Systems, devices, and methods for treating tissues and cellulite through non-invasive ultrasound subcutaneous cutting.

Abstract

The embodiments of this invention refer to systems, apparatuses, and methods for inducing physical effects in tissues such as dermis, fat, musculoskeletal system, blood vessels, and liver tissue using unfocused or planar, non-cavitary acoustic shock waves. These physical effects include the disruption of the fibrous extracellular matrix of the target tissue. The embodiments of this invention involve applying a plurality of rapid acoustic pulses (e.g., shock waves) to cause the disintegration of the fibrous extracellular matrix, thereby reducing cellulite or scarring in the treated area. Such unfocused or planar, non-cavitary acoustic shock waves can induce tissue responses such as reduced fibrosis, angiogenesis, or lymphangiogenesis.

Description

[0001] [Cross-reference related applications]

[0002] This application claims the rights of U.S. Provisional Patent Application No. 62 / 829,026, filed April 3, 2019, and U.S. Provisional Patent Application No. 62 / 892,973, filed August 28, 2019, which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention generally relates to an apparatus and method for treating tissues and cellulite using shock waves. More specifically, but not limitingly, this invention relates to a method for treating target tissues by using shock waves to disrupt the extracellular matrix of the target tissue fibers. Background Technology

[0004] Gynoid lipodystrophy is a localized disorder of the subcutaneous tissue that causes changes in the topography of the skin, such as a pitted appearance instead of a smooth one. This symptom, commonly known as "orange peel," typically appears on the hips, buttocks, and thighs.

[0005] Cellulite forms in the subcutaneous tissue, more specifically in the subcutaneous fat layer beneath the epidermis and dermis. In this region, fat cells are housed in compartments surrounded by bands of fibrous connective tissue called septa (also known as trabeculae and containing collagen bundles). Cellulite can be attributed to the generally horizontal orientation of these fibrous structures (like pillars), which are slightly orthogonal to the skin. The fat cells are confined within the periphery defined by these fibrous structures and expand with weight gain and aging, thus stretching the septa and surrounding connective tissue. Eventually, this connective tissue contracts and hardens (becoming sclerotic), confining the skin to a non-flexible length, while the compartments between the septa continue to expand, for example, with weight gain or edema. This causes the skin to sag, while adjacent areas bulge outwards, resulting in the unsightly roughness, "orange peel," or "caramelized" appearance.

[0006] Subcutaneous incision is a surgical procedure used to treat depressed skin scars, wrinkles, and cellulite creases and ridges. It is also known as subcutaneous excision surgery. A subcutaneous incision involves inserting a special hypodermic needle (e.g., a tri-beveled hypodermic needle) through a puncture in the skin's surface. The sharp edge of the needle is manipulated below the defect to perform a subcutaneous cut or "cut," breaking the fibrous tissue bundles that tether a skin defect (such as a scar, wrinkle, or cellulite crease) to the underlying tissue. The principle of this procedure is to break these fibrous tissue bundles that bind the scar to the underlying subcutaneous tissue. The defect or depression is lifted by the release action of the procedure, as well as from the new connective tissue that forms during the normal wound healing process. Another option for performing subcutaneous incision with a hypodermic needle is to use a laser (e.g., laser-assisted subcutaneous incision). A laser can be inserted into a perforation in the skin surface to have a line of sight to the fibrous tissue generating bundle, so that the laser can apply energy to "cut" the fibrous tissue generating bundle by radiation, which is attached to a skin defect.

[0007] As an example, subcutaneous incision using a triangular-angled subcutaneous injection needle is performed under local anesthesia, such as topical or infiltration anesthesia. An 18 or 20 gauge needle, or a Nokor needle (1.5 inches, 18 gauge), is inserted into the dermal depression at an upward angle, parallel to the skin surface, and into the deep dermis. The needle is moved back and forth in a fan-like motion beneath the scar or defect to release fibrous bands at the dermal or deep dermal subcutaneous plane. The needle is removed, and the wound is circumferentially compressed around the exit point to drain excess blood and prevent large hematoma formation. A small hematoma is allowed to form, supporting the released scar. Pressure and ice are applied to maintain hemostasis.

[0008] Cutting or removing the fibrous septum in the subcutaneous area using current subcutaneous incision methods is laborious, time-consuming, and highly unpredictable. Bruising and mild pain are common a few days after the procedure and will subside over time without intervention.

[0009] Besides subcutaneous incision, various other solutions for treating cellulite and removing excess adipose tissue have been proposed. For example, mechanical massage techniques on the affected area have been explored and proposed, aiming to break down lumpy tissue and / or increase lymphatic drainage to smooth the skin surface. In another example, the application of various topical agents has been proposed, aiming to break down lumpy tissue and / or increase collagen production. Methods and devices for using ultrasound to break down subcutaneous tissue have also been described. These methods and devices break down other subcutaneous tissues (e.g., tissues and structures other than fibrous septa) by creating biological effects and reactions, aiming to induce a healing response to promote collagen growth.

[0010] However, these other approaches rely on different mechanisms than subcutaneous incisions to treat cellulite. Specifically, these other approaches do not attempt, and have not yet demonstrated, the ability to break the fibrous tissue bundles that tether a skin defect (such as a scar, wrinkle, or cellulite depression) to the underlying tissue, as is done in subcutaneous incisions. While subcutaneous incisions offer longer, more lasting results and the ability to treat higher grades of cellulite (such as grade 2 and above), they also have all the disadvantages associated with any surgical procedure, such as pain, sensory loss, healing time, complications, and the risk of infection. For example, complications include large hematomas due to bleeding (small hematomas are normal), tenderness at the treated site, hypertrophic scarring (5 to 10%) or keloid scarring, infection, temporary post-inflammatory hyperpigmentation (requiring sun protection / avoidance), suboptimal response or lack of improvement, and damage to nerves or blood vessels. The healing process can take several weeks, and pain, bruising, and / or hematoma formation near the treatment site are common.

[0011] Furthermore, subcutaneous incision is unsuitable for certain patient groups, such as those with a history of hypertrophic or keloid scarring, current or recent (e.g., within 12 months) systemic oral retinoids (e.g., acitretin, isotretinoin), bleeding or blood clotting disorders (e.g., coagulopathy), or active bacterial or viral infections. Therefore, current non-invasive techniques cannot perform subcutaneous incision and are ineffective in reducing the appearance of high cellulite, scarring, and fibrosis. Additionally, current invasive techniques are unsuitable for certain patient groups and involve significant complications, pain, and recovery time.

[0012] Furthermore, over the past four decades, extracorporeal shock wave therapy (ESWT) has been used in clinical medicine for a wide range of indications. The effects of ESWT on tissues are considered primarily mechanical due to cavitation bubbles. The powerful force applied to an area of ​​a collapsing cavitation bubble causes mechanical fragmentation or microlesions within the tissue. This tissue fragmentation leads to a tissue response (such as healing), such as the formation of new blood vessels.

[0013] Cavitation bubbles form and grow during the negative pressure pulse at the tail of a shock wave. When a cavitation bubble collapses, it generates a flow field that induces shear stress on nearby sticky cells. This shear stress is strong enough to break the adhesion between the cell and the substrate, destroy the cell, or temporarily make the cell membrane permeable, thus facilitating molecular uptake.

[0014] However, cavitation bubbles can cause pain. Extracorporeal shock wave therapy and other focused shock wave therapies produce shock wave-induced pain, which is often described as stinging and intense. Shock waves in bodily fluids or tissues generate cavitation bubbles that form, move, and implode, causing pain by stimulating superficial injury receptors in the skin and deeper visceral injury receptors in the kidneys, pleura, peritoneum, and muscles. Therefore, current shock wave therapy does not promote tissue response and does not provide a treatment that is painless and does not rely on cavitation. Summary of the Invention

[0015] Specific embodiments of this invention refer to systems, apparatus, and methods for using high-frequency shock waves to break up the fibrous extracellular matrix of target tissue. In some embodiments, high-frequency shock waves are applied to the skin to sever hardened (e.g., rigid and unresponsive) fibrous septa in subcutaneous fat. Breaking and / or severing of the fibrous septa in subcutaneous fat can lead to an improvement in the appearance of cellulite (e.g., smoother skin). Breaking and / or severing of the fibrous septa in subcutaneous fat is a physical effect not produced by conventional sonic therapy. The high-frequency shock waves described herein also produce or cause biological effects similar to those of conventional sonic therapy, such as collagen regeneration, angiogenesis, lymphangiogenesis, and inflammation suppression. In some embodiments, the applied shock waves are applied at a frequency and magnitude such that the shock waves are applied to dermal ridges, depressions, or defects. In some embodiments, the medical and cosmetic approach to treatment can reduce unwanted side effects and total times per treatment (TTPT) compared to known systems. Furthermore, this shockwave therapy can be used non-invasively, which can significantly reduce complications, shorten the time between treatments, and increase patient comfort.

[0016] Some specific embodiments of this invention refer to systems, apparatus, and methods for inducing tissue responses by mechanically disrupting the fibrous extracellular matrix of tissue structures using unfocused, non-cavitating, rapid acoustic pulses (RAP) (e.g., acoustic shockwave pulses). Such embodiments of this invention involve applying a plurality of rapid acoustic pulses to cause disruption within the tissue structure, resulting in a painless tissue response. In one particular embodiment, the tissue response is a reduction in fibrous tissue formation. In another particular embodiment, the tissue response is the induction of angiogenesis, collagenogenesis, and / or lymphangiogenesis. Such tissue responses are effective in treating trauma, scars (i.e., scar-like, hypertrophic, etc.), implant cyst contraction, fibrogenic patches (e.g., Peyronie's disease), and fibrogenic organs (e.g., liver fibrosis).

[0017] There are two fundamental effects of acoustic shock waves. The first is characterized by the direct generation of mechanical force (e.g., the primary effect of positive compression and high pressure), and the second is the indirect generation of mechanical force through cavitation (e.g., high-velocity pressure micro-jet). Cavitation is a secondary effect arising from the negative tensile pressure region of the shock wave. Furthermore, the positive and negative portions / regions of the shock wave operate in tandem, and have a synergistic effect of enhancing the acoustic pressure shock wave effect.

[0018] In focused acoustic wave (SAW) oscillation plays a major role in disrupting the outer membrane of pathogens present in various tissue states or stimulating tissue regeneration. In SAW oscillation, "in order for the cavitation phase of a focused acoustic pressure wave, or radial acoustic pressure wave, or planar acoustic pressure wave, or cylindrical acoustic pressure wave to have its maximum potential, the repetition rate or frequency is preferably in the range of 1 to 8 Hz." (US Patent No. US20180221688A1). Furthermore, the cavitation bubbles need sufficient time to grow to their maximum size and then collapse at a high speed exceeding 100 m / s. Frequencies above 8 Hz are generally not preferred for tissue processing. See US Patent No. US20180221688A1.

[0019] As disclosed in U.S. Patent No. 6,390,995, the micro-disruptions inherent in focused shockwave therapy are thought to induce cellular changes, as well as changes in the extracellular matrix and macromolecules, in a controlled manner to stimulate increased angiogenesis, leading to appropriate tissue angiogenesis. Increased circulation and angiogenesis then induce the body's natural (tissue-specific) cellular healing processes. A significant tissue effect arises from the cavitation caused by the negative phase of wave propagation.

[0020] However, one problem with focused shockwave therapy is that cavitation bubbles can cause pain. Shockwave-induced pain is typically described as stinging and intense. The formation, movement, and bursting of cavitation bubbles generated by shockwaves in bodily fluids or tissues irritate superficial damage receptors in the skin and deeper visceral damage receptors in the kidneys, pleura, peritoneum, and muscles, resulting in pain and discomfort for the treated patient.

[0021] Given the problems caused by cavitation-induced pain, many of the beneficial effects of conventional (e.g., focused) shock waves can be achieved through the use of unfocused and / or planar shock waves, providing a tissue response through "microbiological effects" rather than mechanical effects. Specifically, unfocused and / or planar shock waves can be used to stimulate a cellular response without establishing cavitation bubbles that would cause cell or tissue damage and pain management. The stimulated cells and tissues will then release or produce one or more growth factors that accelerate healing. Avoiding the mechanical effects of cavitation bubbles effectively ensures that patients do not experience the pain commonly found in focused shock wave formats.

