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WO2025085813A1 - Lithotripsie extracorporelle - Google Patents

Lithotripsie extracorporelle Download PDF

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Publication number
WO2025085813A1
WO2025085813A1 PCT/US2024/052066 US2024052066W WO2025085813A1 WO 2025085813 A1 WO2025085813 A1 WO 2025085813A1 US 2024052066 W US2024052066 W US 2024052066W WO 2025085813 A1 WO2025085813 A1 WO 2025085813A1
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WO
WIPO (PCT)
Prior art keywords
lithotripsy
target
extracorporeal
emitters
reflectors
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/052066
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English (en)
Inventor
Ami Mehta
Ross Tsukashima
Ronak DHOLAKIA
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Terumo Corp
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Terumo Corp
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Filing date
Publication date
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Publication of WO2025085813A1 publication Critical patent/WO2025085813A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • A61B17/2251—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • A61B17/2255—Means for positioning patient, shock wave apparatus or locating means, e.g. mechanical aspects, patient beds, support arms or aiming means

Definitions

  • an extracorporeal lithotripsy device designed to disrupt calcification or vascular buildup includes of a support structure with a surface facing the target. On this support structure, there are multiple lithotripsy emitters that emit a signal, and adjacent to them, there are multiple lithotripsy reflectors. These emitters and reflectors work together to deliver the signal to a calcified plaque target located at a distance from the device's surface.
  • an extracorporeal lithotripsy device designed for disrupting calcification or other vascular buildup includes a support structure with a surface facing the target. It consists of means for emitting a signal from the surface towards a calcified plaque target and means for reflecting the signal towards the target. These means work together on the support structure to deliver shockwaves to the calcified plaque target.
  • the target in this case, can be a calcified plaque located at a distance from the device's surface.
  • the support structure may be in the form of a belt or brace encircling the calcified plaque target.
  • the means for emitting and reflecting the signal can be designed to provide a tunable peak pressure at the calcified plaque target, exceeding 20 MPa.
  • the means for emitting the signal can be spark-gap, piezoelectric, photoacoustic, or ultrasonic emitters. Multiple means for emitting the signal and reflecting the signal can be present, with each emitter spaced from its corresponding reflector by a degassed fluid.
  • An interface gel can be applied to the targetfacing surface.
  • a method for extracorporeal lithotripsy involves generating an image of a region that contains a vascular structure. From this image, a target corresponding to calcification or other vascular buildup in the structure is identified. Subsequently, a shockwave treatment is applied to the target using an extracorporeal device.
  • the extracorporeal device used in the method can include a support structure with a target-facing surface, multiple lithotripsy emitters arranged on the support structure to emit a signal from the surface, and multiple lithotripsy reflectors arranged adjacent to the emitters on the support structure. These emitters and reflectors work together to deliver the signal to the target.
  • the method may also involve performing a balloon angioplasty, using a drug-coated balloon if needed.
  • Generating the image can be done through ultrasound or fluoroscopic imaging. Both imaging techniques can be employed together.
  • the lithotripsy reflectors can be mounted in the support structure, which can be in the form of a belt or brace encircling the target.
  • the emitters and reflectors are configured to provide a tunable peak pressure at the target, exceeding 20 MPa.
  • the emitters can be spark-gap, piezoelectric, or ultrasonic emitters, and each emitter can be separated from its corresponding reflector by a degassed fluid.
  • An interface gel can be applied to the target-facing surface.
  • the reflectors can be formed by a single reflector along the surface.
  • the target can be imaged during the shockwave treatment using X-ray or ultrasound imaging.
  • the reflectors can be arranged so that the focal point of each reflector aligns with the target, based on the generated image of
  • FIG. l is a simplified cross-sectional view of an extracorporeal lithotripsy device.
  • FIG. 2 is a detailed schematic view of a single extracorporeal lithotripsy emitter and corresponding extracorporeal lithotripsy reflector.
  • FIG. 3 shows a simplified cross-sectional view of an extracorporeal lithotripsy system including imaging.
  • FIG. 4 is a simplified side view of a horizontal extracorporeal lithotripsy device.
  • FIG. 5 is a flowchart of a method for performing extracorporeal lithotripsy.
  • vascular calcification is a pathologic response to toxic stimuli involving metabolic substances and or inflammatory cells.
