Extracorporeal lithotomy

Abstract

An extracorporeal lithotripsy device is designed to disrupt calcification or other vascular accumulations in the body. The device consists of a target-facing surface, a support structure with multiple lithotripsy emitters, and multiple lithotripsy reflectors. The lithotripsy emitters emit signals from the target-facing surface, which are reflected by the lithotripsy reflectors toward a calcified plaque target located at a certain distance from the device. The support structure may take the form of a belt or brace surrounding the target area. The device allows for adjustable peak pressure delivery to the target, with the option of using spark gap emitters, piezoelectric emitters, or ultrasonic emitters. The multiple lithotripsy reflectors can be adjusted in multiple directions to achieve precise focusing of shock waves on the target. The device can be used in conjunction with imaging systems, such as X-ray imaging, to guide the treatment process.

Description

TECHNICAL FIELD

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 591,637 filed on October 19, 2023, the disclosure of which is hereby incorporated by reference in its entirety into the present specification. BACKGROUND ART

[0002] The accumulation of plaque and calcification in the vasculature can lead to numerous complications. Calcification can cause hardening of blood vessels, resulting in reduced blood flow, which can impair the function of tissues and organs in the affected areas of the body, and over time, can lead to further complications such as amputation. One area where this accumulation is common is in the peripheral regions of the vasculature, including the legs.

[0003] Many current treatment protocols utilize interventional devices such as balloons and stents, but these devices have their own drawbacks. Conventional balloon angioplasty only addresses soft tissue and is not very effective against hardened calcifications. In addition, restenosis (i.e., the reduction in the diameter of the vascular lumen after angioplasty) is a common problem associated with treatment using such balloons. Drug-coated balloons are also commonly used, but the volume of drug or other substance that can be coated on the balloon is inherently limited. Therefore, the effectiveness of such treatments is reduced for significant hardening, as the calcified layer tends to impede drug distribution. Stenting is not effective when there is significant calcification and restenosis is a common problem.

[0004] Recent technologies leverage the delivery of pulsating pressure or shock waves to the target area where hardening occurs, but this approach utilizes an invasive surgical procedure in which the pulsating device is physically introduced into the vascular treatment site, which itself carries a risk of complications. SUMMARY OF THE INVENTION [Problems that the invention aims to solve]

[0005] There is a need for effective and non-invasive methods to address this problem. [Means for solving the problem]

[0006] Systems and methods for extracorporeal lithotripsy are described herein.

[0007] According to the first example, an extracorporeal lithotripsy device designed to disrupt calcification or vascular accumulation includes a support structure with a target-facing surface. This support structure has multiple lithotripsy emitters that emit signals, and multiple lithotripsy reflectors adjacent to these emitters. These emitters and reflectors work together to deliver signals to a calcified plaque target located at a certain distance from the device surface.

[0008] The extracorporeal lithotripsy device may include a support structure that can take the form of a belt or brace surrounding the calcified plaque target. The emitter and reflector may be designed to allow for adjustable peak pressure at the target, with peak pressures exceeding 100 MPa. The emitter may be a spark gap emitter, piezoelectric emitter, photoacoustic emitter, or ultrasonic emitter. Each emitter is separated from its corresponding reflector by a degassing fluid. The device may feature an interface gel at the surface facing the target. The reflector may be formed by a single reflector along the surface. An imaging system, such as X-ray or ultrasound, may be included to visualize the calcified plaque target. The reflectors are positioned so that the focal point of each reflector aligns with the calcified plaque target. This alignment can be determined using fluorescence or X-ray imaging. The reflectors may be adjustable in at least two directions.

[0009] According to the second example, an extracorporeal lithotripsy device designed to disrupt calcification or other vascular accumulations includes a support structure with a target-facing surface. The extracorporeal lithotripsy device comprises means for emitting a signal from the surface toward the calcified plaque target and means for reflecting the signal toward the target. These means work together in the support structure to deliver a shock wave to the calcified plaque target.

[0010] The target, in this case, may be a calcified plaque located at a certain distance from the surface of the device. The support structure may be in the form of a belt or brace surrounding the calcified plaque target. Means for emitting and reflecting signals may be designed to provide an adjustable peak pressure greater than 20 MPa at the calcified plaque target. Means for emitting signals may be a spark gap emitter, a piezoelectric emitter, a photoacoustic emitter, or an ultrasonic emitter. Multiple means for emitting and reflecting signals may be present, with each emitter separated from its corresponding reflector by a degassing fluid. An interface gel may be applied to the surface facing the target. Imaging systems, such as X-ray or ultrasound, may also be included to visualize the calcified plaque target. Means for reflecting signals may be adjusted to ensure that the focus of each reflector aligns with the calcified plaque target. This adjustment may be based on an X-ray image of the target. Means for reflecting signals may be adjustable in at least two directions.

[0011] According to the third example, the method for extracorporeal lithotripsy involves a step of generating images of the region containing vascular structures. From these images, targets corresponding to calcification or other vascular accumulations in the structures are identified. Subsequently, shock wave therapy is applied to the targets using an extracorporeal device.