[0022] Some specific embodiments of this device (e.g., an acoustic subcutaneous cutting device configured to use a plurality of rapid acoustic pulses to cause rupture of fibrous structures (dermis and / or subcutaneous tissue)) include: a housing, a pulse generating system, and a controller. The pulse generating system is connected to the housing. The controller is connected to the pulse generating system and configured to cause the pulse generating system to generate a plurality of shock wave pulses. The shock wave pulses are configured to cause rupture of the fibrofatty diaphragm.

[0023] In some of the aforementioned embodiments of this device, the housing defines a chamber and a shock wave outlet, the chamber being configured to receive liquid, and the device further includes: a plurality of electrodes, an acoustic wave reflector, and a single servo motor. The plurality of electrodes are arranged in the chamber to define one or more spark gaps. The acoustic wave reflector is arranged in the chamber. The single servo motor is mechanically connected to the plurality of electrodes. Each spark gap has a spark gap size and a spark gap location, and the single servo motor is configured to adjust each of the plurality of electrodes to maintain a consistent spark gap size and spark gap location.

[0024] In some of the foregoing embodiments of this device, the acoustic reflector includes a free-form acoustic reflector. In some implementations, a plurality of electrodes include a first electrode and a second electrode, and a single servo motor is mechanically connected to the first electrode and the second electrode.

[0025] In some of the foregoing embodiments of this device, the device further includes a plurality of pivot arms mechanically connected to a second electrode. In some implementations, the plurality of pivot arms are arranged to advance the second electrode toward the first electrode in response to the actuation of a single servo motor.

[0026] In some of the foregoing embodiments of this device, the device further includes a controller configured to send signals to a single servo motor via a closed-loop control to actuate it, thereby moving a plurality of electrodes and maintaining a consistent spark gap. In some implementations, the controller is further configured to send signals to a single servo motor via a closed-loop control, wherein, in sending signals to the single servo motor, the controller is configured to: measure a pulse duration of discharge of the plurality of electrodes at an identified charging voltage; and, based on the measured pulse duration, send signals to the single servo motor to move it, thereby maintaining a consistent spark gap.

[0027] In some of the foregoing embodiments of this device, the pulse generation system is configured to connect to a plurality of electrodes, such that the housing is movable relative to the pulse generation system, and the pulse generation system is electrically connected to the plurality of electrodes. In some implementations, the acoustic reflector is a single unit separate from the housing. In some of the foregoing embodiments of this device, the pulse generation system includes a plurality of electrohydraulic (EH) spark heads.

[0028] In some of the aforementioned embodiments of this device, each high-frequency wavefront of the shock pulse has a rise time of less than 500 nanoseconds. In some implementations, each high-frequency wavefront of the shock pulse has a rise time of less than 100 nanoseconds. Alternatively, the shock pulse has a peak output pressure of 1 to 20 megapascals, 6 to 20 megapascals, 1 to 30 megapascals, or 6 to 30 megapascals.

[0029] In some of the aforementioned embodiments of this device, the acoustic subcutaneous cutting device is configured to output shock wave pulses at a pulse repetition frequency greater than 10 Hz. In some implementations, the acoustic subcutaneous cutting device is configured to output shock wave pulses at a pulse repetition frequency greater than 20 Hz.

[0030] Some specific embodiments of this system (e.g., an acoustic hypodermal cutting system configured to use a plurality of rapid acoustic pulses to cause fibrous structure fragmentation) include: a shock wave generating probe and a vacuum head. The shock wave generating probe includes: a housing, a pulse generating system, a free-form reflector head, and a controller. The pulse generating system is connected to the housing. The free-form reflector head is connected to the housing. The controller is connected to the pulse generating system and configured to cause the pulse generating system to generate a plurality of shock wave pulses. The shock wave pulses are configured to cause fibrofatty diaphragmatic fragmentation. The vacuum head is configured to generate negative pressure at a treatment site.

[0031] In some of the foregoing embodiments of this system, the system further includes a vacuum system. The vacuum system includes a control unit and a conduit. The control unit includes a valve, a motor, an indicator, and a controller. The motor is connected to the valve and configured to adjust the valve. The indicator is configured to output an indication corresponding to the position of the valve. The controller is configured to transmit a plurality of control signals to the motor and the indicator. The conduit is configured to connect to the control unit and to a vacuum head. The vacuum head includes a vacuum head housing, a compliant member, one or more sensors, and one or more lamps. The vacuum head housing defines a window and one or more ports. The compliant member is connected to the vacuum head housing. One or more sensors are connected to the housing. One or more lamps are connected to the vacuum head housing. In some of the foregoing embodiments of this system, the controller is integrated with the vacuum head, and the fiber structure includes a dermal fiber structure, a subcutaneous fiber structure, or both.

[0032] Some specific embodiments of the present invention, which use a sonic subcutaneous cutting device to treat a patient to improve the appearance of cellulite, include: positioning the sonic subcutaneous cutting device adjacent to a treatment site; and applying a shock wave to the treatment site, wherein the shock wave is positioned to cause rupture of the fibrofatty septum. In some of the foregoing specific embodiments of the method, the method further includes applying a plurality of shock waves to the treatment site, wherein the plurality of shock waves are applied at a pulse repetition frequency between 10 Hz and 200 Hz.

[0033] In some of the foregoing embodiments of this method, a plurality of shock waves are applied during multiple processing durations within a processing period. In some implementations, the processing site comprises multiple processing areas, and the plurality of shock waves cause the dermal fibrous structure, subcutaneous fibrous structure, or both to break down.

[0034] In some of the foregoing specific embodiments of this method, the method further includes: repositioning the acoustic subcutaneous cutting device to a second treatment area of ​​one of the treatment sites; applying a plurality of second shock waves to the second treatment area; and interrupting the treatment period of one of the treatment sites. In some implementations, the treatment site has an area of ​​100 square centimeters. In other implementations, the treatment site has an area of ​​400 square centimeters.

[0035] In some of the foregoing specific embodiments of this method, a processing period includes applying one or more treatments to one or more treatment sites, wherein a processing period is repeated daily, weekly or monthly.

[0036] In some of the foregoing specific embodiments of this method, the method further includes placing a dermal ridge within the treatment site, and wherein multiple shock waves are applied to the dermal ridge.

[0037] In some of the foregoing embodiments of this method, the method further includes: positioning a vacuum head on the processing area; applying the vacuum head to the processing area; and generating a negative pressure at the processing area. In some implementations, the method further includes applying cooling air to the processing area. Alternatively or otherwise, the method further includes removing the vacuum head from the processing area.

[0038] In some of the aforementioned embodiments of this method, the shock wave is emitted from a free-form acoustic reflector. In some implementations, the free-form acoustic reflector is not parabolic in shape or is not shaped like a parabola.

[0039] In some of the foregoing embodiments of this method, one of the high-frequency wavefronts of the shock wave has a rise time of less than 500 nanoseconds. In some implementations, one of the high-frequency wavefronts of the shock wave has a rise time of less than 250 nanoseconds. In some implementations, one of the high-frequency wavefronts of the shock wave has a rise time of less than 100 nanoseconds. In some of the foregoing embodiments of this method, the shock wave has a peak output pressure of 6 to 30 megapascals.

[0040] In some of the foregoing embodiments of this method, the shock wave has a peak output pressure of 5 million Pascals, and the acoustic subcutaneous cutting device has a pulse repetition frequency of 50 Hz. In some such implementations, the duration of treatment at one treatment site is one minute, and the treatment time period at one treatment site is twenty minutes. In some such implementations, the duration of treatment at one treatment site is two minutes, and the treatment time period at one treatment site is twenty-five to forty-five minutes. In a particular implementation, the treatment time period at one treatment site is thirty minutes.

[0041] In some of the aforementioned embodiments of this method, the shock wave has a peak output pressure of 10 megapascals, and the acoustic subcutaneous cutting device has a pulse repetition frequency of 50 Hz. In some such implementations, the treatment duration of one treatment area is two minutes, and the treatment time of one treatment area is twenty minutes.

[0042] In some of the aforementioned embodiments of this method, the shock wave has a peak output pressure of 6 million Pascals, and the acoustic subcutaneous cutting device has a pulse repetition frequency of 100 Hz. In some such implementations, the treatment duration of one treatment site is three minutes, and the treatment time of one treatment site is twenty minutes.

[0043] In some of the foregoing specific embodiments of this method, the method further includes applying 500 to 60,000 acoustic pulses to each treatment area of ​​the treatment site.

[0044] Some specific embodiments of this method, which treats a patient to improve the appearance of cellulite by using multiple rapid sonic pulses to cause fibrous structure disruption, include: identifying a treatment site containing cellulite; and applying a series of shockwave pulses to the treatment site.

[0045] In some of the foregoing embodiments of this method, the treatment area corresponding to one of the treatment sites is within a depth of 0.5 to 6 cm from the outside of the treatment site. In some implementations, the treatment site is a buttock, thigh, abdomen, waist, upper arm area, or one of the above.

[0046] In some of the foregoing specific embodiments of this method, the shock wave pulse corresponds to a shock wave. In some implementations, the shock wave pulse has a wavefront of less than 100 nanoseconds. Alternatively, the shock wave pulse has at least 0.015 millijoules per square millimeter or at least 0.3 millijoules per square millimeter. In some such implementations, the shock wave pulse is between 0.1 millijoules per square millimeter and 5 millijoules per square millimeter, or between 0.4 millijoules per square millimeter and 1.5 millijoules per square millimeter. In some implementations, for example when causing disruption of the fibrous extracellular matrix structure of tissue, the shock wave pulse is between 0.020 millijoules per square millimeter and 0.035 millijoules per square millimeter. In a particular implementation, the shock wave pulse has 0.027 millijoules per square millimeter.

[0047] In some of the foregoing embodiments of this method, the shock wave pulse has a pulse repetition frequency of at least 10 Hz. In some implementations, the shock wave pulse has a pulse repetition frequency between 20 Hz and 1000 Hz.

[0048] In some of the foregoing embodiments of the present invention, the shock wave pulse propagates through a shock wave exit window having an area of ​​0.5 square centimeters to 20 square centimeters. Alternatively, the shock wave pulse is substantially a plane shock wave.

[0049] In some of the foregoing embodiments of the present invention, the shock wave pulses are emitted via a probe comprising an electro-hydraulic generator. In some implementations, the probe includes a fluid-filled chamber and a plurality of electrodes arranged within the chamber to define one or more spark gaps, wherein the plurality of electrodes are arranged to receive a plurality of voltage pulses from a pulse generation system, causing a plurality of portions of the liquid in the fluid-filled chamber to vaporize and propagate a plurality of shock waves via the liquid to a shock wave outlet window or a vacuum head in contact with the processing area.

[0050] In some of the foregoing embodiments of the invention, the probe includes a housing arranged to accommodate a plurality of electrodes and define a fluid-filled chamber, wherein the housing includes a free-form acoustic reflector surface defining the chamber. In some implementations, the shockwave pulse is radiated to the treatment site for a treatment time between 1 and 40 minutes. Alternatively, treatment for the treatment site occurs at least once every two weeks to once every twelve weeks.

[0051] Some specific embodiments of this system (e.g., a vacuum system) include: a control unit configured to connect to a pump; a conduit configured to connect to the control unit and a vacuum head; and a vacuum head configured to connect to a processing section, the vacuum head including: a vacuum head housing, a compliant member, one or more sensors, and one or more lamps. The vacuum head housing defines a window and one or more ports. The compliant member is connected to the vacuum head housing. One or more sensors are connected to the vacuum head housing. One or more lamps are connected to the vacuum head housing.

[0052] In some of the aforementioned embodiments of this system, the system further includes a pump. In some implementations, the control unit is integrated with the pump, and the vacuum head is configured to assist in ultrasonic subcutaneous cutting by lifting the skin of the tissue site into the vacuum head.