  • vascular calcification is a pathologic response to toxic stimuli involving metabolic substances and or inflammatory cells.
  • Intimal calcification is associated with atherosclerotic plaque.
  • Intimal calcium causes stenotic lesions and causes obstructed blood flow. Obstructed blood flow may lead to decreased organ perfusion and ischemia.
  • Medial calcification results from osteogenic differentiation of vascular smooth muscle cells within medial layer of the vessel wall. Medial calcification is not associated with luminal obstruction.
  • Other systems include a generator, cable, and a single-use catheter with a balloon containing lithotripsy emitters.
  • the emitters send sonic pressure waves to fracture calcium, which allows the artery to be dilated with low balloon pressure.
  • This may be a standalone therapy or may be used as a first step to treat more calcified plaque, where a balloon or stent is later introduced to provide continued treatment of the target site. While this approach offers some promise, it is an interventional procedure which carries its own set of risks.
  • the device outlined below and shown in the attached figures utilizes an electromechanical or electrohydraulic device which sits externally around the target region and delivers pulsatile forces to the vessels within the body underneath the electromechanical device.
  • the device can be considered a belt which sits horizontally or vertically around the target region.
  • the device has particular utility for treatment of calcification in the SFA and popliteal arteries, and particular at the below-the-knee region which current technologies have difficulty to treat, the device can be used in a variety of locations where there is calcification in the vasculature.
  • Lithotripsy utilizes a signature waveform (an acoustic shockwave), and the produced pressure pulse is responsible for breaking calcifications.
  • a typical shock wave begins with a near instantaneous jump to a peak positive pressure of 30 to 110 MPa. This fast transition in the waveform is referred to as a shock. The transition is faster than can be measured and is less than 5 ns in duration. The pressure then falls to zero followed by a negative pressure trough (tensile wave). The intense compressive wave induces mechanical forces inside the stone that may lead to fracturing.
  • Current generation shockwave lithotripsy systems are equipped with integrated adjustable isocentric Fluoroscopic C-arm (x-ray) and lateral ultrasound (optional available in dual localization systems) for stone localization.
  • peak pressure about 3-5 MPa, 0.1-0.3 mj/mm2 is preferred to induce angiogenesis and reduce calcification.
  • Multiple sessions in this range involving 200 shots/spot at about 3 times a week for three weeks has been observed to treat the target disease state without injuring soft tissue.
  • a peak pressure of about 5 MPa introduced through the pulsatile balloon has been observed to crack the calcification.
  • a single session of at least 30 pulses of about 1 microsecond at about 1 HZ for between about 30 to about 180 pulses has been observed to treat calcification in the SFA without injuring soft tissue.
  • the lithotripsy embodiments discussed herein utilize an extracorporeal lithotripsy device in the form of a vertical or a horizontal belt that sits around the target region.
  • the lithotripsy device is used to treat calcifications in the knee or leg region and takes the form of a knee brace or belt that delivers focused pulsatile energy to calcified plaque.
  • shockwave pulses are used to deliver this energy.
  • the goal of the device is to weaken or crack calcium deposits in the peripheral artery, either as a standalone treatment, or to improve the efficacy of a follow-up treatment such as balloon angioplasty, drug coated angioplasty, and/or intravascular stenting.
  • the device incorporates lithotripsy emitters and reflectors capable of imparting the pulsatile energy externally and reaching the target vessel region.
  • water media entraps the emitters for efficient transfer of shockwave to the body.
  • a variety of methods include spark-gap, piezoelectric transmitters, ultrasonic systems can be used to impart the pulsatile force.
  • Extracorporeal lithotripsy device 100 can extend around the calcified plaque target 104, such as in the form of a loop around the bone 106, muscle 108, and vasculature 110 as shown in FIG. 1.
  • support structure 102 can be a belt or brace, in some embodiments, that fits around a patient at a calcified plaque target 104.
  • Target-facing surface 112 is an interface between the extracorporeal lithotripsy device 100 and the patient.
  • Target-facing surface 112 may be, for example, the radially inner surface of a belt that is fastened snugly to the patient, such that the extracorporeal lithotripsy device 100 is in good acoustical shockwave coupling with the patient.
  • extracorporeal lithotripsy device 100 includes a plurality of lithotripsy emitters 114.