[0012] The extracorporeal device used in the method may comprise a support structure with a target-facing surface, multiple lithotomy emitters positioned on the support structure to emit signals from the surface, and multiple lithotomy reflectors positioned adjacent to the emitters on the support structure. These emitters and reflectors function together to deliver signals to the target. The method may also involve performing balloon angioplasty using a drug-coated balloon if necessary. Image generation can be performed through ultrasound imaging or fluoroscopy imaging. Both imaging techniques may be used together. The lithotomy reflectors can be mounted on the support structure, which may be in the form of a belt or brace surrounding the target. The emitters and reflectors are configured to provide an adjustable peak pressure of over 20 MPa at the target. The emitters may be spark gap emitters, piezoelectric emitters, and ultrasonic emitters, and each emitter may be separated from its corresponding reflector by a degassing fluid. An interface gel may be applied to the target-facing surface. The reflectors may be formed by a single reflector along the surface. The target may be imaged during shock wave therapy using X-ray or ultrasound imaging. Reflectors may be positioned so that the focal point of each reflector aligns with the target, based on the generated image of the region.

[0013] The aspects and advantages of the embodiments provided herein are described with reference to the following detailed description, which is associated with the accompanying drawings. Reference numerals may be reused throughout the drawings to indicate correspondences between elements that are referenced. The drawings are provided to illustrate the examples described herein and are not intended to limit the scope of this disclosure. [Brief explanation of the drawing]

[0014] [Figure 1] This is a simplified cross-sectional view of an extracorporeal lithotripsy device. [Figure 2] This is a detailed schematic diagram of a single external crushed stone emitter and its corresponding external crushed stone reflector. [Figure 3] This is a simplified cross-sectional view of an extracorporeal lithotripsy system, including imaging. [Figure 4] This is a simplified side view of a horizontal external lithotripsy device. [Figure 5] This is a flowchart illustrating the procedure for performing extracorporeal lithotripsy. [Modes for carrying out the invention]

[0015] While various embodiments accept various modifications and substitutions, the specifications of the various embodiments are illustrated and described in detail with examples in the drawings. However, it should be understood that there is no intention to limit the claimed invention to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and substitutions that fall within the spirit and scope of the subject matter as defined by the claims.

[0016] Herein, several embodiments of the present invention are described with reference to the accompanying drawings. However, the present invention can be embodied in many different forms and should not be construed as being limited to the embodiments described herein, but rather these embodiments are provided to make this disclosure complete and finished and to fully convey the scope of the invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention.

[0017] The association between vascular calcification and chronic comorbidities, including coronary and peripheral artery disease, is well established. Vascular calcification is a pathological response to toxic irritants accompanied by metabolites and / or inflammatory cells. There are two classifications of vascular calcification: intima and media. Intima-calcification is associated with atherosclerotic plaque. Intima-calcification causes stenotic lesions and impaired blood flow. Impaired blood flow can lead to decreased organ perfusion and ischemia. Medial calcification results from the osteogenic differentiation of vascular smooth muscle cells in the medial layer of the vessel wall. Medial calcification is not associated with luminal occlusion. However, medial calcification causes a decrease in the elasticity and extensibility of the arterial wall, which can ultimately lead to atherosclerosis, decreased perfusion, and ultimately coronary and peripheral artery disease.

[0018] For the purposes of this disclosure, these concepts should be considered as generally interchangeable in referring to the treatment of calcification in vascular structures that can cause reduced blood flow and decreased extensibility of arteries. Stenosis refers to the narrowing of blood vessels due to accumulation and is a medical condition associated with the problem of various substances accumulating in arteries, as outlined earlier. Embodiments of the following devices, methods, and systems are adapted for extracorporeal devices to treat calcification accumulations that are generally very difficult to treat with conventional treatments such as balloon and stent placement.

[0019] The accumulation of hardened substances in blood vessels is a considerable problem, which narrows the blood vessels and causes problems in providing adequate blood flow to the region where stenosis occurs and beyond. One particularly problematic region is the leg region, including the superficial femoral artery (SFA) region at and above the knee, and the popliteal artery at and above the knee. These arteries are particularly large, and stenosis in this region impedes adequate blood flow to the leg and foot, which can lead to numerous problems including the possibility of amputation. Conventional treatment methods outlined earlier in the background section typically utilize interventional devices such as balloons and / or stents placed at the target region. These devices have had mixed results and are not particularly effective against more calcified plaque / sclerotic accumulations.

[0020] Other systems include a generator, a cable, and a disposable catheter with a balloon that incorporates a lithotripsy emitter. The emitter delivers sonic pressure waves to break up calcium, which allows the artery to be dilated at low balloon pressure. This can be a standalone treatment, or it can be used as a first step to treat more calcified plaque, with a balloon or stent subsequently introduced to provide subsequent treatment of the target site. While this approach offers some promise, it is an interventional procedure that carries its own set of risks.

[0021] The devices outlined below and shown in the accompanying figures utilize an electromechanical or electrohydraulic device that is positioned externally around the target region and delivers pulsating forces to the blood vessels in the body beneath the electromechanical device. In some embodiments, the device can be regarded as a belt positioned horizontally or vertically around the target region. The device has particular practical utility for the treatment of calcification in the SFA and popliteal arteries, and especially in the below-knee region where current techniques have difficulty in treating, but the device can be used at various locations where there is calcification in the vasculature.