[0053] In some of the aforementioned embodiments of this system, the compliant member includes a photopolymer flange arranged to attach to a processing site and establish a seal between the processing site and the vacuum head. In other implementations, the compliant member includes an overmolded flange arranged to attach to a processing site and establish a seal between the processing site and the vacuum head. In some such implementations, the photopolymer flange or overmolded flange has a Shore A hardness of 30 to 50.

[0054] In some of the aforementioned embodiments of this system, one or more sensors are deployed to generate data indicating the vacuum state of the vacuum head.

[0055] In some implementations, one or more lamps are arranged to illuminate a processing area, indicate the vacuum status of a vacuum head, or both. Alternatively, one or more sensors include a pressure sensor, an infrared sensor, or both.

[0056] In some of the aforementioned specific embodiments of this system, the control unit further includes: a valve, a motor, an indicator, and a controller. The motor is connected to the valve and configured to adjust the valve. The indicator is configured to output an indication corresponding to the position of the valve. The controller is configured to transmit a plurality of control signals to the motor and the indicator.

[0057] Some specific embodiments of this system (e.g., a vacuum system) include: an integrated vacuum device configured to connect to a pump. The integrated vacuum device includes: a body and a vacuum head. The body defines one or more ports and one or more through channels. The vacuum head is connected to the body and faces one or more ports. The vacuum head includes: a vacuum head housing, a compliant member, one or more sensors, and one or more lamps. The vacuum head housing defines a window and one or more ports. The compliant member is connected to the vacuum head housing. One or more sensors are connected to the vacuum head housing. One or more lamps are connected to the vacuum head housing. In some of the foregoing embodiments of this system, the system further includes a pump. Alternatively or as an alternative, the vacuum head is configured to assist in ultrasonic subcutaneous cutting by lifting the skin of a tissue site into the vacuum head.

[0058] In some of the aforementioned embodiments of this system, the compliant member includes a photopolymer flange arranged to attach to a processing site and establish a seal between the processing site and the vacuum head. In other implementations, the compliant member includes an outer mold flange arranged to attach to a processing site and establish a seal between the processing site and the vacuum head. In some such implementations, the photopolymer flange or outer mold flange has a Shore A hardness of 30 to 50.

[0059] In some of the aforementioned embodiments of this system, one or more sensors are deployed to generate data indicating the vacuum state of the vacuum head.

[0060] In some implementations, one or more lamps are arranged to illuminate a processing area, indicate the vacuum status of a vacuum head, or both. Alternatively, one or more sensors include a pressure sensor, an infrared sensor, or both.

[0061] In some of the aforementioned specific embodiments of this system, the main body further includes a control unit, which includes: a valve, a motor, an indicator, and a controller. The motor is connected to the valve and configured to adjust the valve. The indicator is configured to output an indication corresponding to the position of the valve. The controller is configured to transmit a plurality of control signals to the motor and the indicator.

[0062] Some specific embodiments of this device (e.g., a sonic subcutaneous cutting device) include: a housing, a pulse generating system, and a controller. The pulse generating system is connected to the housing. The controller is connected to the pulse generating system and configured to cause the pulse generating system to generate a plurality of shock wave pulses. The shock wave pulses are configured to cause disruption of the fibrous extracellular matrix structure of the tissue.

[0063] In some of the aforementioned embodiments of this device, the shock wave pulse is unfocused and non-cavitating. In some of the aforementioned embodiments of this device, the shock wave pulse has a negative pulse component of less than 2 microseconds. In some such implementations, the shock wave pulse has a negative pulse component of less than 1 microsecond. In other such implementations, the shock wave pulse has a negative pulse component of less than 0.5 microseconds.

[0064] Some specific embodiments of this method (e.g., a method for treating a human or animal tissue state by inducing tissue fragmentation using a plurality of non-cavitation rapid acoustic pulses) include: identifying a treatment site; and applying a series of shock wave pulses to the treatment site.

[0065] In some of the foregoing embodiments of this method, the treatment site includes a scar, a hypertrophic scar, or an implant capsule contraction. In some of the foregoing embodiments of this method, the treatment site includes a fibrous plaque. In some of the foregoing embodiments of this method, the treatment site includes a fibrous tissue-generating organ.

[0066] In some of the foregoing embodiments of this method, the fast acoustic pulse is unfocused. In some of the foregoing embodiments of this method, the fast acoustic pulse is substantially planar.

[0067] In some of the aforementioned embodiments of this device, the fast acoustic pulse has a negative pulse component of less than 2 microseconds. In some such implementations, the fast acoustic pulse has a negative pulse component of less than 1 microsecond. In other such implementations, the fast acoustic pulse has a negative pulse component of less than 0.5 microseconds.

[0068] The term "coupled" is defined as "connected," but not necessarily directly and mechanically connected; the two objects "coupled" may be separate entities. The terms "a" and "an" are defined as one or more, unless otherwise expressly required in this case. The term "substantially" is defined as most, but not necessarily all (and includes) the designated; for example, substantially 90 degrees includes 90 degrees, and substantially parallel includes parallel, as those skilled in the art will understand. In any disclosed specific embodiment, the terms "substantially," "nearly," and "approximately" may be replaced by "within" "a percentage" of the designated, where percentage includes 0.1%, 1.5%, and 10 percent.

[0069] The terms "comprise" (and any form of inclusion, such as "it includes" and "it includes"), "have" (and any form of having, such as "it has" and "it has"), "include" (and any form of inclusion, such as "it includes" and "it contains"), and "contain" (and any form of containment, such as "it contains" and "it contains") are open-ended linking verbs. As a result, a system or apparatus that "comprises," "has," "includes," or "contains" one or more elements has, but is not limited to having only, the aforementioned elements. Similarly, a method that "comprises," "has," "includes," or "contains" one or more steps has, but is not limited to having only, the aforementioned steps.

[0070] Any specific embodiment of any of this system, apparatus, and method may consist of, or substantially consist of (rather than include / contain / include / have) the described steps, elements, and / or features. Therefore, in any claim, the terms "consist of" or "substantially consist of" may be replaced by any of the open-ended conjunctions stated above, so as to change the scope of a given claim from that which originally used the open-ended conjunction.

[0071] Furthermore, a structure (e.g., a component of a device) arranged in a particular manner is arranged at least in the manner described above, but may also be arranged in other manners not explicitly described.

[0072] Detailed designs and other descriptions associated with the specific embodiments described above will be presented below. Attached Figure Description

[0073] The following figures are illustrative and non-limiting. For simplicity and clarity, not every feature of a given structure is always labeled in every figure in which that structure appears. Identical reference numerals do not necessarily indicate identical structures. Rather, identical reference numerals can be used to indicate similar features or features with similar functions, and non-identical reference numerals can serve the same purpose. The figures are drawn to scale (unless otherwise specified), meaning that the sizes of the depicted elements are relatively accurate relative to at least the specific embodiments depicted in the figures.

[0074] Figure 1 A block diagram depicting an example of an acoustic subcutaneous cutting system used to provide acoustic subcutaneous cutting to target tissue.

[0075] Figure 2A Describing can be borrowed Figure 1 The waveform of the system radiating into the target tissue.

[0076] Figure 2B Describe the reference waveform used for mechanical waves.

[0077] Figure 2C Depict a comparison between the waveforms of focused seismic waves and pressure waves.

[0078] Figure 2D Depicting another possible Figure 1 The waveform of the system radiating into the target tissue.

[0079] Figure 2E Depicting another possible Figure 1 The waveform of the system radiating into the target tissue.

[0080] Figure 3 A block diagram depicting an example of an acoustic subcutaneous cutting device that generates electro-hydraulic (EH) shock waves.

[0081] Figure 4 A cross-sectional side view of a handheld probe of some specific embodiments of a local acoustic wave subcutaneous cutting device for generating electro-hydraulic shock waves is depicted.

[0082] Figures 5A to 5B A timing diagram illustrating an example of the timed application of energy cycles or voltage pulses in the system of this acoustic subcutaneous cutting device.

[0083] Figure 6 A diagram depicting a free-form reflector and a sound wave.

[0084] Figure 7 and Figure 8 Depict both isometric views and cross-sectional views of the spark head portion of one of the sonic subcutaneous cutting devices.

[0085] Figure 9 A cross-sectional view depicting an example of an acoustic subcutaneous cutting device, which is used for electro-hydraulic generation of an acoustic wave with an improved acoustic wavefront.

[0086] Figure 10 Depicting Figure 9 A three-dimensional diagram of some specific components of the ultrasonic subcutaneous cutting device.

[0087] Figures 11A to 11C Depict three views, showing Figure 10 The functionality of the components.

[0088] Figure 12 A schematic diagram illustrating an example of a vacuum system.

[0089] Figure 13 A three-dimensional diagram depicting an example of a controller for a vacuum system.

[0090] Figure 14 Depicting Figure 13A 3D semi-transparent view of a controller example.

[0091] Figure 15 A three-dimensional diagram depicting an example of a vacuum head in a vacuum system.

[0092] Figures 16A to 16E Additional views are depicted, illustrating an example of a vacuum head in a vacuum system.

[0093] Figure 17A and Figure 17B Two views are depicted, illustrating an example of an integrated vacuum system for a sonic subcutaneous cutting system.

[0094] Figure 18 A flowchart is drawn to illustrate an example of a method for treating patients using a sonic subcutaneous cutting device to improve the appearance of cellulite.

[0095] Figure 19 A flowchart is drawn to illustrate an example of a method to improve the appearance of cellulite by using rapid sonic pulses to break down fibrous structures in a patient.

[0096] Figure 20A and Figure 20B Photographs depicting two glass slides, illustrating a comparison of fibrous diaphragms.

[0097] Figure 21A and Figure 21B Photographs of two glass slides are shown, illustrating a comparison of fibrous diaphragms.

[0098] Figure 22A and Figure 22B Photographs of two glass slides are shown, illustrating a comparison of fibrous diaphragms.

[0099] Figure 23A and Figure 23B Two photographs depict the patient before and after treatment with a sonic subcutaneous cutting device. Figure 23A ) and after ( Figure 23B A comparison of orange peel tissue.

[0100] Figure 24A and Figure 24B A photograph of a glass slide depicting a fibrous diaphragm.

[0101] Figure 25A and Figure 25B Photographs of two glass slides are depicted, illustrating a comparison of the distribution of fibrous diaphragm and new blood vessels.

[0102] Figure 26 A photograph of a glass slide depicts the distribution of new blood vessels in the fibrous diaphragm.

[0103] Figure 27A and Figure 27BTwo photographs are depicted, showing a comparison of the fibrous diaphragm and the distribution of new blood vessels.

[0104] Figure 28A and Figure 28B Two photographs are depicted, illustrating a comparison of fibrous diaphragms and the distribution of new blood vessels in the muscle.

[0105] Figure 29A and Figure 29B The two photographs depict a comparison of dermal collagen.

[0106] Figure 30A and Figure 30B The two photographs depict a comparison of dermal collagen. Detailed Implementation

[0107] Specific embodiments of this invention refer to systems, apparatus, and methods for using high-frequency shock waves to break up the fibrous extracellular matrix of target tissue. In some embodiments, high-frequency shock waves are applied to the skin to sever hardened (e.g., rigid and unresponsive) fibrous septa in subcutaneous fat. Breaking up and / or severing fibrous septa in subcutaneous fat can lead to an improvement in the appearance of cellulite (e.g., smoother skin). Breaking up and / or severing fibrous septa in subcutaneous fat is a physical effect not produced by conventional sonic therapy or other non-invasive therapies.

[0108] The high-frequency shock waves described herein also produce or cause biological effects similar to those of conventional sound wave therapy, such as collagen regeneration, angiogenesis, lymphangiogenesis, and inflammation inhibition. In some specific embodiments, the applied shock waves are applied at a specific frequency and magnitude to a dermal ridge, depression, or defect, causing the shock waves to break up the hardened diaphragm corresponding to the ridge, depression, or defect. In some specific embodiments, the medical and cosmetic methods of treatment can reduce unwanted side effects and total time to treatment (TTPT) compared to known systems. Furthermore, this shock wave therapy can be used non-invasively, significantly reducing complications, shortening the time between treatments, and increasing patient comfort.