  • Each of the plurality of lithotripsy emitters 114 shown in FIG. 1 is paired with a corresponding one of a plurality of lithotripsy reflectors 116 that is arranged adjacent that one of the plurality of lithotripsy emitters 114.
  • each of the plurality of lithotripsy emitters 114 is separate and distinct from the others, and each of the plurality of lithotripsy reflectors 116 is separate and distinct from one another.
  • this may not always be the case.
  • a single reflective parabolic trough could function as a lithotripsy reflector for multiple ones of the plurality of lithotripsy emitters 114, or indeed for all of them.
  • a corrugated pattern could be used to use a unitary component or piece of reflective material to function as a lithotripsy reflector for multiple ones of the plurality of lithotripsy emitters 114.
  • Each of the plurality of lithotripsy emitters 114 is capable of producing a shockwave pulse.
  • the shockwave having a pressure sufficient to travel through the patient towards the target and, at the target, remain sufficiently strong to cause calcium cracking.
  • shockwave pulse As described above, it has been found that about 5MPa of intravenous pressure in a shockwave pulse is sufficient when it arrives at a calcified plaque target 104 to cause cracking thereof. Conversely, sufficiently high shockwave pulses can cause discomfort or injury to the patient. However, it has been found that there is a window of pulse strengths that will create a sufficiently high pressure pulse at the calcified plaque target 104 without causing discomfort or injury. It is therefore often the case that the plurality of lithotripsy emitters 114 will create a shockwave pulse of about lOOMPa.
  • the extracorporeal lithotripsy shockwave formed by the plurality of lithotripsy emitters 114 can be between about 20-300 MPa, or more preferably between about 20MPa and 100 MPa for low-pressure applications or between about 100 MPa and about 300 MPa for high range applications.
  • the plurality of lithotripsy emitters 114 can each be a spark-gap emitter, a piezoelectric emitter, or an ultrasound emitter.
  • a 30kV spark gap emitter can be used to produce an appropriate pressure pulse of at least 100 MPa.
  • the plurality of lithotripsy reflectors 116 facilitate providing sufficient pressure to the calcified plaque target 104.
  • the amount of energy that must be expended at the plurality of lithotripsy emitters 114 to provide sufficient pressure in the shockwave at the calcified plaque target 104 can depend in part upon the expected attenuation of the signal en route to the calcified plaque target 104. This efficiency is at least partially based upon the efficiency with which the initial shockwave is focused.
  • the plurality of lithotripsy reflectors 116 can be reflective to shockwaves.
  • the plurality of lithotripsy reflectors 116 may be semi-circular, parabolic, or otherwise shaped to focus a signal produced by the plurality of lithotripsy emitters 114 towards the calcified plaque target 104.
  • the plurality of lithotripsy emitters 114 and their corresponding plurality of lithotripsy reflectors 116 need not along the entire loop formed by the support structure 102.
  • the plurality of lithotripsy emitters 114 and their corresponding plurality of lithotripsy reflectors 116 do not extend around the portion of the support structure in which the signal produced therefrom would travel through bone 106.
  • Material differences e.g., changing from bone to muscle, or muscle to fat, or through blood
  • signal that passes through material discontinuities may arrive at the calcified plaque target 104 either strongly attenuated, or to the wrong position, or worse yet out-of-phase with signal from other ones of the plurality of lithotripsy emitters 114 to cause destructive interference. Accordingly, it may be preferable in embodiments to position the plurality of lithotripsy emitters 114 and the plurality of lithotripsy reflectors 116 in locations where the strength, direction, and timing of the signal produced therefrom is more predictable.
  • the plurality of lithotripsy emitters 114 are arranged with their counterpart plurality of lithotripsy reflectors 116 focused at the calcified plaque target 104.
  • the support structure 102 holds the plurality of lithotripsy emitters 114 and the plurality of lithotripsy reflectors 116 in position to provide the signal therefrom to the calcified plaque target 104.
  • the support structure 102 may be customized to receive the plurality of lithotripsy emitters 114 and the plurality of lithotripsy reflectors 116 in a desired position and orientation based upon a known position of the calcified plaque target 104 that has been acquired in an imaging scan, such as a diagnostic ultrasound or a fluoroscopic image.
  • the support structure 102, the plurality of lithotripsy emitters 114, and/or the plurality of lithotripsy reflectors 116 may be customized, such as by 3D printing or manually arrangement by a technician, for customized therapeutic treatments.