[0022] Lithotripsy utilizes sinusoidal curves (acoustic shock waves), and the generated pressure pulsations are involved in breaking calcifications. This technique has been used in the past to treat kidney stones or urinary tract stones. A typical shock wave begins with an almost instantaneous surge to a peak positive pressure of 30 MPa to 110 MPa. This rapid transition in the waveform is referred to as a shock. The transition is immeasurably fast, with a duration of less than 5 ns. The pressure then drops to zero, followed by a negative pressure trough (tension wave). Intense compression waves induce mechanical forces inside the stone that can cause fragmentation. Current-generation shock wave lithotripsy systems are equipped with a built-in adjustable isocentric fluoroscopic C-arm (X-ray) and lateral ultrasound (optionally available in a dual localization system) for stone localization.

[0023] Current intravascular lithotripsy leverages these techniques in an intravascular scenario where a pulsation-generating device is physically introduced into a blood vessel. Current intravascular lithotripsy uses pulsating acoustic pressure waves that pass through soft tissue, selectively and strongly interact with high-density calcium in arteries, and generate considerable shear stress capable of breaking the calcium. The system consists of a generator, a connector cable, and a catheter that houses an array of lithotripsy emitters enclosed in an integrated balloon.

[0024] One problem is identifying target pressures and target frequencies that can treat pathological conditions without damaging soft tissue. For extracorporeal lithotripsy for urinary stone applications, considerable pressure is required because these stones are dense and quite large. Studies have proposed peak pressures of about 20 MPa to 110 MPa, with a delivery frequency of about 1 Hz to 1.5 Hz and about 2000 to 3000 shock waves, 1 mJ / mm 2 ~5mJ / mm 2 is required. At this delivery frequency, long-term soft tissue damage is typically not observed.

[0025] For the purposes of coronary and peripheral artery disease, a peak pressure of about 3 to 5 MPa, 0.1 to 0.3 mj / mm 2However, this is considered preferable for inducing angiogenesis and reducing calcification. Multiple sessions in this range, with approximately 3 sessions per week for 3 weeks, involving 200 shots per site, were observed to treat the targeted condition without damaging the tissue.

[0026] For endovascular lithotripsy in the SFA, a peak pressure of approximately 5 MPa introduced through a pulsating balloon was observed to break up calcifications. A single session of at least 30 pulsations of approximately 1 millisecond at approximately 1 Hz, with pulsations ranging from approximately 30 to 180 times, was observed to treat calcifications in the SFA without damaging soft tissue.

[0027] Embodiments of lithotomy considered herein utilize an extracorporeal lithotomy device in the form of a vertical or horizontal belt positioned around a target area. In one embodiment, the lithotomy device is used to treat calcification in the area of ​​the knee or leg and takes the form of a knee brace or belt that delivers focused, pulsating energy to the calcified plaque. In one embodiment, pulsating shock waves are used to deliver this energy. The goal of the device is to weaken or break calcium deposits in peripheral arteries, either as a standalone treatment or to improve the effectiveness of subsequent treatments such as balloon angioplasty, drug-coated angioplasty, and / or endovascular stent placement. The device incorporates a lithotomy emitter and a lithotomy reflector that can externally impart pulsating energy and reach the target vascular area. In one embodiment, a water medium captures the emitter for efficient transmission of shock waves to the body. In various embodiments, various methods may be used to impart pulsating force, such as spark gaps, piezoelectric transmitters, and ultrasonic systems.

[0028] Figure 1 shows an embodiment of an extracorporeal lithotomy device 100 that can be used for disrupting calcification or other vascular accumulations. The extracorporeal lithotomy device 100 includes a support structure 102. The support structure 102 is positioned around a target calcified plaque target 104. Between the support structure 102 and the calcified plaque target 104 are bone 106, muscle 108, and vascular structure 110. For example, bone 106 could be the tibia, muscle 108 could be the calf muscle, and vascular structure 110 could be a peripheral artery containing the calcified plaque target 104.

[0029] The extracorporeal lithotomy device 100 may extend around the calcified plaque target 104, such as in the form of a ring around bone 106, muscle 108, and vascular structures 110, as shown in Figure 1. For example, the support structure 102 may be a belt or brace that fits around the patient at the calcified plaque target 104 in some embodiments.

[0030] The radially inward edge of the support structure 102 of the extracorporeal lithotripsy device 100 is shown as the target-facing surface 112. The target-facing surface 112 is the interface between the extracorporeal lithotripsy device 100 and the patient. The target-facing surface 112 may be, for example, the radially inward surface of a belt that comfortably fastens the extracorporeal lithotripsy device 100 to the patient, so that it acts as a good acoustic shock wave connector with the patient.

[0031] In addition to the support structure 102, the external crushing device 100 comprises a plurality of crushing emitters 114. Each of the plurality of crushing emitters 114 shown in Figure 1 is paired with a corresponding one of a plurality of crushing reflectors 116 positioned adjacent to one of the plurality of crushing emitters 114. In the configuration shown in Figure 1, each of the plurality of crushing emitters 114 is separated and clearly distinguishable from the others, and each of the plurality of crushing reflectors 116 is separated and clearly distinguishable from one another. However, in alternative configurations, this may not always be the case. For example, a single reflective parabolic depression may function as a crushing reflector for multiple of the plurality of crushing emitters 114, or in fact for all of the crushing emitters 114. Similarly, a wavy pattern may be used, using a single component or part of reflective material, to function as a crushing reflector for multiple of the plurality of crushing emitters 114.

