WO2023286056A1

WO2023286056A1 - Device and system for generating an acoustic energy waveform having shockwave bursts

Info

Publication number: WO2023286056A1
Application number: PCT/IL2022/050748
Authority: WO
Inventors: Eduard PAPIROV; Sela SHEFY; Gil Hakim
Original assignee: Armenta Ltd.; Hi Impacts Ltd.
Priority date: 2021-07-12
Filing date: 2022-07-12
Publication date: 2023-01-19
Also published as: IL284802A

Abstract

A system that generates an acoustic energy waveform and in particular a ballistic collision device and system configurable to generate an acoustic energy waveform having shockwave bursts.

Description

DEVICE AND SYSTEM FOR GENERATING AN ACOUSTIC ENERGY WAVEFORM HAVING SHOCKWAVE BURSTS

FIELD OF THE INVENTION

The present invention relates to a device and system that generate an acoustic energy waveform and in particular a ballistic collision device and system configurable to generate an acoustic energy waveform having shockwave bursts.

BACKGROUND OF THE INVENTION

Acoustic energy in its various forms has varied uses in the medical industry including both diagnostic and therapeutic applications. Acoustic energy may come in the form of ultrasound, shockwaves, or radial waves, that have been put to extensive use in medicine. For example, medical imagery in the form of ultrasound is a commonly used form of acoustic energy. A therapeutic form of acoustic energy is also found in shockwaves used for example for triggering angiogenesis, osteogenesis, wound healing, lithotripsy kidney stone fragmentation, and the like.

A shockwave is a form of acoustic energy resulting from a phenomenon that creates a substantially instantaneous intense change in pressure, for example as seen following an explosion or lightning. The intense change in pressure produces strong energy waves that can travel through various mediums such as gases, liquid, solids, air, water, human soft tissue, bone, metals, and the like. The waveform or signal of the shockwave pulse is characterized by a single positive peak followed by low negative peak. Such a shockwave pressure waveform and/or signal is adept at treating a single localize focal area and/or zone.

SUMMARY OF THE INVENTION

State of the art shockwave generating devices utilize various methods and system to generate a shockwave waveform and/or signal. For example, electrohydraulic, spark-gap, piezoelectric, ballistic, and electromagnetic, are all different types of systems that may be equally utilized to generate a shockwave signal. However, irrespective of the method utilized to generate the shockwave waveform, an individual (single) shockwave generating event correlates to a single shockwave pressure waveform and/or signal. Therefore, current systems and method for generating shockwaves are based on a one to one ratio between a generating and/or triggering event to the number of shockwave pulses formed in the treatment area.

Accordingly, so as to generate therapeutic levels of acoustic energy in the form of shockwaves at a targeted tissue site, state of the art shockwave generating device(s), must utilized many shockwave generating events to generate many shockwave signals in a one to one ratio. One generating event for each individual therapeutic shockwave signal.

Therefore, while state of the art shockwave treatment devices are capable of selectively targeting tissue sites and controlling the energy levels that are delivered to the specific site, however, each individual shockwave generating event can only produce a single shockwave treatment signal. Accordingly, state of the art shockwave treatment devices function in a one to one ratio such that one shockwave generating event, irrespective of the technology that is used to generate the shockwave, leads to a single and/or individual therapeutic shockwave treatment signal. For example, state of the art ballistic shockwave devices generate a single shockwave waveform, single peak, from a single ballistic collision. The single shockwave is furthermore limited in terms of its therapeutic contribution, in that the size and depth of the tissue being treated is limited.

Moreover, due to the one to one relationship discussed above, state of the art shockwave systems are limited in the area and depth of tissue that may be treated. That is, state of the art systems are inherently limited to treating small focal zones, and in particular for treatment zones that are disposed at a distance from the treatment surface, namely skin.

Despite its current uses acoustic energy applications remain limited in terms of delivering sufficient acoustic energy at variable and/or extended tissue depths and in particular to treatment sites that have a large area. State of the art devices require many shockwave generating events to generate the corresponding amount of therapeutic shockwave signals.