[0109] The ability to cause physical effects (disruption) in the fibroblast extracellular matrix depends on four factors: (1) the intensity of the applied pulse (Pascal), (2) the frequency of the pulse (Hertz), (3) the waveform shape (e.g., wavefront rise time and duration (nanoseconds)), and (4) the duration of exposure. One or more of these factors can be manipulated to cause disruption of the fibroblast extracellular matrix in subcutaneous fat. Furthermore, the ability to induce a tissue response depends on limiting or eliminating cavitation caused by mechanical waves.

[0110] In some specific embodiments of this device, an acoustic subcutaneous cutting device is provided that uses high-frequency shock waves (i.e., rapid acoustic pulses (RAP)) to penetrate the skin to break down fibrous structures that cause cellulite and other fibrous tissue defects. The acoustic subcutaneous cutting device is non-invasive. As a result, the risks of anesthesia, infection from puncture wounds, and long recovery times are eliminated.

[0111] In some specific embodiments, a plurality of fast acoustic pulses comprise a plurality of high-frequency shock waves at a pulse repetition frequency between 10 Hz and 200 Hz, delivering more than 500 to 60,000 acoustic pulses per processing location over a duration. Each high-frequency pulse (i.e., the wavefront of the high-frequency pulse) has a rise time of less than 500 nanoseconds and an average peak output pressure between 1 MPa and 50 MPa. In a preferred embodiment, a plurality of fast acoustic pulses comprise a plurality of high-frequency shock waves provided at a pulse repetition frequency between 50 Hz and 100 Hz, providing more than 500 to 30,000 acoustic pulses per processing location over a duration, wherein each acoustic wave has a rise time of less than 100 nanoseconds and an average peak output pressure between 2 MPa and 15 MPa.

[0112] Biological effects result from mechanotransduction, in which cells translate mechanical signals into cellular biological events, such as gene expression of extracellular matrix components (e.g., collagen) (Wang, Thampatty, Lin, and Im, 2007). When cells are exposed to various micromechanical stimuli, transmembrane integrins transfer mechanical forces from the extracellular matrix (ECM) to the cytoskeleton. This initiates a signal transduction sequence, which in turn alters cytoskeleton function and induces extracellular matrix remodeling (Bae, 2017).

[0113] The rapid acoustic pulse waves of this invention can induce a physical effect of fibrous structure fragmentation (i.e., subcutaneous cutting), where the fibrous structure constitutes the extracellular matrix or, in the case of subcutaneous tissue, a fibrous septum. These physical effects are caused by the shearing of the fibrous structure.

[0114] Rapid rise times (less than 500 nanoseconds) and high average peak output pressures (1 MPa to 50 MPa) of high-frequency wavefronts are used to induce shear-induced tissue damage. The greater the pressure gradient, the more tissue damage occurs (Lokhandwalla, McAteer, Williams, and Sturtevant, 2001). Importantly, although vibration-induced shear can cause damage, individual high-frequency sound waves do not produce sufficient shear to induce damage (Freund, Colonius, and Evan, 2007).

[0115] To generate sufficient tissue damage from shearing, multiple sonic shockwaves need to be applied to the treatment site. For example, in Howard's paper on the mechanical effects of focused shockwaves on tissue-mimicking structures, membrane damage was observed to gradually increase with the number of shockwaves. For instance, kidney injury initiated during lithotripsy by shockwaves spread throughout the focal region of the renal parenchyma after 1000 or 2000 shockwaves. (Howard & Sturtevant, 1997)

[0116] However, it is not only the number of shock waves that is important in affecting tissues. For example, if 1,000 shock waves are delivered to a kidney over several hours or days, any tissue damage will be negligible. Therefore, in addition to the number of sound pulses, the frequency of the sound pulses delivered to the tissue is a determining factor.

[0117] One prime example of this is that human skin is an anisotropic, nonlinear elastic, and loading-history-dependent material (Jookaki and Panzer, 2018). At a given frequency of acoustic pulse repetition, the slower the tissue relaxation time, the greater the tissue degradation that begins with cumulative vibration-induced shear ("cumulative shear mechanism") (Freund, Colonius, and Evan, 2007). This is because when the pulse system is applied to the tissue at a frequency slower than the tissue relaxation time, there is typically no cumulative damage. However, when the pulse system is applied to the tissue at a frequency faster than the tissue relaxation time, membrane damage is observed to gradually increase with the number of shock waves (Howard and Sturtevant, 1997).

[0118] Remarkably, the sonic subcutaneous cutting device described herein delivers more than 500 to 30,000 sonic pulses per treatment area by applying high-frequency shock waves at a pulse rate between 10 Hz and 200 Hz for a duration, thereby breaking down the fibrous structure of the skin. Each high-frequency shock wave (e.g., the wavefront of the high-frequency shock wave) has a rise time of less than 500 nanoseconds and an average peak output pressure between 1 million Pascals and 50 million Pascals. As a result, in one specific embodiment, significant improvement in cellulite can occur in a single treatment visit.

[0119] In some specific embodiments, a method of treating a patient to break down a fibrous diaphragm in the subcutaneous fat of the treatment area may include: guiding a shock wave generating probe (such as probe 38 or 38a described below) to expose an external area of ​​the patient to a series of shock waves, wherein the shock wave generating probe includes a shock wave exit window, wherein the shock wave generating probe is arranged to generate at least 0.01 millijoules per square millimeter or at least 0.3 millijoules per square millimeter at the shock wave exit window. For example, the shock waves may have values ​​or ranges of 0.01, 0.015, 0.02 ... 0.5, 0.6, 0.8, 0.9, 1, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8, 3, 3.4, 3.8, 4, 4.4, 4.8, 5, 5.5, 6, 6.5, 7 millijoules per square millimeter, or any value or range between the above values. In some specific embodiments, the seismic wave generating probe is configured to generate between 0.4 millijoules per square millimeter and 1.5 millijoules per square millimeter. In some specific embodiments, the seismic wave exit window has an area of ​​0.5 square centimeters to 20 square centimeters. For example, the exit window may have an area of ​​at least 0.5, 0.8, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 square centimeters, or any value or range between the above.

[0120] In some embodiments, the shock waves are unfocused and substantially planar before entering the patient's treatment area. In some embodiments, one or more shock waves are directed to the depth of adipose tissue. In some embodiments, one or more shock waves are directed to the depth of the target tissue.

[0121] In some embodiments, the treatment area is a portion of the genitals, buttocks, thighs, stomach, waist, and / or upper arm. In some embodiments, the subcutaneous fat treatment area is at a depth of 0 to 6 cm from the outer area, such as 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 6 cm, or any value or range between these values. In some embodiments, the treatment area is at a depth of 0.1 to 4 cm.

[0122] In some embodiments, the treatment area is a portion of the peripheral vascular distribution. In some embodiments, the treatment area for the peripheral vascular distribution is within a depth of 0 to 6 cm from the outer region, such as 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 6 cm, or any value or range between these values. In some embodiments, the treatment area is at a depth of 0.1 to 4 cm.

[0123] In some embodiments, the processing area is part of the musculoskeletal system. In some embodiments, the processing area of ​​the musculoskeletal system is located at a depth of 0 to 6 cm from the outer region, for example, 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 6 cm, or any value or range between these values. In some embodiments, the processing area is located at a depth of 0.1 to 4 cm.

[0124] In some embodiments, the treatment area is part of the hepatic portal system. In some embodiments, the treatment area of ​​the hepatic portal system is at a depth of 0 to 6 cm from the outer region, for example, 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 6, 12, 20 cm, or any value or range between these values. In some embodiments, the treatment area is at a depth of 0.1 to 4 cm.

[0125] Please refer to Figure 1 The diagram shows a block illustration of an example of a sonic subcutaneous cutting system 100. Figure 1 The sonic subcutaneous cutting system 100 includes a sonic subcutaneous cutting device 110 and an optional vacuum system 112. The sonic subcutaneous cutting system 100 is configured to apply therapeutic or medical treatment to a patient's tissue site 150. The sonic subcutaneous cutting device 110 is configured to generate and apply shock wave pulses 132 to the tissue site 150.

[0126] The acoustic subcutaneous cutting device 110 includes a probe 120, a reflector head 122, and a controller 124. Figure 1 In the diagram, the reflector head 122 and controller 124 are shown separate from the probe 120. However, in other implementations, the reflector head 122, controller 124, or both may be integrated with the probe 120. The probe 120 is positioned to generate a shock wave and apply it to the reflector head 122. The reflector head 122 is positioned to focus or disperse the received shock wave to form a shock wave pulse 132 and to guide the shock wave pulse 132 to the tissue site 150. The controller 124 is positioned to control (e.g., activate) the probe 120 and selectively adjust the reflector head 122. Further details of the acoustic subcutaneous cutting device 110 and its components will be referenced. Figure 3, Figure 4 , Figure 6 and Figures 9 to 11C For clarification. The shockwave pulse 132 will refer to... Figure 2A and Figure 2B Further explanation is needed.

[0127] Vacuum system 112 may include one or more components arranged to generate negative pressure, commonly known as a "vacuum". Vacuum system 112 is arranged to be applied to tissue site 150 and to "pull" tissue 192 upward toward the sonic subcutaneous cutting device 110 and away from the patient's body (e.g., to establish negative pressure or suction for lifting). See reference Figures 12 to 16B A further example of a vacuum system 112 is provided. Although the term vacuum system is used, in some implementations a vacuum system may be a single device.

[0128] The vacuum system 112 can enhance the application effectiveness of the shock wave pulse 132. For example, the vacuum system 112 can pull more than 150 layers of tissue away from other parts of the patient's body, such as bone, organs, and other tissues. This is because the shock wave pulse 132 can be guided to… Figure 1 The multiple layers of tissue site 150 illustrated in the figure, such as tissue 192 to subcutaneous fat 198, and the shock wave pulse 132 may dissipate (e.g., disperse) or weaken (reduce peak output pressure) when the shock wave pulse 132 propagates to (e.g., reaches) other parts or portions of the patient's body (e.g., non-pre-determined treatment areas, such as bone, internal organs, muscle tissue, etc.).

[0129] Tissue site 150 includes tissue 192 (e.g., dermis or skin), subcutaneous fat 194, 198, and fibrous septum 196. For example... Figure 1 As illustrated, below tissue 192 are one or more layers of subcutaneous fat 194, 198. Subcutaneous fat 194, 198 can be arranged in multiple compartments and separated by fibrous diaphragms 196.

[0130] A sonic subcutaneous cutting device 110 is deployed to rupture the fibrous diaphragm 196 by applying shockwave pulses 132. The pulses 132 (e.g., multiple pulses) can be based on... Figure 5A and Figure 5B The application of the illustrative diagram will be further explained in this article. The reason is that the sonic subcutaneous cutting system 100 is deployed to non-invasively create or induce physical effects in the tissue site 150, and the external surface of the tissue site 150 (e.g., smoothness) will be improved.

[0131] Please refer to Figures 2A to 2E , Figures 2A to 2E The diagram illustrates the waveforms of various types of mechanical waves, such as ultrasonic / pressure waves and shock waves. Figures 2A to 2E Each figure shows the seismic wave, and Figures 2A to 2C The diagram also illustrates pressure waves.

[0132] Figures 2A to 2E Rapid sonic pulses can create physical effects and promote healing through compressive force (i.e., positive pressure). Figure 2A , Figure 2D and Figure 2E Rapid acoustic pulses can further promote healing by inducing a tissue response, such as angiogenesis, which is unrelated to or unaffected by cavitation caused by negative pressure and / or pressure fluctuations.

[0133] Please refer to Figure 2A The oscilloscope reading image compares the time-overlapping fast acoustic pulses (pulse 200) with the non-fast acoustic pulses (waveform 250). The vertical axis describes pressure and the horizontal axis describes time. The vertical axis is in megapascals and the horizontal axis is in microseconds.