[0032] Each of the multiple lithotripsy emitters 114 can generate a shock wave pulsation. In the embodiment, the shock wave travels through the patient to the target and, at the target, has sufficient pressure to remain strong enough to cause calcium fracture. As previously described, it has been found that an intravenous pressure of about 5 MPa in the shock wave pulsation is sufficient when the shock wave pulsation arrives at the calcified plaque target 104 to cause the calcified plaque target 104 to fracture. Conversely, a sufficiently high shock wave pulsation can cause discomfort or injury to the patient. However, it has been found that there is a range of pulsation intensities that can produce a sufficiently high pressure pulsation at the calcified plaque target 104 without causing discomfort or injury. Therefore, it is often the case that multiple lithotripsy emitters 114 generate a shock wave pulsation of about 100 MPa. For example, the shock wave of extracorporeal lithotripsy formed by multiple lithotripsy emitters 114 may be between approximately 20 MPa and 300 MPa, or more preferably between approximately 20 MPa and 100 MPa for low-pressure applications, or between approximately 100 MPa and 300 MPa for high-pressure applications.

[0033] To generate such shock waves, in some embodiments, the multiple crushed stone emitters 114 may be spark gap emitters, piezoelectric emitters, and ultrasonic emitters, respectively. For example, in one embodiment, a 30kV spark gap emitter can be used to generate a suitable pressure pulsation of at least 100MPa.

[0034] Multiple crushed stone reflectors 116 facilitate the provision of sufficient pressure to the calcified plaque target 104. The amount of energy that must be expended in the multiple crushed stone emitters 114 to provide sufficient pressure in the shock wave at the calcified plaque target 104 may depend in part on the expected attenuation of the signal on its way to the calcified plaque target 104. This efficiency is at least in part on the efficiency of the initial shock wave being focused. Multiple crushed stone reflectors 116 may be reflective to the shock wave. The portion of the acoustic shock wave produced by the multiple crushed stone emitters that would otherwise travel away from the calcified plaque target 104 is redirected and / or focused toward the calcified plaque target 104. Multiple crushed stone reflectors 116 may be semicircular, parabolic, or other shapes in order to focus the signal generated by the multiple crushed stone emitters 114 toward the calcified plaque target 104.

[0035] As shown in Figure 1, the multiple agglomerate emitters 114 and their corresponding multiple agglomerate reflectors 116 do not need to align along the entire ring formed by the support structure 102. In this embodiment, for example, the multiple agglomerate emitters 114 and their corresponding multiple agglomerate reflectors 116 do not extend around the portion of the support structure through which the signals generated from them travel through the bone 106. Differences in material (e.g., from bone to muscle, or from muscle to fat, or through blood) can cause diffraction, distortion, or attenuation of the acoustic or shock wave signals. Thus, signals passing through material discontinuities may arrive at the calcified plaque target 104 either heavily attenuated, in the wrong location, or, worse, in a phase mismatch with signals from other agglomerate emitters 114 that cause canceling interference. Therefore, in this embodiment, it may be preferable to position the multiple agglomerate emitters 114 and multiple agglomerate reflectors 116 in locations where the intensity, direction, and timing of the signals generated from them are more predictable.

[0036] Multiple alithotripsy emitters 114 are positioned such that their paired alithotripsy reflectors 116 are focused on the calcified plaque target 104. A support structure 102 holds the multiple alithotripsy emitters 114 and the multiple alithotripsy reflectors 116 in place to provide signals from them to the calcified plaque target 104. In some embodiments, the support structure 102 may be customized to receive the multiple alithotripsy emitters 114 and the multiple alithotripsy reflectors 116 in desired positions and orientations based on the known position of the calcified plaque target 104 acquired in an imaging scan, such as an ultrasound or fluoroscopy image. In such embodiments, the support structure 102, the multiple alithotripsy emitters 114, and / or the multiple alithotripsy reflectors 116 may be customized for a customized therapeutic procedure, such as by 3D printing or by manual placement by a technician.

[0037] Additionally, some components of the extracorporeal lithotripsy device 100 may be replaceable or repairable. Multiple lithotripsy emitters 114 may be replaced after a certain length of use, for example, in the case of spark gap emitters that have the maximum usable service life.

[0038] The extracorporeal lithotripsy device 100 in Figure 1 can be operated by supplying power to multiple lithotripsy emitters 114 to generate acoustic signals (e.g., acoustic shock waves). The multiple lithotripsy emitters 114 can be powered simultaneously or in coordination with each other, such as with a predetermined delay, to bring sufficient pressure to the calcified plaque target 104 for fracture.

[0039] As a result, there is no need for invasive or intravascular treatment required for fracture of the calcified plaque target 104. Treatment with the extracorporeal lithotripsy device 100 is faster, safer, and more efficient than conventional techniques involving balloon catheters, etc.

[0040] Figure 2 is a detailed schematic diagram of a single external crushed stone emitter 114 and a corresponding crushed stone reflector 116. The same components as those previously described in Figure 1 are shown in Figure 2. Throughout this application, where similar components are shown in multiple figures, similar components share reference numerals or have reference numerals that are repeated 100 times. Descriptions of components previously described are not repeated in subsequent figures, and it should be understood that descriptions from earlier figures apply to later figures unless otherwise explicitly stated.