Furthermore, current acoustic energy devices are limited in that they cannot provide a shockwave energy waveform and/or signal that balances the delivered energy level and the corresponding tissue penetration depth and/or area. Specifically, a persistent problem in the art is the lack of fine control of the amount of acoustic energy that is made available at increasing tissue penetration depths and increasing treatment area. Accordingly with current state of the art shockwave treatment devices, in order to cover large tissue depth and area, a large amount of shockwave generating events are required to work in concert and over an extended time frame. This is due to the fact that each shockwave generating events results in a single shockwave for a single focal zone having a limited treatment area. Accordingly, the one event to one signal to one focal zone ratio provided by state of the art devices and system is not capable of producing a shockwave energy waveform that is capable to treat a treatment area that is both deep and wide (large area at increasing depth) in an efficient manner or over an efficient period of time.

State of the art medical acoustic energy systems are additionally limited in fine control of the levels of acoustic energy available at increasing tissue depths. Such that control of the therapeutic acoustic energy level at increasing depths is currently not readily possible with state-of-the-art devices, due to the one to one relationship described above. To overcome this problem with existing state of the art acoustic energy systems, one would need to simultaneously change, the energy level, location of the applicator of the waves, use multiple applicators and/or change their shape.

Current systems can only reach increased tissue depth by utilizing a large amount of energy and therefore can only deliver a large amount of acoustic energy at increased tissue depths. Such systems do not allow to fine tune and/or control the amount of acoustic energy delivered at deep tissue or over a large treatment area, particularly when the required energy density needed is narrow banded. Therefore, state of the art device provides an all or nothing approach for providing shockwave therapy at increasing tissue depths. However, some therapeutic uses of acoustic energy require low energy amounts at increased tissue depths and/or area. State of the art acoustic energy systems do not provide such low energy availability at increased tissue depth and/or area.

There is an unmet need for, and it would be highly useful to have, a device and system for generating controllable acoustic energy waveform that can deliver controllable amount of acoustic energy to tissue at variable tissue depths and/or treatment area.

Embodiments of the present invention overcome the limitation of the state-of- the-art devices by providing a device and system configured to generate an acoustic energy waveform capable of producing at least two or more shockwave bursts, pressure peaks, from a single ballistic generating event, for example in the form of a collision, wherein the ballistic generating event is controlled based on at least one or more parameters defined by the ballistic impact properties (ratios). Accordingly, when utilizing at least one or more ballistic impact parameter ratios according to the present invention, a single ballistic collision provides for generating and propagating an acoustic energy waveform having at least two or more shockwave bursts. Accordingly, such a burst of shockwave activity from a single ballistic impact is not possible with state-of-the-art shockwave devices.

In embodiments, the device and system of the present invention provide for generating an acoustic energy waveform characterized in that the waveform comprises at least two or more shockwave bursts each burst having an individual peak pressure. The acoustic energy waveform according to embodiments of the present invention is provided by implementing a controllable and unique ballistic collision and/or controlling at least one or more ballistic mechanical property between a projectile and an acoustic energy generating surface.

In embodiments the present invention provides a ballistic acoustic energy generating system comprising: a mobilizing module, a projectile, an accelerator, a generating surface, and a propagating surface.

In some embodiments, the ballistic system may further comprise at least one or more selected from a flow controller, a reload module, an electronics module or the like.

An embodiment of the present invention provides a system for producing an acoustic energy waveform, the system comprising: at least one applicator, comprising a projectile mobilizing and/or accelerating portion and at least one generating portion; the acoustic energy waveforms are generated by a collision between a mobilized and/or an accelerated projectile disposed within the accelerating portion conduit against a generating surface disposed in the generating portion; an accelerating portion is used to energize and accelerate the projectile in a controllable and directed manner toward the generating portion.

In embodiments the accelerating portion is configured to receive a pressurized fluid and/or gas source utilized to accelerate the projectile within the accelerating portion. In embodiments the volume of pressurized fluid and/or gas utilized to accelerate the projectile, herein referred to as the “accelerating fluid volume”, is controllable and/or configurable. In embodiments, the accelerating fluid volume is configured to be proportional to the volume of the accelerator portion module.

In embodiments, the volume ratio (VR) between the accelerating volume of gas and the volume of the accelerator portion may be configured to be at least about 25:1 and up to about 100:1.

In embodiments, the projectile ratio (PLDr) may be configured to have a length to diameter ratio of up to 5 : 1 and at least 1.5:1.