[0134] exist Figure 2A The diagram illustrates the waveform of a shock wave (i.e., pulse 200) that can be emitted from a probe (e.g., probe 120) and enter a large tissue mass. The depicted waveform, a rapid acoustic pulse (RAP), can create a physical effect: shearing within the tissue. To illustrate, when applied at a rate higher than the tissue relaxation rate, the tension induced in the tissue by the repetitive pulses (e.g., the shock wave) will cumulatively increase. Once a known critical tension is reached, the tissue breaks down under the pressure induced by these pulses, i.e., it shears apart.

[0135] Pulse 200 illustrates an example pulse shape of a pulse generated by the electro-hydraulic (EH) spark head described later. For example, pulse 200 has a high peak output pressure of 9.6 megapascals illustrated, a rapid rise time (or wavefront rise time) of less than 100 nanoseconds (0.1 microseconds) illustrated, a short duration of less than 500 nanoseconds (0.5 microseconds) illustrated, and a very short ring down period with fluctuations of extremely small negative amplitude illustrated.

[0136] also, Figure 2A A demonstrative waveform (i.e., waveform 250) of a non-fast acoustic pulse device is depicted for comparison. Waveform 250 is a pressure wave with a peak output pressure of approximately 1 million Pascals and a rise time of approximately 5,000 nanoseconds (5 microseconds). Waveform 250 has a non-zero peak output of 1 million Pascals or less during a relatively long duration, such as more than 35 microseconds.

[0137] Please refer to Figure 2BThe diagram illustrates reference waveforms for a shock wave and a pressure wave. Pressure waves and shock waves are different types of mechanical waves. Each different wave type has different subtypes, such as focused or planar shock waves, and focused or radial pressure waves. Pulse 200 is an example of an unfocused or planar shock wave, and waveform 250 is an example of a radial pressure wave. Planar shock waves (e.g., unfocused, planar shock waves) often have therapeutic effects at depths of 0.1 to 5.5 cm in the body. Focused shock waves can be effective at depths up to 12 cm. Pressure waves often have therapeutic effects at depths up to 3 cm in the body.

[0138] In some implementations, the energy flux density of the plane wave (e.g., pulse 200) at the skin surface is 0.01 to 0.4 millijoules per square millimeter. Alternatively, the positive peak output pressure of the plane wave (i.e., pulse 200) is often 30 megapascals or less. For reference, focused waves can have an energy flux density of 1.5 millijoules per square millimeter or greater and a positive peak pressure of 100 megapascals or greater, while radial pressure waves can have an energy flux density of up to 0.3 millijoules per square millimeter and a positive peak pressure of up to 10 megapascals.

[0139] exist Figure 2B The diagram shows a typical rapid acoustic pulse 260 (e.g., a shock wave pulse, such as pulse 200) and a typical pressure waveform 265 (e.g., a pressure wave pulse) side-by-side for selective illustration and comparison. Pulse 260 illustrates another example pulse shape of pulsation generated by an electro-hydraulic (EH) spark head, as described below. Figure 2B In the process, the rapid acoustic pulse 260 has a pulse duration of 0.5 microseconds, and the pressure waveform 265 has a pulse duration of 500 microseconds.

[0140] Please refer to Figure 2C The figure shows a comparison between a focused seismic wave pulse 270 and an ultrasonic pressure waveform 275. Figure 2C The diagram shows a focused shock wave pulse 270, which has a relatively large negative pressure amplitude. Figure 2C The diagram illustrates a compression zone that promotes cellular and tissue activity. This compression zone corresponds to an area where the focused shockwave pulse 270 exhibits / induces positive pressure within a negative pressure segment and before the ringing flow. Cellular and tissue activity can be induced by this compression zone, which has a duration of several microseconds.

[0141] Figure 2CThe diagram also illustrates a cavitation region that promotes cellular activity. This cavitation region corresponds to the area where the focused shock wave pulse 270 has / induces negative pressure after the positive pressure section and before the ringing flow. Cellular activity can be induced by a cavitation region with a duration exceeding 2 microseconds. Similar to pressure waves 250 and 265, ultrasound 275 produces cavitation, but this cavitation is minimal compared to that produced by the focused shock wave pulse 270.

[0142] To illustrate, cavitation bubbles begin to form during the negative pressure pulse at the tail end of a shock wave. Conventional shock waves (including focused shock wave pulses 270) have a negative pressure region lasting longer than 2 microseconds, allowing cavitation bubbles sufficient time to grow to their maximum size. As a result, cavitation bubbles can grow to a large size before collapsing, enabling the collapse to be powerful enough to cause tissue fragmentation.

[0143] Please refer to Figure 2D The illustration shows a typical compression fast acoustic pulse 280 with a compressed or reduced negative pulse component. Pulse 280 illustrates another example pulse shape of pulsation generated by an electro-hydraulic (EH) spark head, as described below. Compared to a focused shock wave such as focused shock wave pulse 270 and fast acoustic pulses such as fast acoustic pulses 200 and 260 (e.g., unfocused shock waves), the compression fast acoustic pulse 280 has a compression negative pressure component, i.e., a reduced time amount of time during which the pulse has negative pressure and / or a reduced peak negative pressure (megapascal).

[0144] like Figure 2D As illustrated, the duration of the negative pulse (e.g., the duration of the negative pulse component) is 560 nanoseconds (0.560 microseconds). Compared to Figure 2C The duration of the negative pulse is 5 microseconds (5000 nanoseconds). Figure 2D The duration of the negative pulse is shortened. The shortened duration of the negative pulse significantly reduces or eliminates cavitation. That is, since the limited negative pressure time cannot provide enough time for cavitation bubbles to grow to the size that would cause tissue fragmentation, the effects of cavitation on the skin are reduced or eliminated.

[0145] Please refer to Figure 2E The figure illustrates a comparison between a conventional fast acoustic pulse 290 and a compressed fast acoustic pulse 295 to further describe the fast acoustic pulse compression described herein compared to the conventional fast acoustic pulse. Pulse 295 illustrates another example pulse shape of the pulsation generated by the electro-hydraulic (EH) spark head, as described below. Figure 2EAs illustrated, the compressed fast acoustic pulse 295, compared to the conventional fast acoustic pulse 290, has a shorter total duration and a faster rise time at similar peak positive pressure. Furthermore, the compressed fast acoustic pulse 295 has a reduced peak negative pressure compared to the conventional fast acoustic pulse 290. More specifically, the compressed fast acoustic pulse 295 has a reduced or compressed negative pressure time compared to the conventional fast acoustic pulse 290. Specifically, the long duration acoustic tail of the compressed fast acoustic pulse 295 is significantly reduced compared to the duration of the acoustic tail of the conventional fast acoustic pulse 290. This compressed fast acoustic pulse 295 can be generated by a two-stage method, as described in reference patent PCT / US2017 / 704212.

[0146] The compressed rapid acoustic pulse 295 is compressed, making the negative tensile pressure region of the shock wave less than 1 microsecond. For example... Figure 2E As shown, the duration of the negative pressure pulse at the tail of the compressed rapid sonic pulse 295 is 0.560 microseconds, while the duration of the negative pressure pulse at the tail of the conventional rapid sonic pulse 290 is greater than 2 microseconds. Because the negative tensile pressure region of the shock wave is less than one microsecond, when the compressed rapid sonic pulse 295 is applied, cavitation bubbles do not form or cannot grow to a sufficient size to cause the collapse of the cavitation bubbles, resulting in tissue damage and pain.

[0147] Compared to conventional shockwave pulses, compressed rapid acoustic pulses or rapid acoustic pulses with compressed and / or reduced negative pressure components, such as rapid acoustic pulse 200, compressed rapid acoustic pulse 280, and compressed rapid acoustic pulse 295, can cause tissue disruption, leading to or promoting tissue responses, such as angiogenesis. These rapid acoustic pulses (e.g., rapid acoustic pulse 200, compressed rapid acoustic pulse 280, and compressed rapid acoustic pulse 295) may not cause or induce cellular responses, for example, through cavitation effects. Specifically, reduced negative pressure and a reduced duration of negative pressure in the rapid acoustic pulses described herein will reduce cavitation and the resulting effects. For example, a higher degree of cavitation can cause unnecessary thermal effects, pain, etc. Therefore, the rapid acoustic pulses generated by the sonic subcutaneous cutting device described herein can induce strong tissue responses from mechanical tissue disruption without cavitation, thus promoting painless use of acoustic waves (e.g., unfocused shockwaves) in treatment.

[0148] One example of tissue response is fibrosis reduction. Normal wound healing requires myofibroblasts for tissue repair. However, in pathological conditions, activated myofibroblasts become the primary or key effector of impaired fibrosis. To maintain repair, regeneration, and regeneration stability after injury, resident fibroblasts are activated and transform into myofibroblasts (Bae, 2007). In the progression of fibrosis, mechanical stress in the surrounding microenvironment is an important mediator of myofibroblast differentiation (Bae, 2007).

[0149] For fibroblasts and myofibroblasts, mechanical stress can indirectly regulate the production of extracellular matrix proteins by stimulating the release of paracrine growth factors, or directly by triggering an intracellular signaling pathway that activates genes producing extracellular matrix proteins and growth factors (Chiquet, Renedo, Huber, and Flack, 2003). Focal adhesions at the cell surface allow the mechanical tension generated in the system to be transduced to the cytoskeleton network. These changes establish sensitivity to mechanical tension, which is transmitted to the cell by signaling (e.g., by opening Ca1 channels) to glycoproteins, primarily fibronectin. Fibronectin, acting as a ligand, attaches to integrins, transmitting the signal from the extracellular matrix to the cytoplasm. Smad3 and Smad4 signals from the cytoplasm are stimulated by tension to form a complex. The complex is added to the nucleus to initiate TGF-β1 stimulation, collagenogen formation, collagen formation, fibroblast differentiation into myofibroblasts, and traumatic contraction with excessive type III collagen protein (Widgerow, 2011).

[0150] The biomechanical properties of the extracellular matrix, particularly alterations in stiffness, can be an important therapeutic target, as they can modulate myofibroblast formation and fibroblast generation (Bae, 2017). Studies suggest that fibroblasts cultured on low-modulus substrates maintain a normal phenotype. However, when cultured on high-modulus substrates, fibroblasts activate into myofibroblasts (Bae, 2017). Importantly, myofibroblast activation is reversible when cultured on low-modulus substrates. Marinkovic et al. (Marinkovic, Liu, and Tshumperlin, 2013) demonstrated that primitive fibroblasts originating from fibroblast-generating lungs exhibit significantly suppressed contractile and proliferative functions when cultured in soft substrates (e.g., with an elastic modulus of approximately 1 kPa). Based on these results, myofibroblast surface morphology may not be permanent, but can be reversed by altering matrix properties (Bae, 2017) (Marinkovic, Liu and Tshumperlin, 2013).

[0151] Wang et al. (Wang, Haeger, Kloxin, Leinwan, and Anseth, 2012) demonstrated that porcine aortic valve myofibroblasts respond to a decrease in receptor modulus by exhibiting reduced α-smooth muscle actin (α-SMA), stress fiber proliferation, and increased myofibroblast apoptosis. Furthermore, when aortic valve myofibroblasts were cultured on a hard receptor (e.g., with an elastic modulus of 32 kPa, mimicking precalcified tissue), the expression of genes containing α-smooth muscle actin and connective tissue growth factor (CTGF) was significantly upregulated (Wang, Haeger, Kloxin, Leinwan, and Anseth, 2012). Based on these results, Wang et al. (Wang, Haeger, Kloxin, Leinwan, and Anseth, 2012) suggested that the mechanical rigidity of the substrate can modulate the evolution of activated myofibroblasts, leading to a significantly quiescent fibroblast population (Bae, 2017) (Wang, Haeger, Kloxin, Leinwan, and Anseth, 2012). Mechano-based antifibrotic therapy could offer several significant advantages over existing pharmacological approaches. These advantages include the contrast with systemic local / regional activity, ease of dose adjustment and discontinuation, which could potentially provide improved safety and reduced systemic side effects.