[0041] As shown in Figure 2, a single crushed stone emitter is positioned on a support structure 102 having a target-facing surface 112. However, the calcified plaque target 104 is far from the target-facing surface 112. The crushed stone emitter 114 produces a shock wave that is focused by a crushed stone reflector 116 to become a signal 218. The signal 218 travels along a distance 220 between the target-facing surface 112 and the calcified plaque target 104. The focal point 222 of the signal 218 is substantially located on the calcified plaque target 104. In the context of this disclosure, “substantially” refers to the calcified plaque target 104 or within it, such that the peak pressure for calcium fracture is applied to the calcified plaque target 104. The focal point 222 may also be referred to as the focal region, since the focus of the acoustic shock wave signal does not fall on a precise point; therefore, the focal point 222 may refer to a region that substantially overlaps the calcified plaque target 104. In other words, this substantially overlaps when the region in which a focused acoustic pressure shock wave is strong enough to break through the calcium includes at least a portion of the calcified plaque target 104.

[0042] The space between the crushed stone emitter 114 and the crushed stone reflector 116 is filled with a material having suitable acoustic transmission properties to provide low energy loss to a well-focused shock wave signal. For example, the space between the crushed stone emitter 114 and the crushed stone reflector 116 may be filled with a degassing fluid 224. Although not depicted in Figure 2, the crushed stone emitter 114 and the crushed stone reflector 116 can be housed in a module filled with the degassing fluid 224, and the module may be inserted into the support structure 102 either permanently or replaceably.

[0043] Some of the arrows in Figure 2 point to adjustments that can be made in a particular embodiment. For example, intersecting arrows point to the mobility of the crushed stone emitters 114 and crushed stone reflectors 116, either from side to side or left to right relative to the plane of the paper. Positioning the crushed stone emitters 114 and crushed stone reflectors 116 on the support structure 102 may affect where the focus 222 is positioned. Not only is the focus 222 set to overlap the calcified plaque target 104, but in embodiments, the focus 222 of each of the multiple crushed stone emitters 114 and their corresponding multiple crushed stone reflectors 116 may be adjusted so that the same or substantially the same focus 222 is targeted in order to increase the breaking pressure.

[0044] The double arrows in Figure 2 illustrate possible modifications to one of the multiple crushed stone reflectors 116 depicted. The focal point 222 will change depending on the level of curvature of the multiple crushed stone reflectors 116. If the distance 220 from the target-facing surface 112 to the calcified plaque target 104 is large, it may be desirable to have shallower multiple crushed stone reflectors 116 with correspondingly larger focal points 222, and vice versa. In this way, the multiple crushed stone reflectors 116 are adjustable either individually or as a set.

[0045] As can be understood from the above, the multiple crushed stone emitters 114 and the multiple crushed stone reflectors 116 can be modified in several ways for different uses. For example, if the calcified plaque target 104 is in the thigh at a very deep depth, then the focus 222 can be set at a large distance 220 by changing the curvature of the multiple crushed stone reflectors 116 to be relatively shallower. On the other hand, the multiple crushed stone emitters 114 can be configured to generate a large power output to account for the expected signal dissipation over a larger distance 220.

[0046] Conversely, if the calcified plaque target 104 is very shallow, such as in the calf or forearm, the focus 222 can be set at a smaller distance 220 by changing the curvature of the multiple aggravated reflectors 116 to be relatively high. On the other hand, the multiple aggravated emitters 114 can be configured to create a smaller power output, since the same power is not required to create sufficient pressure toward the fracture of calcium in the calcified plaque target 104.

[0047] Figure 3 shows an extracorporeal lithotripsy system 300, which includes an extracorporeal lithotripsy device (such as the extracorporeal lithotripsy system 100 in Figure 1), as well as an interface gel 326 and an imaging system 328.

[0048] The interface gel 326 is positioned between the support structure 302 and the main body along the target-facing surface 312. The interface gel 326 can form better shock wave transmission between the extracorporeal lithotripsy system 300 and the main body. Providing the interface gel 326 in this area facilitates the transmission of pressure waves generated by multiple lithotripsy emitters 314, focused by multiple lithotripsy reflectors 316, toward the calcified plaque target 304, compared to the absence of the interface gel 326. While the interface gel 326 is commonly used for imaging and other acoustic shock wave coupling purposes, it should be understood that any interface material, such as a non-gel fluid, may be used in alternative embodiments.

[0049] The imaging system 328 is provided around the rest of the extracorporeal lithotomy system 300 and can be used to determine the location, size, or condition of the calcified plaque target 304 as well as the location, size, or condition of other anatomical features such as bone 306 and muscle 308. Therefore, the imaging system 328 can be used to provide information that influences positioning, targeting, and power levels used by the multiple lithotomy emitters 314 and the corresponding multiple lithotomy reflectors 316. In some embodiments, the imaging system 328 may be specifically positioned to image the calcified plaque target 304. The imaging system may be an X-ray imaging system.

[0050] Figure 4 shows an extracorporeal lithotomy device 400 in a horizontal array. In Figures 1-3, the lithotomy emitters are positioned along at least a portion of a ring around the target. However, in some cases, the calcified plaque target 404 may extend along the body, such as through an artery that runs along the length of a leg. In such cases, the extracorporeal lithotomy device 400 in a horizontal array can treat a larger portion of the calcified plaque target 404 than can be achieved by devices in the form of rings or belts.