In embodiments, the mass ratio (MGPr) of the generating surface mass to the mass of the projectile may be configured to be from about 10:1 and up to about 45: 1.

In embodiments, the length ratio (LPAr) of the accelerating portion length relative to the projectile length may be configured to be about at least 4: 1 and up to about 15:1.

In embodiments, the ratio of the radial curvature (PSCr) of the propagating surface radius relative to the accelerating portion radius may be configured to be from about 7 : 1 and up to about 30:1.

In embodiments the pressurized fluid source may be selected from the group consisting of internal gas cylinder, external gas cylinder, gas pressure pump, gas pressure reservoir, compressor, pneumatic pump, and any combination thereof.

In embodiments the fluid providing the high-pressure fluid source may for example include but is not limited to nitrogen, air or Carbon dioxide (C02).

In embodiments the device and/or system according to the present invention may further comprise an electronics module comprising a communication module to communicate with at least one or more auxiliary device.

In embodiments, an auxiliary device may for example include but is not limited to at least one or more members selected from the group comprising an imaging device, ultrasound, X-ray, MRI, functional MRI (fMRI), computer tomography (CT), computer, server, smartphone, mobile telephone, portable device comprising processing and communication capabilities, healthcare provider computerized system, medical device console, automated livestock milking system, milking system, milking diagnostic systems, milking robot, the like or any combination thereof.

In some embodiments the system may further comprise a projectile reload module. In some embodiments, the energy density of the acoustic energy waveform according to the present invention may be configurable according to at least one or more parameter selected from: projectile mass, generating surface mass, projectile length, projectile diameter, projectile head curvature (proximal end), accelerator length, accelerator radius, accelerator gas volume, ratio of projectile length to accelerator length, ratio of projectile length to projectile radius, shockwave generating surface mass, shockwave generating surface distal end curvature, shockwave generating surface proximal end surface curvature, ratio of shockwave generating surface mass to projectile mass; ratio of shockwave generating surface density to projectile density, ratio of accelerating gas volume to accelerator portion volume, the like or any combination thereof.

Within the context of this application the term "about" when referring to a numerical parameter is intended to mean within a range of +/- 10% of the referenced numerical parameter.

Within the context of this application the term “gas” and/or "flowing fluid" and/or "fluid pressure" is intended to mean air or carbon-dioxide (C02), nitrogen or other gases and/or flowing fluids that may be compressed under pressure.

Within the context of this application the term "internal gas cylinder" is intended to mean a cylinder with small capacity of gas, integrated with applicator, wherein the cylinder may be integrated or otherwise associated with the applicator according to premedical device of the present invention.

Within the context of this application the term "external gas cylinder” is intended to mean an energy source, and/or a cylinder with large capacity of gas within the cylinder wherein the cylinder may be connected and/or otherwise associated with the medical device of the present invention by high gas pressure tubes.

Within the context of this application the term "air pressure pump” or “pneumatic piston” is intended to mean energy(air) filling source, electro-hydraulic , electro-magnetic or other pressure pump for pressure supporting.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting. Implementation of the method and system of the present invention involves performing or completing certain selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

In the drawings:

FIG. l is a schematic block diagrams of system, according to embodiment of the present invention;

FIG. 2 is schematic illustrative diagram of a modular shockwave generating device according to embodiments of the present invention;

FIG. 3A-C shows schematic illustration of shockwave generating devices, the generated shockwave and targeted treatment area; FIG. 3 A shows a PRIOR ART extracorporeal shockwave generating device; FIG. 3B shows a PRIOR ART radial shockwave generating device; FIG. 3C shows a shockwave device according to embodiments of the present invention configured to produce a burst of shockwave signals according to embodiments of the present invention;

FIG. 4A-C shows schematic illustration of shockwave waveform and/or signal generated with the corresponding devices depicted in FIG. 3A-C; FIG. 4A shows a PRIOR ART extracorporeal shockwave waveform and/or signal produced with the device depicted in FIG. 3 A; FIG. 4B shows a PRIOR ART radial shockwave waveform and/or signal produced with the device depicted in FIG. 3B; FIG. 4C shows a burst of shockwave signal according to embodiments of the present invention generated with the shockwave device depicted in FIG. 3C, according to embodiments of the present invention; and