[0152] When the unfocused, non-cavitation, rapid-pulse sonic waves described in this article are applied to tissue, tissue structure is disrupted. This disruption results in a loss of mechanical rigidity in these tissue structures. Consequently, activated myofibroblasts found in fibrous tissue can be pushed into a quiescent or apoptotic state, leading to reduced fibrosis. It is believed that the improvement in the appearance of scars after rapid-pulse sonic treatment will be achieved through the microscopic disruption of the scar collagen matrix, leading to a reduction in the mechanical rigidity of the scar matrix. This reduction in the mechanical rigidity of the scar matrix can lead to the quiescent or apoptotic state of myofibroblasts, resulting in improved scar appearance. The high-frequency pulses of rapid-pulse sonic treatment allow for non-invasive scar tissue disruption without cavitation damage or thermal degradation of surrounding tissues, or the pain seen with focused sonic devices.

[0153] When the unfocused, non-cavitation, rapid acoustic pulses described herein are applied to fibrous tissue, fragmentation of the fibrous tissue structure can occur. If the fibrous tissue is scar tissue, the rapid acoustic pulses can cause fragmentation of the scar tissue structure. In one embodiment, non-limitingly, the scar tissue is a keloid scar. In another embodiment, the scar tissue is a hypertrophic scar. In a further embodiment, the scar tissue is tissue adhesion. In yet another embodiment, the scar tissue is implant capsular contraction.

[0154] Another example of tissue response is angiogenesis induction. Angiogenesis is a non-specific response to tissue fragmentation (i.e., injury). Angiogenesis and neovascularization play a central role in the initial stages of wound healing. This angiogenesis response is stimulated by various growth factors released due to tissue fragmentation and inflammatory cell infiltration.

[0155] Vascular endothelial growth factor A (VEGF-A) is a cell-produced signaling protein that stimulates angiogenesis. VEGF-A is essential for adults during organ remodeling and disease processes involving blood vessels, such as wound healing, tumor angiogenesis, diabetic retinopathy, and age-related macular degeneration.

[0156] Vascular endothelial growth factor A (VEGF A) expression is absent in normal skin. However, mechanical disruption of the skin induces an upregulation of VEGF A expression, which is associated with angiogenesis both temporally and spatially. The end result is believed to be increased vascular density in the affected area. This has led to the development of the "angiogenic hypothesis," which posits that the release of VEGF is a non-specific response to tissue damage, a hypothesis that can be established using various methods.

[0157] When the rapid acoustic pulses of this invention are applied to tissue, they cause disruption of the tissue structure. This tissue disruption can lead to the release of vascular growth factors, resulting in the proliferation of new blood vessels.

[0158] As a result, when the unfocused, non-cavitation, rapid acoustic pulses of the present invention are applied to tissue, they can cause fragmentation within the tissue structure, thereby inducing a tissue response that promotes angiogenesis. Non-limitingly, but in one embodiment, the rapid acoustic pulses can be used to induce angiogenesis in non-healing wounds. In another embodiment, the rapid acoustic pulses can be used to induce angiogenesis in the skin. In yet another embodiment, the rapid acoustic pulses can be used to induce angiogenesis in adipose tissue. In yet another embodiment, the rapid acoustic pulses can be used to induce angiogenesis in muscle tissue, such as cardiac muscle tissue. In yet another embodiment, the rapid acoustic pulses can be used to induce angiogenesis in tissues related to reproductive health, such as for erectile dysfunction treatment and vaginal rejuvenation.

[0159] In some embodiments, the shock wave generating probe can emit a shock wave that includes the following waveform characteristics in a transmission medium. The transmission medium can be a tissue (e.g., adipose tissue) or an aqueous solution (e.g., a saline solution with a concentration such as 0.1% to 10%). In some embodiments, the shock wave emitted at the probe exit window and / or delivered to the treatment area can have a wavefront rise time of less than 500 nanoseconds, less than 400 nanoseconds, less than 300 nanoseconds, less than 250 nanoseconds, less than 200 nanoseconds, less than 100 nanoseconds, less than 80 nanoseconds, less than 50 nanoseconds, or less than 20 nanoseconds, as measured in the transmission medium. For example, a shock wave emitted at the probe exit window and / or delivered to the treatment area can have a wavefront rise time of 100 nanoseconds, 200 nanoseconds, 300 nanoseconds, 400 nanoseconds, 500 nanoseconds, etc. In some embodiments, the actual amplitude of the emitted acoustic pulse can be 0.5 to 50 megapascals.

[0160] In some embodiments, the probe emits a shock wave at a pulse repetition frequency (also referred to as a pulse frequency) of at least 10 Hz. For example, the probe emits a shock wave at a pulse repetition frequency between 10 Hz and 1000 Hz, such as 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000 Hz, or any value or range between these values. In some embodiments, the probe emits a shock wave at a pulse frequency between 10 Hz and 100 Hz. In some embodiments, the probe emits a shock wave at a pulse frequency between 20 Hz and 75 Hz. In some embodiments, the probe emits a shock wave at a pulse frequency between 100 Hz and 500 Hz. In some embodiments, the probe radiates a shock wave at a pulse frequency between 500 Hz and 1000 Hz. In some embodiments, the radiated wave is arranged according to the above characteristics to induce a transient cavitation so small as to be undetectable in a transmission medium.

[0161] As a result, the present invention avoids the long treatment times seen in prior art, along with the problems associated with such long treatment times (such as clinic space, cost, discomfort, etc.). For example, in some specific embodiments, a treatment period can be 1 to 60 minutes within a 24-hour period. A treatment period can be 1, 2, 4, 5, 8, 10, 12, 15, 18, 20, 22, 24, 26, 28, 30, 40, 45, 60 minutes, or any value or any range between the above values. A treatment period can include multiple treatment applications, such as multiple treatments applied to different treatment areas / sites within a treatment area or multiple treatments applied to multiple treatment areas. A treatment area can include or correspond to a scar, a dermal ridge, a depression, or cellulite (e.g., grade 2 or higher cellulite). A treatment period can be performed daily, every other day, every three days, weekly, every two weeks, monthly, every two months, and quarterly. A processing schedule may include 1 to 20 time periods within a year, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 time periods, or any number between these values. In some specific embodiments, a processing schedule may include time periods at least once every two weeks for at least six weeks.

[0162] For reference Figure 1The description indicates that the acoustic subcutaneous cutting system 100 includes a shock wave generator. The shock wave generator can be configured to deliver a defocused plane wave having the characteristics described above. In some embodiments, an electro-hydraulic wave is generated. For example, the system and apparatus described in U.S. Patent Publication No. 2014 / 0251744 can be configured to apply an electro-hydraulic shock wave at the described frequency, energy level, and duration. In particular, the shock wave generating apparatus can be configured to generate a planar, defocused shock wave front.

[0163] Please refer to Figure 3 This system may include a handheld probe (e.g., with a first housing, such as...) Figure 4 The device 10 includes a separate controller or pulse generation system (e.g., in or having a second housing, the second housing being connected to a handheld probe via a flexible cable or similar). In the illustrated embodiment, device 10 includes: a housing 14, a liquid 54, a plurality of electrodes, and a pulse generation system 26. Housing 14 defines a chamber 18 and a shock wave outlet 20. Liquid 54 is disposed in chamber 18. A plurality of electrodes (e.g., in spark heads or modules 22) are arranged in the chamber to define one or more spark gaps. Pulse generation system 26 is arranged to apply a plurality of voltage pulses to the electrodes at a frequency between 10 Hz and 1000 Hz (e.g., between 10 Hz and 100 Hz, between 100 Hz and 500 Hz, between 500 Hz and 1000 Hz). In this specific embodiment, the pulse generation system 26 is configured to apply voltage pulses to the electrodes, causing multiple portions of the liquid to vaporize, thereby propagating multiple shock waves through the liquid and the shock wave outlet window.

[0164] In the illustrated embodiment, the pulse generating system 26 is configured for use with an AC power source (e.g., a wall socket). For example, in this embodiment, the pulse generating system 26 includes a plug 30 configured to insert into a 110-volt wall socket. In the illustrated embodiment, the pulse generating system 26 includes a capacitor / inductor coil; an example of the pulse generating system 26 is provided. Figure 7The following is an explanation. In the illustrated embodiment, the pulse generation system 26 is (e.g., removably) connected to the electrodes in the spark head or module 22 via a high-voltage cable 34. The high-voltage cable may, for example, include two or more electrical conductors and / or be reinforced with rubber or other types of electrical insulation material to prevent electric shock. In some embodiments, the high-voltage cable 34 is a composite cable or cable that further includes one or more (e.g., two) liquid lumens through which the chamber 18 can be filled with liquid and / or through which liquid can circulate through the chamber 18 (e.g., via a composite connector 36). In the illustrated embodiment, the device 10 includes a handheld probe or handpiece 38, and the cable 34 is removably connected to the probe 38 via a high-voltage connector 42, which is connected to the spark head or module 22 via two or more electrical conductors 44. In the specific embodiment shown, probe 38 includes a head 46 and a handle 50, and probe 38 may include a polymer or other electrically insulating material to allow an operator to grip the handle 50 to position probe 38 during operation. For example, handle 50 may be molded from plastic and / or coated with an electrically insulating material such as rubber.

[0165] In the illustrated embodiment, liquid 54 (e.g., a dielectric liquid such as distilled water or a conductive liquid such as a brine solution) is disposed in (e.g., substantially filled) chamber 18. In this embodiment, spark head 22 is positioned within chamber 18 and surrounded by liquid, such that the electrode can receive voltage pulses from pulse generation system 26 (e.g., at a frequency between 10 Hz and 1000 Hz, 10 Hz and 100 Hz, 100 Hz and 500 Hz, or 500 Hz and 1000 Hz), causing multiple portions of the liquid to vaporize, and the collapse of the vapor bubbles generates a shock wave that propagates through the liquid and shock wave outlet 20. In the illustrated embodiment, probe 38 includes an acoustic delay chamber 58 located between chamber 18 and outlet 20. In this embodiment, the acoustic delay chamber is substantially filled with liquid 62 (e.g., of the same type as liquid 54) and has a length 66 sufficient to allow shock wave formation and / or guidance to outlet 20. In some embodiments, the length 66 may be between 2 millimeters (mm) and 25 millimeters (mm). In the illustrated embodiment, chamber 18 and acoustic delay chamber 58 are separated by a layer of acoustically permeable (sound waves can pass through or transmit through) material, which allows shock waves to travel from chamber 18 into acoustic delay chamber 58. In other embodiments, liquid 62 may be different from liquid 54 (for example, liquid 62 may include bubbles, water, oil, mineral oil, and / or similar substances). For example, certain characteristics of bubbles may introduce and / or improve the nonlinearity in the acoustic behavior of liquid 54 to increase shock wave formation.

[0166] In another embodiment, chamber 18 and acoustic delay chamber 58 may be monolithic (i.e., may include a single chamber). In yet another embodiment, acoustic delay chamber 58 may be replaced by a solid component (e.g., a solid cylinder of an elastomeric material such as polyurethane). In the illustrated embodiment, probe 38 further includes an exit component 70 removably connected to a housing at one end of the acoustic delay chamber, as shown. Component 70 is positioned to contact an external area located above tissue 74 and is removable and sterilized or replaced between patients. Component 70 comprises a polymer or other material (e.g., low-density polyethylene or polysiloxane) that is acoustically permeable to allow shock waves to exit acoustic delay chamber 58 through exit 20. In some embodiments, acoustic coupling gel (not shown) may be disposed between component 70 and tissue 74 to lubricate and provide additional acoustic transmission into tissue 74.

[0167] In the illustrated embodiment, probe 38 includes an acoustic mirror 78, which comprises a material (e.g., glass) and is arranged to reflect most of the sound waves and / or shock waves incident on the acoustic mirror. As shown, the acoustic mirror 78 may be angled to reflect sound waves and / or shock waves (e.g., shock waves originating from spark head 22) toward outlet 20 (through the acoustic delay chamber) in a defocused manner. In the illustrated embodiment, housing 14 may include a light-transmitting or transparent window 82, which is arranged to allow a user to view (via window 82, chamber 18, chamber 58, and component 70) a region of the patient comprising a plurality of target cells (e.g., tissue 74) (e.g., to position outlet 20 at the target tissue during or before the application of shock waves). In the illustrated embodiment, window 82 comprises an acoustic reflective material (e.g., glass) arranged to reflect most of the sound waves and / or shock waves incident on the window. For example, window 82 may include transparent glass with sufficient thickness and strength to withstand high-energy acoustic pulses generated at spark head 22 (e.g., reinforced flat glass with a thickness of about 2 mm and a light transmission efficiency of more than 50%).