[0051] The horizontally arranged extracorporeal lithotomy device 400 includes a support structure 402 that extends linearly along the body. The horizontally arranged extracorporeal lithotomy device 400 also includes a strap 403 attached to the support structure 402 and the patient in order to maintain the support structure 402 in a fixed position relative to the calcified plaque target 404. Thereafter, multiple lithotomy emitters 414 and their corresponding multiple lithotomy reflectors 416 are arranged to provide acoustic pulsations or shock waves along the length of the calcified plaque target 404.

[0052] Figure 4 also depicts the voltage supply unit 430. The voltage supply unit 430 supplies power to multiple crushed stone emitters 414. A similar voltage supply can be used in the embodiments described in relation to Figures 1 to 3.

[0053] The voltage supply unit 430 may include a control circuit, a power supply unit, a capacitor bank, and a trigger signal generator to provide bursts of power to the multiple crushed stone emitters 414. In embodiments, the voltage supply unit 430 may include a circuit to adjust the operation of the multiple crushed stone emitters 414 so that they emit simultaneously, or so that they emit with a desired delay relative to one another to constructively interfere their pressure waves at the calcification plaque target 404.

[0054] The voltage supply unit 430 may be a high-voltage power supply unit of approximately 30,000 volts. DC power can be connected to the electrodes and controlled by a triggered spark gap. An array of high-voltage capacitors is mounted along the DC power supply output line to provide the large current required to evaporate water across the electrodes in the reflector.

[0055] A 24Vdc power supply can be connected to the primary side of an automotive spark plug coil serving as a crushed stone emitter. To activate the system, a switch is pressed, allowing the initial field to collapse, including a high-voltage pulsation on the secondary side of the coil. This pulsation connects to a triggered spark gap, which creates an ionization field that discharges the stored 30,000Vdc toward shock wave generation. Using this technique, more than 10,000 amperes can be discharged across immersed electrodes in less than one millisecond.

[0056] In one embodiment, as previously described, a spark gap system is used, in which multiple emitters and reflectors are separated by a degassing fluid that acts as a conductive fluid between the various emitters and reflectors. An electric current is generated between the electrodes, creating a pulsating spark. Water fills the empty spaces in the device to provide other conductive fluid media. A surface gel may be further used to minimize the gap between the skin and the device.

[0057] The devices, systems, and methods, along with their various components, are illustrative examples shown in the attached diagrams. The power used to create the plasma field was measured at 30,000 V / 10,000 Amp, resulting in shock wave pulsations of up to 300 MPa, and was measured using an optical fiber hydrophone.

[0058] Figure 5 shows method 500 for extracorporeal lithotomy. According to method 500, the patient is optionally scheduled for peripheral artery intervention, as indicated by reference numeral 502. Ultrasonography or CT scan may be performed in preparation for peripheral artery intervention, as indicated by reference numeral 504. Based on the ultrasound in reference numeral 504, a diagnosis of the peripheral arteries may be formed. Additionally or alternatively, the peripheral arteries may be imaged using fluoroscopy, such as with lateral projection, as indicated by reference numeral 506.

[0059] In reference numeral 508, shock wave therapy is performed. Although not shown in Figure 5, the method may further include creating or modifying an extracorporeal lithotripsy device, such as those described with respect to Figures 1-4, which are appropriate for the shock wave therapy in reference numeral 508. Forming or modifying the device may include, for example, adjusting the focal depth, power output, or position of the lithotripsy emitter in the support structure. Shock wave therapy 508 may be performed with an appropriate number of pulses to break up calcium in the target.

[0060] In reference to 510, the patient may undergo angiography, such as drug-coated balloon angiography. Optionally, the angiography in reference to 510 may be performed while the shock wave therapy in reference to 508 is still being performed.

[0061] Once the shock wave therapy 508 and / or angiogenesis 510 is complete, the patient is released at reference numeral 512. Through any or all of the elements of method 500, imaging may be performed using an X-ray imaging system such as the one depicted in Figure 3.

[0062] The above disclosure describes several extracorporeal lithotripsy devices that can be used to treat calcified plaque buildup in blood vessels. These devices may comprise a support structure, a lithotripsy emitter, and a lithotripsy reflector. The device may be worn as a belt or brace around a target area, such as the leg or knee, where the calcified plaque is narrowing the vessel and reducing blood flow. The advantage of these devices is that they provide a non-invasive treatment option for calcified plaque, which is typically difficult to treat with conventional methods such as balloons and stents. The device delivers focused, pulsating energy externally to the calcified plaque without requiring invasive procedures. The device uses shock wave pulsations produced by the lithotripsy emitter to weaken or break up calcium deposits in the blood vessel.

[0063] By targeting calcified plaques, the devices described herein can improve blood flow, prevent further complications, and reduce the need for amputation in severe cases. The devices may be used as a standalone treatment or in combination with other interventions such as balloon angioplasty or stent placement. The devices may be customized and adjusted based on the location and characteristics of the calcified plaques. The position, orientation, and power level of the lithotomy emitter and reflector may be modified to precisely focus acoustic shock wave pulsations onto the target area. In some cases, the devices include an imaging system to guide the treatment and to evaluate the effectiveness of the procedure, as well as an interface gel to enhance the transmission of acoustic shock waves between the device and the body. This extracorporeal lithotomy device offers unique advantages due to its non-invasiveness, effectiveness against calcified plaques, customization for different target areas, and potential to improve blood flow and prevent further complications associated with reduced blood flow and arterial extensibility.