FIG. 4D shows a real time graphical depiction of the acoustic energy waveform having a plurality of shockwave burst according to embodiments of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The principles and operation of the present invention may be better understood with reference to the drawings and the accompanying description. The following figure reference labels are used throughout the description to refer to similarly functioning components are used throughout the specification hereinbelow: 60 Auxiliary device;

100 acoustic energy generating System;

105 acoustic energy waveforms;

105a, b,c individual shockwave bursts;

105i triggering event

110 Pressurized fluid source/ Accelerating Module;

111 Pressurized fluid accelerating volume;

112 External pressure source;

114 Reservoir pressure source;

115 acceleration module (flow) control module;

130 applicator;

132 housing;

150 generating module;

151 housing;

152 projectile; 152a projectile accelerating body diameter;

152b distal end curvature radius;

152d projectile distal end radius;

152L projectile length;

152p projectile proximal end;

154 accelerator;

154L accelerator portion length;

155 reload module;

156 generating surface (anvil);

156p propagating surface curvature radius;

156d accelerating portion curvature radius

157 accelerator portion volume;

160 electronics module;

162 power supply;

164 processor controller;

166 display;

168 communication module.

Referring now to the drawings, FIG. 1 shows a schematic illustrative block diagram of an exemplary system according to embodiments of the present invention for a ballistic acoustic energy waveform generating system 100. In embodiments system 100 may be utilized for generating and applying a burst of acoustic energy waveforms 105, shown FIG. 2 and FIG. 4C-4D. In some embodiments acoustic energy waveform 105 may be applied to a human or animal body, but is not limited in uses thereto and may be used for industrial or other non-medical uses.

System 100 generates acoustic energy waveforms 105 (FIG. 2, FIG. 4C-D) as a result of a ballistic collision between a projectile 152 and a generating surface 156. Projectile 152 is accelerated and/or propelled within an accelerator 154 toward generating surface 156 where most preferably projectile 152 collides with generating surface 156 producing a burst of acoustic energy waveforms 105. Most preferably properties of the ballistic collision are configured so as to generate a burst of acoustic energy waveform 105. Projectile 152 is energized and/or accelerated and/or propelled by a pressurized fluid source and/or accelerating module 110 wherein projectile 152 is accelerated within accelerator 154 to obtain a velocity sufficient to generate a burst of acoustic energy waveforms 105, FIG. 4C-D. In embodiments the accelerating process may be controlled and/or configured according to optional parameters in order to generate the burst of acoustic energy waveforms 105.

Preferably the generated acoustic energy waveform is in the form of a burst of acoustic energy waveform 105 that is a unique shockwave waveform that comprises at least two or more sequential shockwave bursts 105a,b,c (FIG. 4D) born from a single shockwave generating event 105i (FIG. 4D), most preferably a ballistic collision between projectile 152 and generating surface 156. In embodiments, the amount of energy made available and/or the energy density of the burst of acoustic energy waveforms 105 and/or the number of shockwave bursts in the acoustic energy waveforms may preferably be controlled by controlling at least one or more parameters system 100.

In embodiments the at least one or more system parameters provided for controlling the generation of the acoustic energy waveform 105 having at least two or more individual shockwave bursts 105a,b,c (FIG. 4C-D) may for example include but is not limited to at least one or more of: a) PLDr parameter - defined as the ratio of projectile length (152L) to projectile diameter (152a), wherein the ratio may be selected so as to have a length to diameter ratio of up to 5 (5:1) and at least 1.5 (1.5:1); b) MGPr parameter - defined as the mass ratio between the mass of the generating surface (156) and the mass of the projectile (152) that is configured to be from about 10 (10: 1) and up to about 45 (45: 1); c) LPAr parameter - defined as the length ratio, between the length of the accelerating portion length (154) relative to the projectile length (152L), that is configured to be about at least 4 (4:1) and up to about 15 (15:1). d) PSCr parameter - defined as the ratio of the radial curvature of the propagating surface (156p) relative to the radial curvature of accelerating portion (156d) that is configured to be from about 7 (7: 1) and up to about 30 (30: 1); e) VR - defined as the volume ratio between the volume of the accelerator portion (154,157) and the pressurized fluid volume (111) utilized, defined as the volume of pressurized fluid (111) utilized to accelerate the projectile (152) within the accelerator portion (154,157), the ratio configured to be from about 25 (25:1) and up to about 100 (100:1);

In embodiments, mobilizing module 110 provide for accelerating and/or mobilizing projectile 152 toward generating surface 156. Preferably mobilizing module 110 is provided in the form of a pressurized fluid source that is controllably released via a flow controller module 115 so as to release a configurable and/or controllable volume of pressurized fluid 111 interchangeably referred to as pressurized fluid accelerating volume. In embodiments, pressurized fluid accelerating volume 111 preferably provides the fluid pressure source necessary to accelerate and/or power and/or energize projectile 152 within accelerator 154 so as to generate the burst of energy waveforms 105.