[0168] exist Figure 3 In this context, the human eye 86 refers to the user viewing the target tissue through window 82, but it should be understood that the target tissue can also be "viewed" through window 82 via a camera (e.g., a digital camera and / or video camera). Through direct or indirect observation, sound wave energy can be located, applied, and repositioned based on target tissues such as orange peel areas and sound wave energy indicators such as tissue color changes.

[0169] Figure 4 A cross-sectional side view is depicted of a second embodiment 38a of the handheld probe or handpiece used in some specific embodiments of the electro-hydraulic shock wave generating system and equipment. The housing 14a is, in some forms, connected to... Figure 3 The housing 14a is substantially similar to the outer casing 14a, for example, housing 14a covers or encloses some components of probe 38a. Probe 38a is substantially similar to probe 38 in some aspects, and therefore the differences will be described primarily here. For example, probe 38a is also arranged so that a user viewing the area (e.g., the target tissue) through window 82a and outlet 20a cannot see the plurality of electrodes of spark head 22a. However, probe 38a is arranged so that spark head 22a (and the electrodes of spark head) is deflected from an optical path extending through window 82a and outlet 20a, without including an optical shield. In this specific embodiment, acoustic mirror 78a is positioned between spark head 22a and outlet 20a, as shown, to define the boundary of chamber 18a and to guide acoustic waves and / or shock waves from spark head 22a to outlet 20a. In the specific embodiment shown, since the acoustic mirror 78a is disposed between the window 82a and the chamber 18a and the sound waves and / or shock waves do not directly incident on the window 82a (i.e., since the sound waves and / or shock waves are mainly reflected by the acoustic mirror 78a), the window 82a may include a polymer or other sound wave-permeable or transmissive material.

[0170] exist Figure 4 In the specific embodiment shown, the spark head 22a includes a plurality of electrodes 400 defining a plurality of spark gaps. Using multiple spark gaps is preferable because it doubles the number of pulses delivered in a given period. For example, after a pulse vaporizes some liquid in a spark gap, the vapor must return to a liquid state or be replaced by a different portion of the liquid still in a liquid state. In addition to the time required for the spark gaps to be refilled with water before a subsequent pulse can vaporize additional liquid, the spark also heats the electrodes. Thus, for a given spark rate, increasing the number of spark gaps reduces the frequency at which each spark gap must ignite, and therefore extends electrode life. Thus, ten spark gaps can potentially increase the possible pulse rate and / or electrode life by a factor of ten.

[0171] As mentioned above, high pulse rates can generate significant heat, which can increase electrode fatigue and / or increase the time required for vapor to return to a liquid state after vaporization. In some specific embodiments, heat can be managed by circulating liquid around the spark head. For example, in Figure 4 In a specific embodiment, probe 38a includes a plurality of conduits 404 and 408 extending from chamber 18a to respective connectors 412 and 416, as shown. In this specific embodiment, connectors 412 and 416 are connected to a pump to circulate liquid through chamber 18a (e.g., and through a heat exchanger). For example, in some embodiments, pulse generation system 26 ( Figure 3The device may include a pump and a heat exchanger connected in series and arranged to be connected to connectors 412 and 416 through a plurality of conduits or similar means. In some embodiments, a filter may be included in the probe 38a, in a spark generation system (e.g., pulse generation system 26), and / or between the probe and the spark generation system to filter the liquid circulating through the chamber.

[0172] like Figure 4 As illustrated, each shock wave applied to a target tissue includes a wavefront 418 that propagates from an exit 20a and travels outward through the tissue 74. As shown, the wavefront 418 is curved according to its outward expansion and, in part, according to the shape of the outer surface of the exit member 70a in contact with the tissue 74. In other embodiments, for example... Figure 3 The external shape of the contact component can be planar.

[0173] In this specific embodiment, pulse frequencies ranging from several hertz to several kilohertz (e.g., up to 5 megahertz, MHz) can be used. Since fatigue events generated by multiple pulses or shock waves accumulate primarily at higher pulse frequencies, a large number of rapidly successive medium-power shock waves can be used instead of several higher-power shock waves separated by long pauses, significantly reducing processing time. As mentioned above, at least some of these specific embodiments (e.g., those with multiple spark gaps) allow for the generation of electro-hydraulic shock waves at higher frequencies. For example, Figure 5A A timing diagram 500 is depicted, enlarged to show the sequence of two voltage pulses 504, 508 applied to the electrodes of this specific embodiment and a delay period 512 between the voltage pulses 504, 508, and Figure 5B A timing diagram 516 is depicted, showing a large number of voltage pulses applied to the electrodes of this specific embodiment.

[0174] In an additional embodiment similar to spark head 22a, a portion of each sidewall may be omitted, such that each spark chamber is also omitted or remains open, allowing liquid in a larger chamber of the corresponding handpiece (e.g., chamber 18 or chamber 18a) to circulate freely between the electrodes. In such embodiments, the spark chamber (e.g., sidewall) may include a liquid connector, or the liquid may circulate through a plurality of liquid ports separate from the spark chamber (e.g., ...). Figure 4 (Depicted in Chinese).

[0175] The series of events (sparks) triggered by the plurality of bursts or groups 504 and 508 delivered by this system and device may include a higher pulse rate (PR), which can reduce processing time compared to a lower pulse rate that requires several minutes of application. The above-described embodiments can be used to deliver shock waves at the required pulse rate.

[0176] Figure 6 A free-form reflector is depicted. The free-form reflector can be designed using the spline interpolation process. In the specific embodiment shown, the final reflector shape can be modeled, for example, using a finite element method (FEM) simulation. The finite element method is a numerical technique used to find approximate solutions to boundary value problems. If the finite element method simulation determines that the free-form acoustic reflector is feasible, a physical prototype can then be fabricated and physically verified if necessary.

[0177] In the specific embodiment shown, once the reflector shape is defined, ray tracing is used to approximate the energy density reflected by the reflector. Traditionally, ray tracing refers to a technique that generates images by tracing the path of light and simulating the effect of light encountering a virtual object. Here, and as... Figure 6 The diagram depicts an energy density that can be approximated by ray tracing from the reflector shape defined by spline interpolation. Figure 6 In this system, sound waves 604 (described as vectors) are generated at the electrode gap 608 and reflected by a free-form reflector 606. Ideally, these sound waves possess a uniform pressure density upon reaching a target tissue depth 600 and dissipate by at least a factor of two before reaching a diffusion depth 602 (e.g., the treatment termination depth or the intended treatment termination depth). Figure 6 In the study, sound waves 604 are nearly evenly spaced at a target tissue depth of 600, exhibiting a nearly uniform energy distribution across the reflector profile. However, at a diffusion depth of 602, the rays are more widely separated, resulting in a lower energy density. While a uniform pressure density at the target tissue depth is ideal, peak pressure variations of 10%, 20%, or 30 percent higher or lower than other peak pressure readings from free-form reflectors can still achieve the desired therapeutic function without undesirable consequences.

[0178] Figure 6It also includes a dashed line depicting an intersecting or overlapping ray. Overlapping rays (or intersecting rays) are common in parabolic reflector designs. Since multiple waves can combine and exhibit constructive interference, i.e., an increase in magnitude, these rays symbolize an increase in peak pressure. However, in free-form acoustic reflector designs, i.e., those that are not parabolic or non-parabolic, these rays do not intersect. That is, the rays do not intersect before or after the diffusion depth 602. This is because free-form acoustic reflectors do not cause an increase in peak pressure at locations passing through the diffusion depth 602.

[0179] Figure 7 and Figure 8 A specific embodiment of one of the therapeutic wave generators is depicted. Figure 7 An isometric view depicting one of the spark head portions of the revealed therapeutic wave generator, including a free-form reflector 706. Furthermore, Figure 8 A cross-section of the spark head portion of one specific embodiment of a therapeutic wave generator is depicted, including a free-form reflector 706.

[0180] Figure 9 , Figure 10 and Figures 11A to 11C The diagram illustrates an example of an electro-hydraulic device for generating sound waves. Figure 9 This is a cross-sectional view depicting a specific embodiment of an electro-hydraulic device for generating sound waves, wherein the sound waves have a modified sound wavefront. For example... Figure 9 As shown, an electro-hydraulic device 1000 for generating sound waves includes: a housing 1004, a liquid, a sound wave reflector 1020, a plurality of electrodes 1016a, 1016b, and a pulse generation system. The housing 1004 defines a chamber 1008 and a shock wave outlet 1012. The liquid is disposed in the chamber 1008. The sound wave reflector 1020 is located within the chamber 1008. The plurality of electrodes 1016a, 1016b (e.g., in a spark head or module) are arranged within the chamber 1008 to define one or more spark gaps 708. The pulse generation system is configured to apply a plurality of voltage pulses to the electrodes 1016a, 1016b at a frequency between 10 Hz and 5 MHz. In the illustrated embodiment, the sound wave reflector 1020 may be a free-form reflector, while in other embodiments, the sound wave reflector may be parabolic.

[0181] In this specific embodiment, a stable acoustic wavefront is achieved using a free-form acoustic wave reflector having a spark gap formed by a plurality of electrodes, held at a constant focal location relative to the acoustic wave reflector.

[0182] In some specific embodiments, a spark gap between a plurality of (e.g., two) electrodes is automatically adjusted using a single servo motor 1024 to keep the spark gap located at a substantially constant focal position relative to one of the reflectors. For example, in Figure 9 , Figure 10 and Figures 11A to 11C In the specific embodiment shown, a single servo motor is used to move a pair of electrodes such that the size and location of the electrode gap remain substantially constant. Figure 9 A three-dimensional and cross-sectional view of a portion of a device or probe 1000 that can be connected to a power source to generate shock waves electro-hydraulically. Figure 10 A three-dimensional diagram depicts the probe 1000 assembly that allows the aforementioned electrode adjustments to maintain the size and location of the spark gap. Figures 11A to 11C Describe the three different locations Figure 10 The component is illustrated to show the maintenance of the spark gap.

[0183] In the illustrated embodiment, device 1000 includes a housing 1004 defining a chamber 1008 and a shock wave outlet 1012, the chamber being configured to receive (i.e., fill) a liquid such as water or saline. As shown, device 1000 also includes a plurality of electrodes 1016a, 1016b and an acoustic reflector 1020 disposed within the chamber 1008 (e.g., defining the boundary of the chamber). As shown, electrodes 1016 are arranged within the chamber 1008 to define one or more spark gaps 708 having a size (i.e., the distance between the end faces of electrodes 1016a and 1016b) and a location. In the illustrated embodiment, reflector 1020 is a freeform reflector.

[0184] In the illustrated embodiment, device 1000 includes a single servo motor 1024 mechanically connected to a plurality of electrodes 1016a, 1016b, and configured to adjust each electrode to substantially maintain the size and location of the spark gap 708 constant. In this embodiment, the servo motor 1024 has an output shaft 1028 with a chuck or connector 1032 connecting it to a lead screw 1036, which is threadedly connected to a shuttle or actuator 1040 such that rotation of the lead screw 1036 causes longitudinal movement of the actuator 1040. The main electrode 1016a is connected to the actuator 1040 (e.g., configured to be driven by the actuator 1040); for example, in the illustrated embodiment, a main electrode carrier 1044 extends / carries the main electrode 1016a and extends to the actuator 1040, as shown. In other specific embodiments, the electrode carrier 1044 and the main electrode 1016a may be a single unit (e.g., formed from a single material). As shown, a support rod 1048 is fixedly connected to the main electrode carrier 1044, and the support rod 1048 carries two actuator rods 1052a and 1052b. The actuator rods 1052a and 1052b extend from the support rod 1048 and are arranged to interact with two separate pivot arms 1056a and 1056b. As shown, the pivot arms 1056a and 1056b are pivotally connected (e.g., through a plurality of pins) to the housing 1004 at separate pivot points 1060a and 1060b, so that the actuator rods 1052a and 1052b are advanced in direction 1072.