[0064] This disclosure describes several examples of the art with reference to the accompanying drawings, and only a few of the possible examples are shown. However, other embodiments can be embodied in many different forms and should not be construed as being limited to the examples described herein. Rather, these examples are provided to fully convey to those skilled in the art the scope of possible examples, as this disclosure is complete and finished.

[0065] While specific examples are described herein, the scope of this technology is not limited to these specific examples. Those skilled in the art will recognize other examples or improvements within the scope of this technology. Therefore, certain structures, actions, or media are disclosed only as illustrative examples. Examples of this technology may also combine elements or components of generally disclosed technologies, unless otherwise stated, but are not expressly illustrated in such combinations. The scope of this technology is defined by the following claims and any equivalents. [Explanation of symbols]

[0066] 100 Extracorporeal lithotripsy devices, extracorporeal lithotripsy systems 102 Support structure 104 Calcified plaque targets 106 bones 108 Muscles 110 Vasculature 112 Surface facing the target 114 Crushed stone emitter 116 Crushed stone reflector 218 Signal 220 distance 222 Focus 224 Degassed fluid 300 Extracorporeal Lithotripsy System 302 Support structure 304 Calcified plaque target 312 Surface facing the target 314 Crushed stone emitter 316 Crushed stone reflector 326 Interface gel 328 Imaging Systems 400 Extracorporeal Lithotomy Devices 402 Support structure 403 Strap 404 Calcified plaque target 414 Crushed stone emitter 416 Crushed stone reflector 430 Voltage supply unit

Claims

1. An extracorporeal crushing device for disrupting calcification, A support structure having a surface facing the target, Multiple crushed stone emitters are arranged in the support structure to emit a signal from the surface facing the target, A plurality of crushed stone reflectors arranged adjacent to the crushed stone emitter in the support structure, wherein the plurality of crushed stone emitters and the plurality of crushed stone reflectors are configured to deliver the signal to a calcified plaque target that is a distance away from the external crushed stone device from the surface facing the target, An extracorporeal lithotomy device equipped with the following features.

2. The extracorporeal lithotripsy device according to claim 1, wherein the support structure is a belt or brace extending in a loop around the calcified plaque target.

3. The extracorporeal agglomeration device according to claim 1 or 2, wherein the plurality of agglomerate emitters and the plurality of agglomerate reflectors are configured to provide an adjustable peak pressure at the calcified plaque target.

4. The extracorporeal lithotripsy device according to claim 3, wherein the peak pressure is greater than 100 MPa.

5. The extracorporeal crushing device according to any one of claims 1 to 4, wherein the plurality of crushed stone emitters are selected from the group consisting of spark gap emitters, piezoelectric emitters, photoacoustic emitters, and ultrasonic emitters.

6. An extracorporeal crushing device according to any one of claims 1 to 5, wherein each of the plurality of crushed stone emitters is separated from a corresponding one of the plurality of crushed stone reflectors by a degassing fluid.

7. An extracorporeal lithotripsy device according to any one of claims 1 to 6, further comprising an interface gel disposed on the surface facing the target.

8. The extracorporeal crushing device according to any one of claims 1 to 7, wherein the plurality of crushed stone reflectors are formed by a single reflector arranged along the surface facing the target.

9. The extracorporeal lithotripsy device according to any one of claims 1 to 8, further comprising an imaging system arranged to image the calcified plaque target.

10. The extracorporeal lithotomy device according to claim 9, wherein the imaging system is an X-ray imaging system.

11. The extracorporeal lithotomy device according to claim 9, wherein the imaging system is an ultrasonic imaging system.

12. The extracorporeal abrasive device according to any one of claims 1 to 11, wherein the plurality of abrasive reflectors are arranged such that the focal point of each of the plurality of abrasive reflectors is substantially on the calcified plaque target.

13. The extracorporeal agglomeration device according to any one of claims 1 to 12, wherein the plurality of agglomerate reflectors are held by the support structure such that the focal point of each of the plurality of agglomerate reflectors is determined according to a fluorescence image of the calcified plaque target.

14. The extracorporeal agglomeration device according to any one of claims 1 to 13, wherein the plurality of agglomeration reflectors are held by a support such that the focal point of each of the plurality of agglomeration reflectors is determined according to the X-ray image of the target.

15. The extracorporeal crushing device according to any one of claims 1 to 14, wherein each of the plurality of crushed stone reflectors is adjustable in at least two directions.

16. An extracorporeal lithotomy device for disrupting calcification or other vascular accumulations, A support structure having a surface facing the target, Means for emitting a signal from the surface facing the target toward the calcified plaque target, The support structure is provided with means for reflecting the signal toward the calcified plaque target, Equipped with, An extracorporeal lithotripsy device, wherein the means for emitting the signal and the means for reflecting the signal are configured to cooperate in delivering a shock wave to the calcified plaque target.

17. The extracorporeal lithotripsy device according to claim 16, wherein the target is a calcified plaque that is separated from the extracorporeal lithotripsy device at a certain distance from the surface facing the target.

18. The extracorporeal lithotripsy device according to claim 16 or 17, wherein the support structure is a belt or brace extending in a loop around the calcified plaque target.

19. The extracorporeal lithotripsy device according to any one of claims 16 to 18, wherein the means for emitting the signal and the means for reflecting the signal are configured to provide an adjustable peak pressure in the calcified plaque target.