In embodiments, the pressurized fluid source and/or mobilizing module 110 may comprise optional forms and/or sources of pressurized fluids and/or gasses for example including but not limited to an external fluid pressure source 112 and/or an internal pressure source 114. For example, internal pressure source may be provided in the form of a compact internal gas cylinder. For example, an external pressure source 112 may be realized in the form of a large, pressurized gas cylinder, that is connected to the mobilizing module 110 to energize projectile 152.

In embodiments external pressure source 112 may be provided in a plurality of optional forms for example including but not limited to at least one or more of an external gas cylinder, pump, pressure reservoir, compressor, pneumatic pump, the like, or any combination thereof.

In some embodiments mobilizing module 110 may be provided as a direct pressure source and/or an indirect pressure source.

An optional embodiment of the present invention provides for utilizing a mobilizing module 110 in the form of a pressurized fluid source 110 provided as a direct pressure source that may for example be realized in the form of a portable pressurized gas cylinder and/or balloon.

An optional embodiment of the present invention provides module 110 as an indirect source of high pressurized flowing fluid. For example, an indirect pressure source may be realized by way of utilizing a combination of an external high pressure gas cylinder (external gas cylinder) that is coupled with a gas pressure reservoir (internal gas cylinder) most preferably such an indirect high-pressure source may be mediated by a flow controller 115. Flow controller 115 may for example be provided in the non-limiting form of a controlling valve and/or pressure regulator so as to provide configuration and/or controlled release of pressurized fluid from a pressurized fluid source of module 110.

In embodiments system 100, configured to utilize a pressurized fluid source 110, 114, 112, may utilize a flow control module 115, that may optional comprise at least one or more flow controlled s) to facilitate control and use of the pressurized fluid source. Optionally flow controller may be provided in a plurality of optional forms for example including but not limited to a valve, solenoid valve, pressure regulator, pneumatic piston, pneumatic valve, the like, or any combination thereof provided for controlling the flow of fluid pressure source 112 within any portion of system 100 and more preferably through accelerator 154.

In some embodiments accelerator flow control module 115 may comprise a mechanical flow control members for example including but not limited to a trigger, valve gating member, valve open and close apparatus, or the like mechanical flow control member to control the volume of pressurized fluid volume 111 released into accelerator 154.

In embodiments flow controller module 115 may for example be controlled with portions of electronics module 160 for example with controller 164 and/or optionally with communications module 168.

In embodiments system 100 may comprise a plurality of flow controllers within control module 115 provided to control high pressure fluid flow between at least two members or portions thereof, for example including but not limited to a first pressure source, an external pressure source 112 a second pressure reservoir, an internal pressure source 114, pressure source to at least one or more applicator (130), the like or any combination thereof, so as to release a controlled volume of accelerating pressurized fluid 111.

In embodiments system 100 may comprise an optional electronics module 160. Optionally and preferably electronics module 160 comprises power supply 162, controller and/or processor 164 and display 166. Optionally electronics module 160 may further comprise a communication module 168. Optionally controller and/or processor 164 may provide for controlling any portion of system 100. Optionally and most preferably controller 164 may provide for controlling the parameters associated and utilized to generate the burst of acoustic energy waveform 105 with generating module 150 and/or accelerating module 110 and/or applicator 130 and/or any portions of system 100.

In embodiments power supply 162 may be utilized to power system 100 and/or portions thereof. Power supply 162 may for example be provided in the form for example including but not limited to photo-galvanic cells, battery, rechargeable battery, disposable batteries, capacitors, super capacitors, or a mains power supply line, the like power source or any combination thereof.

In embodiments display 166 may be provided in optional forms for example including but not limited to indictors, alphanumeric display, touch screen, the like or any combination thereof.