  • some components of the extracorporeal lithotripsy device 100 may be replaceable or repairable.
  • the plurality of lithotripsy emitters 114 may be replaced after a certain amount of usage, for example in the case of spark gap emitters that have a maximum usable lifespan.
  • the extracorporeal lithotripsy device 100 of FIG. 1 can be operated by powering the plurality of lithotripsy emitters 114 to create acoustic signal (e.g., acoustic shockwaves).
  • the plurality of lithotripsy emitters 114 can be powered in concert with one another, such as simultaneously or at defined delays relative to one another, to cause sufficient pressure at the calcified plaque target 104 for cracking.
  • FIG. 2 is a detailed schematic view of a single lithotripsy emitter 114 with its corresponding lithotripsy reflector 116. Similar components are shown in FIG. 2 to those that were previously described in FIG. 1. Throughout this application, where like parts are shown in multiple figures, they will share a reference number, or will have a reference number that is iterated by a factor of one hundred. Description of components that have previously been described will not be repeated in subsequent figures, and it should be understood that the descriptions from earlier figures applies in the later ones as well unless otherwise specified.
  • the single lithotripsy emitter is arranged in the support structure 102, which has a target-facing surface 112.
  • the calcified plaque target 104 is remote from the target-facing surface 112.
  • a The lithotripsy emitter 114 creates a shockwave that is focused by the lithotripsy reflector 116 to become signal 218.
  • Signal 218 travels along the distance 220 between the target-facing surface 112 and the calcified plaque target 104.
  • the focal point 222 of the signal 218 is substantially at the calcified plaque target 104.
  • “Substantially,” in the context of this disclosure, refers to being at or within the calcified plaque target 104, such that the peak pressure for calcium cracking is applied to the calcified plaque target 104.
  • the focal point 222 may also be referred to as a focal region, as acoustic shockwave signal will not focus to a precise point, therefore focal point 222 may refer to a region that substantially overlaps the calcified plaque target 104. In other words, when the region in which the focused acoustic pressure shockwave is strong enough to crack calcium will at least partially include some of the calcified plaque target 104, this is substantial overlap.
  • the space between lithotripsy emitter 114 and lithotripsy reflector 116 is filled with a material that has appropriate acoustic transmission properties to provide a well-focused shockwave signal with low energy loss.
  • the space between lithotripsy emitter 114 and lithotripsy reflector 116 can be filled with degassed fluid 224.
  • the lithotripsy emitter 114 and lithotripsy reflector 116 can be housed in a module that is filled with the degassed fluid 224, and the module can be inserted into the support structure 102, either permanently or replaceably.
  • Some of the arrows on FIG. 2 indicate adjustments that can be made in certain embodiments.
  • the crossed arrows indicate movability of the lithotripsy emitter 114 and lithotripsy reflector 116, either side to side or left and right with respect to the page. Positioning the lithotripsy emitter 114 and lithotripsy reflector 116 in the support structure 102 can affect where the focal point 222 is positioned.
  • focal point 222 set to overlap with the calcified plaque target 104, but in embodiments the focal point 222 of each of the plurality of lithotripsy emitters 114 and their corresponding plurality of lithotripsy reflectors 116 can be coordinated to be targeted at the same or substantially the same focal point 222 to increase the cracking pressure.
  • the double-headed arrows in FIG. 2 depict modifications that can be made to the one of the plurality of lithotripsy reflectors 116 that is depicted therein.
  • the focal point 222 will change.
  • the plurality of lithotripsy emitters 114 and the plurality of lithotripsy reflectors 116 can be modified in several ways for different uses.
  • a very deep calcified plaque target 104 may be in a thigh, in which case the focal point 222 can be set at a large distance 220 by modifying the curvature of the plurality of lithotripsy reflectors 116 to be relatively shallower.
  • the plurality of lithotripsy emitters 114 may be configured for creation of high power output, to account for the expected signal dissipation across the larger distance 220.
  • the focal point 222 can be set at a small distance 220 by modifying the curvature of the plurality of lithotripsy reflectors 116 to be relatively high.
  • the plurality of lithotripsy emitters 114 may be configured for creation of low power output, because not as much power is needed to create sufficient pressure for calcium cracking at the calcified plaque target 104.