20. The extracorporeal lithotripsy device according to claim 19, wherein the peak pressure is greater than 20 MPa.

21. The extracorporeal lithotripter according to any one of claims 16 to 20, wherein the means for emitting the signal is selected from the group consisting of a spark gap emitter, a piezoelectric emitter, a photoacoustic emitter, and an ultrasonic emitter.

22. The means for emitting the signal includes a plurality of means for emitting the signal, The means for reflecting the signal toward the calcified plaque target includes a plurality of means for reflecting the signal toward the calcified plaque target, An extracorporeal lithotripsy device according to any one of claims 16 to 21, wherein each of the plurality of means for emitting the signal is separated by a degassing fluid from the corresponding means for reflecting the signal toward the calcified plaque target.

23. The extracorporeal lithotripsy device according to any one of claims 16 to 22, further comprising an interface gel disposed on the surface facing the target.

24. The extracorporeal lithotripsy device according to any one of claims 16 to 23, further comprising an imaging system arranged to image the calcified plaque target.

25. The extracorporeal lithotripsy device according to claim 24, wherein the imaging system is an X-ray imaging system.

26. The extracorporeal lithotomy device according to claim 24, wherein the imaging system is an ultrasonic imaging system.

27. The extracorporeal lithotripsy device according to any one of claims 16 to 26, wherein the means for reflecting the signal toward the calcified plaque target is arranged such that the focal point of each of the plurality of means for reflecting the signal toward the calcified plaque target is substantially located toward the calcified plaque target.

28. The extracorporeal lithotripsy device according to claim 27, wherein the means for reflecting the signal toward the calcified plaque target is held by the support structure such that the focal point of each of the plurality of means for reflecting the signal toward the target is determined according to an X-ray image of the calcified plaque target.

29. The extracorporeal lithotripsy device according to any one of claims 16 to 28, wherein the means for reflecting the signal toward the calcified plaque target is adjustable in at least two directions.

30. A method for extracorporeal lithotripsy, A step of generating an image of the region including vascular structures, The steps include identifying targets corresponding to calcification or other vascular accumulation in the vascular structure, The steps include applying shock wave therapy to the target using an extracorporeal device, Methods for extracorporeal lithotripsy, including those mentioned above.

31. The aforementioned extracorporeal device is A support structure having a surface facing the target, Multiple crushed stone emitters are arranged in the support structure to emit a signal from the surface facing the target, A plurality of crushed stone reflectors arranged adjacent to the crushed stone emitter in the support structure, wherein the plurality of crushed stone emitters and the plurality of crushed stone reflectors are configured to deliver the signal to the target, A method for extracorporeal lithotomy according to claim 30, comprising:

32. A method for extracorporeal lithotripsy according to claim 30 or 31, further comprising the step of performing balloon angioplasty.

33. The method for extracorporeal lithotomy according to claim 32, wherein the balloon angioplasty is performed using a drug-coated balloon.

34. The method for extracorporeal lithotomy according to any one of claims 30 to 33, wherein the step of generating the image includes generating an ultrasound image.

35. The method for extracorporeal lithotomy according to any one of claims 30 to 34, wherein the step of generating the image comprises generating a fluorescence fluoroscopy image.

36. The method for extracorporeal lithotripsy according to claim 34 or 35, wherein the step of generating the image includes generating both an ultrasound image and a fluoroscopic image.

37. The method for extracorporeal lithotomy according to any one of claims 30 to 36, further comprising mounting a plurality of lithotripsy reflectors on a support structure, wherein the support structure comprises a belt or brace extending in a loop around the target.

38. A method for extracorporeal lithotomy according to any one of claims 30 to 37, wherein a plurality of lithotripsy emitters and a plurality of lithotripsy reflectors are configured to provide an adjustable peak pressure at the target.

39. The method for extracorporeal lithotripsy according to claim 38, wherein the peak pressure is greater than 20 MPa.

40. A method for extracorporeal lithotripsy according to any one of claims 30 to 39, wherein the plurality of lithotripsy emitters are selected from the group consisting of spark gap emitters, piezoelectric emitters, and ultrasonic emitters.

41. A method for extracorporeal lithotripsy according to any one of claims 30 to 40, wherein each of a plurality of crushed stone emitters is separated from a corresponding one of a plurality of crushed stone reflectors by a degassing fluid.

42. A method for extracorporeal lithotripsy according to any one of claims 30 to 41, further comprising the step of applying an interface gel to the surface facing the target.

43. A method for extracorporeal lithotripsy according to any one of claims 30 to 42, wherein the plurality of lithotripsy reflectors are formed by a single reflector positioned along the surface facing the target.

44. A method for extracorporeal lithotripsy according to any one of claims 30 to 43, further comprising the step of imaging the target during the shock wave treatment.

45. The method for extracorporeal lithotomy according to claim 44, wherein the step of imaging the target during the shock wave treatment includes X-ray imaging the target.

46. The method for extracorporeal lithotomy according to claim 44, wherein the step of imaging the target during the shock wave treatment includes ultrasound imaging of the target.

47. A method for extracorporeal lithotripsy according to any one of claims 30 to 46, further comprising the step of arranging the plurality of alith reflectors such that the focal point of each of the plurality of alith reflectors is substantially on the target according to the generated image of the region.

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