In embodiments communication module 168 may be provided for communicating with optional auxiliary devices 60 for example utilizing wireless communication protocols, cellular communication, wired communication, near field communication, the like and/or any combination thereof. Optionally auxiliary devices 60 may be in communication with system 100 may for example include but is not limited to an imaging device, ultrasound, X-ray, MRI, functional MRI (fMRI), CT, computer, server, smartphone, mobile telephone, portable device comprising a processing and communication capabilities, healthcare provider computerized system, medical device console, automated livestock milking system, milking system, milking diagnostic systems, milking robot, other devices, the like or any combination thereof.

In embodiments applicator 130 may provide for generating a burst of acoustic energy waveforms 105 by converting energy from a ballistic collision between projectile 152 and generating surface 156 to generate a burst of acoustic energy waveforms 105 so as to propagate and/or deliver waveforms 105 toward a target tissue with propagating surface 156p.

In embodiments an acoustic energy waveform generating module 150 may further comprise a projectile reloading apparatus 155 that facilitates the formation of subsequent and/or successive acoustic energy waveforms 105.

In embodiments, system 100 preferably provides for generating an acoustic energy waveforms 105 to deliver acoustic energy across a tissue depth of more than 5cm from skin surface. Most preferably the characteristics of the acoustic energy waveform 105 are provided by controlling and/or selecting at least one or more parameter selected from: a) PLDr parameter - defined as the ratio of projectile length (152L) to projectile diameter (152a), wherein the ratio may be selected so as to have a length to diameter ratio of up to 5 (5:1) and at least 1.5 (1.5:1); b) MGPr parameter - defined as the mass ratio between the mass of the generating surface (156) and the mass of the projectile (152) that is configured to be from about 10 (10:1) and up to about 45 (45:1); c) LPAr parameter - defined as the length ratio, between the length of the accelerating portion length (154) relative to the projectile length (152L), that is configured to be about at least 4 (4:1) and up to about 15 (15:1). d) PSCr parameter - defined as the ratio of the radial curvature of the propagating surface (156p) relative to the radial curvature of accelerating portion (156d) that is configured to be from about 7 (7: 1) and up to about 30 (30: 1); e) VR - defined as the volume ratio between the volume of the accelerator portion (154,157) and the pressurized fluid volume (111) utilized, defined as the volume of pressurized fluid (111) utilized to accelerate the projectile (152) within the accelerator portion (154,157), the ratio configured to be from about 25 (25:1) and up to about 100 (100:1);

In some embodiments, the characteristics of the acoustic energy waveform 105 are provided by controlling and/or selecting at least two or more parameter selected from: PLDr parameter, MGPr parameter, LPAr parameter, PSCr parameter, VR, or any combination thereof.

In some embodiments, the characteristics of the acoustic energy waveform 105 are provided by controlling and/or selecting at least three or more parameter selected from: PLDr parameter, MGPr parameter, LPAr parameter, PSCr parameter, VR, or any combination thereof.

In some embodiments, the characteristics of the acoustic energy waveform 105 are provided by controlling and/or selecting the following parameter: PLDr parameter, MGPr parameter, LPAr parameter, PSCr parameter, and VR, in any combination thereof. FIG. 2 show a schematic illustration acoustic energy generating system 100 according to embodiments of the present inventions wherein a burst of acoustic energy waveform 105 is generated with a generating module and/or device 150 by utilizing a pressurized fluid and/or gas source 110.

As described above device 150 is configured to utilize a ballistic collision between a projectile 152 and shockwave generating surface 156 (anvil) to generate a new shockwave energy waveform that is characterized by the presences of multiple shockwaves (burst) from a single ballistic event and/or collision. The burst of acoustic energy waveform 105, FIG. 4C-D, features at least two shockwaves (burst) generated over a timeframe of about 250 microseconds.

As previously described device 150 is configured to produce a burst of shockwave energy waveform 105 from a single ballistic event between a projectile and a generating surface 156.

As described above a ballistic collision and/or event is generated by accelerating projectile 152 within accelerator 154 having an acceleration volume 157. Preferably, projectile 152 is mobilized by a configurable pressurized fluid accelerating volume 111 that is introduced into volume 157. Pressurized fluid accelerating volume 111 is introduced via flow control module 115, provided to control the release of pressurized fluid from an accelerating module 110 preferably provided in the form of a pressurized fluid source. Accordingly, pressurized fluid that is introduced into volume 157 mobilizes projectile 152 within accelerating portion 154 toward shockwave generating surface 156.