  • FIG. 3 shows an extracorporeal lithotripsy system 300, which includes an extracorporeal lithotripsy device (such as the extracorporeal lithotripsy system 100 of FIG. 1) as well as an interface gel 326 and an imaging system 328.
  • an extracorporeal lithotripsy device such as the extracorporeal lithotripsy system 100 of FIG. 1
  • an interface gel 326 such as the extracorporeal lithotripsy system 100 of FIG.
  • Interface gel 326 is positioned between the support structure 302 and the body, along the target-facing surface 312. Interface gel 326 can form a better shockwave transfer between the extracorporeal lithotripsy system 300 and the body. Providing interface gel 326 in this region promotes the pressure wave generated by the plurality of lithotripsy emitters 314 that is focused by the plurality of lithotripsy reflectors 316 being transferred towards the calcified plaque target 304 rather than lost. It should be understood that while interface gel 326 is commonly used for imaging and other acoustic shockwave coupling purposes, any interface material may be used, such as a non-gel fluid, in alternative embodiments.
  • Imaging system 328 is provided around the rest of the extracorporeal lithotripsy system 300 and can be used to determine the position, size, or status of the calcified plaque target 304 as well as the other anatomical features such as bone 306 and muscle 308. Imaging system 328 can therefore be used to provide information that affects the positioning, targeting, and power level used by the plurality of lithotripsy emitters 314 and their corresponding plurality of lithotripsy reflectors 316. In some embodiments, imaging system 328 can be arranged specifically to image the calcified plaque target 304. Imaging system may be an X-ray imaging system.
  • FIG. 4 shows a horizontal array extracorporeal lithotripsy device 400.
  • the lithotripsy emitters were arranged along at least a part of a loop around a target.
  • a calcified plaque target 404 may extend along the body, such as through an artery that travels along the length of a leg.
  • a horizontal array extracorporeal lithotripsy device 400 may provide treatment to more of the calcified plaque target 404 than could be accomplished by a loop- or belt-style device.
  • Horizontal array extracorporeal lithotripsy device 400 includes a support structure 402, which extends along the body linearly. Horizontal array extracorporeal lithotripsy device 400 also includes straps 403, which are attached to support structure 402 and to the patient to maintain the support structure 402 in a fixed position relative to the calcified plaque target 404. As such, the plurality of lithotripsy emitters 414 and their corresponding plurality of lithotripsy reflectors 416 are arranged to provide acoustic pulses or shockwaves along the length of calcified plaque target 404.
  • FIG. 4 also depicts voltage supply 430.
  • Voltage supply 430 provides power to the plurality of lithotripsy emitters 414. Similar voltage supplies can be used in the embodiments described with respect to FIGS. 1-3.
  • Voltage supply 430 may include control circuits, power supply, capacitor banks, and trigger signal generators to provide burst of power to the plurality of lithotripsy emitters 414.
  • voltage supply 430 may include circuitry that coordinates the actuation of the plurality of lithotripsy emitters 414, either such that they fire simultaneously, or so that they fire at desired delays relative to one another to constructively interfere their pressure waves at the calcified plaque target 404.
  • Voltage supply 430 may be a high voltage power supply of approximately 30,000 volts. DC power may be connected to the electrodes and controlled by a triggered spark gap. An array of high voltage capacitors are mounted across the DC power supply output lines and provide the large current needed to vaporize water across the electrodes in the reflector.
  • a 24Vdc power supply may be connected to the primary side of an automotive spark plug coil that serves as a lithotripsy emitter.
  • a switch may be pressed causing the primary field to collapse, inducing a high voltage pulse on the secondary side of the coil.
  • This pulse is connected to the triggered spark gap which creates an ionization field that allows the triggered spark gap to discharge the stored 30,000Vdc for shockwave generation.
  • Using this technique over 10,000 amps can be released across submerged electrodes within 1 millisecond.
  • a spark-gap system where a plurality of emitters and reflectors are spaced with degassed fluid acting as a conductive fluid between the various emitters and reflectors. A current is produced between the electrodes which creates a pulsatile spark. Water fills the vacant space in the device to provide another conductive fluid media. An interface gel can further be used to minimize the air gap between the skin and the device.
  • the device, systems, and methods are illustrative shown in the attached figures, as well as various components. Power used to create the plasma field have been measured at 30,000 v/10,000amps for resulting in shockwave pulses of up to 300MPa. measured using fiber optic hydrophones.
