, short-duration pulsed mechanical wave according to a direction of refraction, and to refract the refracted high-amplitude, short-duration pulsed mechanical wave. 7. The system of claim 6, adapted to focus waves to a focal point. 2. The system of claim 1, wherein the wave directing device comprises at least one marker visible on medical images. 10. The system of claim 9, wherein the marker is composed of radiopaque material. The wave-directing device includes an inflatable balloon, and the system includes a fluid source fluidly connected to the inflatable balloon for injecting fluid into the interior of the inflatable balloon to change the shape of the balloon. 2. The system of claim 1, further comprising: 12. The system of Claim 11, wherein the inflatable balloon is adapted to act as one of an acoustic lens and an acoustic mirror. 3. The system of claim 1, further comprising an elongated member, the wave director being removably or integrally secured to the elongated member. 14. The system of Claim 13, wherein the elongate member comprises one of a balloon and a catheter. 2. The system of claim 1, further comprising a position tracking device for tracking at least one of the position and orientation of the wave-directing device once the wave-directing device is inserted into the vessel of the body. 16. The system of claim 15, wherein the position tracking device comprises one of an X-ray imager and an ultrasound imager. The position tracking device comprises a mechanical wave detector for detecting high amplitude, short duration pulsed mechanical waves reflected by the wave directing device, the position of the wave directing device and Said at least one of said orientations is determined according to at least one of amplitude, phase and delay of a high amplitude short duration pulsed mechanical wave detected by said mechanical wave detector. 16. The system of claim 15. 2. The system of claim 1, wherein said wave directing device comprises a mechanical resonant structure for storing or returning mechanical energy. 2. The system of claim 1, wherein the wave directing device is adapted to focus the high amplitude, short duration pulsed mechanical waves received from the external mechanical wave source.

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