In embodiments shockwave generating surface 156 comprises two surfaces that facilitate formation of shockwave energy waveform 105, a first surface 156d for generating the ballistic event and a second surface 156p for propagating waveform 105. Both generating surface 156d and propagating surface 156p are provided with a configurable curvature radius.

In embodiments of system 100 and device 150 may be configured to produce a burst of waveforms 105 by controlling the ballistic collision environment with at least one or more of the following parameters: a) PLDr parameter - defined as the ratio of projectile length (152L) to projectile diameter (152a), wherein the ratio may be selected so as to have a length to diameter ratio of up to 5 (5:1) and at least 1.5 (1.5:1); b) MGPr parameter - defined as the mass ratio between the mass of the generating surface (156) and the mass of the projectile (152) that is configured to be from about 10 (10:1) and up to about 45 (45:1); c) LPAr parameter - defined as the length ratio, between the length of the accelerating portion length (154) relative to the projectile length (152L), that is configured to be about at least 4 (4:1) and up to about 15 (15:1). d) PSCr parameter - defined as the ratio of the radial curvature of the propagating surface (156p) relative to the radial curvature of accelerating portion (156d) that is configured to be from about 7 (7: 1) and up to about 30 (30: 1); e) VR - defined as the volume ratio between the volume of the accelerator portion (154,157) and the pressurized fluid volume (111) utilized, defined as the volume of pressurized fluid (111) utilized to accelerate the projectile (152) within the accelerator portion (154,157), the ratio configured to be from about 25 (25:1) and up to about 100 (100:1).

Now referring to FIG. 3 A-C and FIG. 4A-C, as would be appreciated by those skilled in the art, the figure shows a comparative view of state-of-the-art shockwave generating systems, FIG. 3 A-B and FIG. 4A-B, while FIG. 3C and FIG. 4C show the shockwave generating system 100 and a burst of shockwave 105 according to embodiments of the present invention.

FIG. 3 A shows a schematic illustration of state of the art extracorporeal shockwave generating system lOe that produces an extracorporeal shockwave that are adept at treating a single treatment site at a defined focal zone. The shockwave (SW) is generated by spark gap technology and is reflected toward the treatment site that is at an increased tissue depth , as shown with the arrow. As can be seen the extracorporeal shockwave device is capable of producing a single shockwave (SW) from a single SW generating event. The produced shockwave can reach deep lying tissue, however, it is limited in doing by a single SW at the specific focal zone, treatment site. FIG. 4A shows the shockwave (SW) waveform that is produced with the system depicted in FIG. 3 A. The SW is characterized in that it has a very short lifespan of under 5 microseconds and produces a single high pressure peak at the onset of the waveform.

FIG. 3B shows a schematic of state of the art radial-wave shockwave generating system lOr. Such a radial wave shockwave system produces a single SW at limited tissue depth, as radial wave cannot penetrate deep into tissue, however, the radial wave is able to cover a broad tissue treatment site, as shown, so long as it is near the shockwave generating surface. As can be seen the radial shockwave system lOr is capable of producing a single shockwave (SW) from a single SW generating event. FIG. 4B shows the shockwave (SW) waveform that is produced with the system depicted in FIG. 3B. The SW is characterized in that it has a long lifespan of about 1000 microseconds and having a low pressure peak that is spread over the signal’s extended lifespan.

Therefore, each of the state of the art systems, FIG. 3 A, 4A and FIG. 3B, 4B are limited in at least one of SW tissue penetration depth and size or the peak pressure available at the targeted tissue site.