  • FIG. 5 shows a method 500 for extracorporeal lithotripsy.
  • a patient is optionally scheduled for a peripheral artery intervention at 502.
  • a diagnostic ultrasound or a CT scan may be performed at 504 in preparation for the peripheral artery intervention.
  • a diagnosis of the peripheral arteries can be formed.
  • the peripheral arteries can be fluoroscopically imaged, such as with lateral projection, at 506.
  • shockwave treatment is performed.
  • the method may further include creating or modifying an extracorporeal lithotripsy device like the ones described with respect to FIGS. 1-4 that is appropriate for the shockwave treatment at 508.
  • Forming or modifying the device may include, for example, adjusting the focus depth, power output, or position of the lithotripsy emitters in a support structure.
  • Shockwave treatment 508 can be carried out for an appropriate number of pulses to crack the calcium at the target.
  • the patient may undergo angioplasty, such as drug-coated balloon angioplasty.
  • angioplasty at 510 may occur while the shockwave treatment at 508 is still being performed.
  • shockwave treatment 508 and/or angioplasty 510 Upon completion of shockwave treatment 508 and/or angioplasty 510, the patient is discharged at 512. Throughout any or all of the elements of method 500, imaging can be performed, such as with an X-ray imaging system as depicted in FIG. 3.
  • the disclosure above sets forth several extracorporeal lithotripsy devices that can be used to treat calcified plaque buildup in blood vessels.
  • These devices can include a support structure, lithotripsy emitters, and lithotripsy reflectors.
  • the devices can be worn as a belt or brace around the target region, such as the leg or knee, where calcified plaque has narrowed the blood vessels and reduced blood flow.
  • Advantages of these devices are that they offer non-invasive treatment option for calcified plaque, which is typically difficult to treat with traditional methods like balloons and stents.
  • the devices deliver focused pulsatile energy to the calcified plaque externally, without the need for invasive procedures. They use shockwave pulses created by lithotripsy emitters to weaken or crack the calcium deposits in the blood vessels.
  • a device as described herein may improve blood flow, prevent further complications, and reduce the need for amputation in severe cases. It can be used as a standalone treatment or in combination with other interventions like balloon angioplasty or stenting.
  • the device can be customized and adjusted based on the location and characteristics of the calcified plaque.
  • the position, orientation, and power level of the lithotripsy emitters and reflectors can be modified to focus the acoustic shockwave pulses accurately on the target region.
  • the device includes an interface gel that enhances the transfer of acoustic shockwaves between the device and the body, as well as an imaging system to guide the treatment and assess the effectiveness of the procedure.
  • This extracorporeal lithotripsy device provides unique advantages due to its non-invasiveness, effectiveness against calcified plaque, customization for different target regions, and the potential to improve blood flow and prevent further complications associated with reduced blood passage and compliance of the arteries.

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Abstract

Un dispositif de lithotripsie extracorporelle est conçu pour perturber la calcification ou une autre accumulation vasculaire dans le corps. Le dispositif est constitué d'une structure de support ayant une surface tournée vers la cible, d'une pluralité d'émetteurs de lithotripsie, et d'une pluralité de réflecteurs de lithotripsie. Les émetteurs de lithotripsie émettent un signal à partir de la surface faisant face à la cible, qui est réfléchi par les réflecteurs de lithotripsie vers une cible de plaque calcifiée située à une certaine distance du dispositif. La structure de support peut se présenter sous la forme d'une ceinture ou d'une attelle qui encercle la région cible. Le dispositif permet une distribution de pression de pic accordable au niveau de la cible, avec l'option d'utiliser des émetteurs à éclateur, des émetteurs piézoélectriques ou des émetteurs ultrasonores. La pluralité de réflecteurs de lithotripsie peut être ajustée dans de multiples directions pour obtenir une focalisation précise des ondes de choc sur la cible. Le dispositif peut être utilisé conjointement avec des systèmes d'imagerie, tels qu'une imagerie par rayons X, pour guider le processus de traitement.
PCT/US2024/052066 2023-10-19 2024-10-18 Lithotripsie extracorporelle Pending WO2025085813A1 (fr)

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US20100137754A1 (en) * 2007-01-10 2010-06-03 Yufeng Zhou Shock wave lithotripter system and a method of performing shock wave calculus fragmentation using the same
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