The device 150 and system 100 according to embodiments of the present invention, FIG. 3C and FIG. 4C, overcome these deficiencies of the state of the art SW devices. FIG. 3C shows a schematic illustration of previously described system 100 and shows that a single ballistic event, between projectile 152 and anvil 156, generates a unique shockwave waveform 105 that is capable both of to treat tissue at increased depth and size, therein a large treatment site may be produced, and furthermore produces, at least two or more and more preferably multiple shockwave bursts, that individually feature high pressure peaks and a total lifespan of up to about 250 microseconds. Accordingly, the shockwave waveforms 105 according to embodiments of the present invention, shown schematically in FIG. 4C, is therefore adapted to treat a large tissue area at extended tissue depths from the surface of the skin. The shockwave waveform 105 is characterized in that a single shockwave generating events produces a plurality of shockwaves, that display sufficient energy in each burst to treat tissue at increased depths and areas. FIG. 4D shows an example of acoustic energy waveform 105 as achieved with the system 100 according to embodiments of the present invention. Waveform 105 comprises a plurality of shockwave burst 105a, 105b, 105c that are generated with a single triggering event 105i.

The present inventions are neither limited to any single aspect nor embodiment thereof, nor to any combinations and/or permutations of such aspects and/or embodiments. Moreover, each of the aspects of the present inventions, and/or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the present inventions and/or embodiments thereof. For the sake of brevity, many of those permutations and combinations will not be discussed separately herein. Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not described to limit the invention to the exact construction and operation shown and described and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Having described a specific preferred embodiment of the invention with reference to the accompanying drawings, it will be appreciated that the present invention is not limited to that precise embodiment and that various changes and modifications can be effected therein by one of ordinary skill in the art without departing from the scope or spirit of the invention defined by the appended claims.

While the invention has been described with respect to a limited number of embodiment, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.

Claims

What is claimed is:

1) A system (100) for producing an acoustic energy waveforms (105) produced by way of a ballistic collision, the system comprising: a) a pressurized fluid and/or gas source (110) and applicator (130), the applicator including a generating module (150) having a projectile (152) that is accelerated within an accelerator portion (154) toward a generating surface (156); the generating surface having a propagating surface wherein said acoustic energy waveforms (105) are propagated; and wherein generating said acoustic energy waveforms (105) are provided by controlling at least one parameter selected from: i) ratio of projectile length to projectile diameter (PLDr); ii) ratio of a mass of said projectile relative to a mass of said generating module (MGPr); iii) ratio of length of accelerator relative to length of said projectile (LPAr); iv) ratio of radial curvature of said propagating surface relative to said accelerating portion (PSCr); v) ratio of volume of said accelerating module to the volume of said accelerating gas (VR); b) the accelerating module (110) utilized to energize and accelerate said projectile in a controllable and directed manner within said accelerator portion (154) to generate said acoustic energy waveform (105); and c) an electronics module (160) for controlling the system.

2) The system of claim 1 wherein said generated acoustic energy waveform (105) is characterized in that it comprises at least two shockwave bursts (105a, 105b, 105c) each having a pressure peak.

3) The system of claim 1 wherein the energy density of said acoustic energy waveform (105) is configurable according to at least one parameter selected from: projectile mass, generating surface mass, projectile length, projectile diameter, projectile head curvature (proximal end), accelerator length, accelerator radius, accelerator gas volume, ratio of projectile length to accelerator length, ratio of projectile length to projectile radius, shockwave generating surface mass, shockwave generating surface distal end curvature, shockwave generating surface proximal end surface curvature, ratio of shockwave generating surface mass to projectile mass; ratio of shockwave generating surface density to projectile density, ratio of accelerating gas volume to accelerator portion volume.

4) The system of claim 1 wherein the ratio of projectile length to projectile diameter is from 1.5:1 and up to 5:1.

5) The system of claim 1 wherein the mass ratio of mass of generating module to mass of projectile is from 10:1 to 45:1.

6) The system of claim 1 wherein the ratio of accelerating portion length to the projectile length is from 4:1 to 15:1

7) The system of claim 1 wherein the ratio of the propagating surface curvature radius (156p) to the radius of accelerating portion radius (156d) is from 7 : 1 and up to 30: 1.

8) The system of claim 1 wherein the ratio of the accelerating gas volume (111) to the accelerator portion volume (157) is from 25:1 to 100:1

9) The system of claim 1 wherein the electronic module (160) comprising a communication module (166) in communication with at least one or more auxiliary device (60) selected from the group consisting of imaging device, ultrasound, X-ray, MRI, functional MRI (fMRI), CT, computer, server, smartphone, mobile telephone, portable device comprising processing and communication capabilities, healthcare provider computerized system, medical device console, automated livestock milking system, milking diagnostic systems, milking system, any combination thereof.