[0185] In this specific embodiment, the secondary electrode 1016b is connected to (and carried by) the primary electrode carrier 1064. As shown, the secondary electrode carrier 1064 has an inverted U-shape and is slidably connected to the housing 1004 (e.g., slidably disposed in a groove or track 1068). Furthermore, a spring or other biasing member (not shown) biases the secondary electrode carrier 1064 and the secondary electrode 1016b away from the primary electrode 1016a in a direction 1072.

[0186] In this deployment, and as Figures 11A to 11C As shown in the progress diagram, when the motor 1024 is actuated, the shaft 1028 rotates the lead screw 1036, which then propels the shuttle 1040, main electrode carrier 1044, main electrode 1016a, support rod 1048, and actuator rods 1052a and 1052b longitudinally in the direction 1072. As these components advance, the actuator rods 1052a and 1052b contact and transmit a force in the direction 1072 to the respective first ends 1076a and 1076b of the pivot arms 1056a and 1056b. The upward (depending on) force on the first ends 1076a and 1076b... Figures 11A to 11C The force (as depicted in the diagram) causes the pivot arms 1056a and 1056b to pivot around their respective pivot points 1060a and 1060b, and moves the respective second ends 1080a and 1080b of the pivot arms downward to transmit a force to the secondary electrode carrier 1064 in direction 1084, thereby moving the secondary electrode 1016b toward the primary electrode 1016a. In this way, when the electrode corrodes during use, a single servo motor can simultaneously move the primary electrode 1016a upward and the secondary electrode 1016b downward to maintain the size and position of the electrode gap between the ends of electrodes 1016a and 1016b.

[0187] Since the primary electrode 1060a is the anode, it is consumed or degraded with each spark discharge, and this consumption or deterioration rate is faster than that of the secondary electrode 1060b, which is the cathode, at a specific rate. The lengths of the first ends 1076a and 1076b of the pivot arms 1056a and 1056b from the pivot points 1060a and 1060b, and the lengths of the second ends 1080a and 1080b of the pivot arms 1056a and 1056b from the pivot points 1060a and 1060b, can be designed such that when the motor 1024 moves one step to move the primary electrode 1060a a fixed distance upwards in direction 1072, the pivot... The difference in length of the shaft arms 1056a and 1056b from the pivot points 1060a and 1060b will cause the second ends 1080a and 1080b to push the secondary electrode carrier 1064 to move the secondary electrode 1016b downward in the direction 1084, thereby maintaining the gap 708 at a suitable length and at the focal point of the reflector 1020.

[0188] In the illustrated embodiment, device 1000 also includes a circuit board assembly 1100, as described in U.S. Provisional Patent Application No. 62 / 365,009 (incorporated above), which is configured to receive voltage from an external pulse generation system (not shown) and deliver voltage pulses to and / or through the main electrode 1016a to generate a spark between the electrodes and thus generate a shock wave. In the illustrated embodiment, a controller 1104 is electrically connected to one or both of the electrodes via connector 1108 (e.g., via circuit board assembly 1100 as shown, or directly in other embodiments) and electrically connected to motor 1024 via connector 1112, such that the controller can control motor 1024 based on the measurement of the spark between the electrodes. For example, to maintain a constant electrode gap size and position, a closed-loop control is used to signal motor 1024 to feed the electrodes forward and maintain the spark gap 708 at the required size. Closed-loop control can be implemented by measuring the discharge pulse time at a specific charging voltage. The characteristics of the discharge are closely related to the distance of the spark gap 708 (e.g., the electrode gap). By measuring these characteristics, closed-loop control can be implemented by sending a signal to the motor 1024 to move and thereby maintain the gap between the electrodes, and then maintain the electrical characteristics required for the discharge.

[0189] In some embodiments, controller 1104 is a component of the spark generation system (e.g., the functions described for controller 1104 are instructions or codes executed by the main discharge controller of the spark generation system). For example, motor 1024 can be directly driven by the main discharge controller of the spark generation system by applying electrical pulses directly to the motor windings via extended leads. In other embodiments, controller 1104 is a second and / or independent controller with separate adjustment functions. For example, controller 1104 may be mounted in a housing and may receive analog or digital signals (e.g., electrical, optical, and / or similar) from one of the spark generation systems or the main controller.

[0190] The electro-hydraulic shockwave generator disclosed herein produces an acoustic wavefront with improved acoustic wavefront uniformity. According to one embodiment, the improved acoustic wavefront uniformity is achieved by using an electro-hydraulic generator employing a free-form acoustic reflector and a single servo motor electrode adjustment system. As a result, when the electro-hydraulic device disclosed herein is used to treat a patient, it provides more consistent and comfortable acoustic shockwave therapy.

[0191] Figure 12 The diagram illustrates an example of a vacuum system, such as... Figure 1 Vacuum system 112. Figure 12A distributed vacuum system 1200 is depicted, comprising a controller 1210 (e.g., a control unit) and a vacuum head 1212 (e.g., a distal head) capable of assisting in the application of one or more types of treatments. Figure 12 In this configuration, the vacuum head 1212 is separate from the controller 1210 and is connected to the controller via a flexible tube or conduit called an umbilical cord 1214.

[0192] The controller 1210 (e.g., a control unit) includes a controller 1220 (e.g., control logic, circuit board, processor and memory, field-programmable gate array, etc.), a motor 1222 (e.g., a servo mechanism or servo motor), a valve 1224 (e.g., a butterfly valve), and an indicator 1226. Figure 12 As illustrated, controller 1210 is connected to a power source 1216 (e.g., via cable 1218). In other implementations, controller 1220 is battery powered and includes a battery or other power source. Controller 1220 is configured to control motor 1222 or operate valve 1224, for example, to control or adjust the position of valve 1224. Furthermore, controller 1220 is configured to control indicator 1226 to indicate the position of valve 1224. Additionally, controller 1220 is configured to control the delivery of negative pressure and / or cooling air 1240 to vacuum head 1212.

[0193] Cooling air 1240 may be used for certain procedures only. For example, cooling air may be suitable for laser-induced optical breakdown (LIOB) therapy when a laser or electromagnetic wave / radiation is radiated onto a treatment area. Cooling air 1240 may not be used in conjunction with sonic subcutaneous ablation therapy or treatment, for example, it may provide little or no benefit to sonic subcutaneous ablation therapy or treatment. However, incorporating cooling air components and functions into vacuum system 1200 allows a single vacuum system (e.g., a single vacuum system 1200, such as its controller 1210 and / or vacuum head 1212) to be used for sonic subcutaneous ablation procedures and other procedures (e.g., laser-induced optical breakdown procedures, such as tattoo removal).

[0194] The vacuum head 1212 includes one or more lamps 1230 and one or more sensors 1232. For example... Figure 12As illustrated, the vacuum head 1212 includes one or more light-emitting diodes (LEDs) and one or more infrared sensors. In some implementations, the LEDs are arranged to provide light to the substrate and / or window of the vacuum head to illuminate the processing area. Alternatively, the vacuum head 1212 is arranged to provide an indication via one or more LEDs. For example, the vacuum head 1212 may be arranged to provide an indication of the vacuum status. For illustration, the vacuum head 1212 may indicate an operating status (e.g., achieving and / or maintaining negative pressure or vacuum), vacuum release (e.g., loss of vacuum or negative pressure), or both via one or more LEDs. The umbilical cord 1214 may include one or more lumens, such as one or more dedicated lumens for providing negative pressure, cooling air, return air, etc.

[0195] In other implementations, controller 1210 may include a power switch (e.g., power switch 1302) configured to activate and / or apply negative pressure. For example, controller 1210 may not include one or more controllers 1220, motor 1222, valve 1224, or indicator 1226. For illustration, controller 1210 may include or correspond to a control system for a pump (e.g., controlling the pump's activation or on / off state). Alternatively, controller 1210 may include one or more of controllers 1220, motor 1222, valve 1224, or indicator 1226, but in such implementations, one or more of controllers 1220, motor 1222, valve 1224, or indicator 1226, or a combination thereof, corresponds to vacuum or negative pressure. For clarity, valve 1224 may be configured to control the application of negative pressure in response to motor 1222 controlled by controller 1220, and indicator 1226 may indicate vacuum pressure or valve 1224 position. In such implementations that omit cooling air components and / or functions, vacuum head 1212 may include, for example, a vacuum port and may not include a second or cooling air port. Alternatively, umbilical cord 1214 may include a single lumen (e.g., a negative pressure lumen).

[0196] Figure 13 A perspective view 1300 illustrates an example of a controller 1210 (e.g., a control unit). Figure 13 As shown in the figure, the controller 1210 includes a power switch 1302, a power input port or socket 1304 configured as a receiving plug, a wiring port 1306, an air port (e.g., an output cooling air output port, a vacuum port, or both) 1308, an output tube or conduit 1310, and an indicator light 1312.

[0197] Figure 14 This diagram illustrates a three-dimensional semi-transparent view of an example controller 1210 (e.g., a control unit), showing an example arrangement of the internal components of the controller 1210. Figure 14 As illustrated in the figure, controller 1210 includes a butterfly valve 1402, which is connected to a servo motor 1404 via a flexible shaft 1406. Controller 1210 further includes a plurality of rubber feet 1408. An illustrated arrangement of other components of controller 1210 is also depicted in... Figure 14 middle.

[0198] Figure 15 A perspective view 1500 illustrates an example of a vacuum head 1212 (e.g., a distal head). The vacuum head 1212 includes one or more ports. Figure 15 As illustrated, vacuum head 1212 includes a cooling air inlet port 1502, a vacuum pressure inlet port 1504, and a vacuum release switch 1506. In other implementations, vacuum head 1212 does not include cooling air inlet port 1502, for example when vacuum head 1212 is not used to provide laser-induced photoluminescence disintegration therapy. In some implementations, vacuum head 1212 further includes one or more lamps (e.g., lamp 1230, such as light-emitting diodes).

[0199] Vacuum head 1212 is configured to assist in selectively delivering acoustic subcutaneous cutting to a target area in the biological medium. As shown in the figure, vacuum head 1212 is configured for use in conjunction with an acoustic subcutaneous cutting device, such as one of the plurality of acoustic subcutaneous cutting devices described herein, some of which may be located within the vacuum head, at one end of vacuum head 1212 (or... Figure 14 The lower end of the vacuum head 1212 is positioned to press against a biological medium (e.g., tissue 192 or skin). For example, the housing of the vacuum head 1212 may include a polymer or other material. As shown, the housing of the vacuum head 1212 defines one or more internal channels and one or more openings (e.g., an annular opening), through which the vacuum system is connected (e.g., continuously around the periphery of a treatment area or at multiple points) to apply suction to the skin or other biological medium. As used by the user in this case, the term "vacuum" refers to a pressure below ambient atmospheric pressure (e.g., negative pressure), not the complete absence of matter.

[0200] In some implementations, the vacuum head 1212 includes a window (e.g., a transparent window) that allows shock waves to pass through the vacuum head 1212, assists in cooling the skin or other biological media (e.g., by providing a heat dissipation device to extract heat from the skin or by providing cooling air), and / or assists in stabilizing the skin or other biological media (e.g., by creating an enclosing space in which a vacuum or suction force can be applied to the skin). In some specific embodiments, the window may include a sapphire material that can be cooled, for example, before contact with the biological media (e.g., skin).

[0201] In some such implementations, the vacuum head 1212 isolates a segment of the biological medium by pulling a portion of the biological medium into contact with a window. This stabilizes that portion of the biological medium for processing. Figure 15 As shown in the illustration, in this specific embodiment, the housing of the vacuum head 1212 includes a plurality of external connectors (e.g., ports 1502, 1504), through which the vacuum source can be connected to a plurality of internal channels to communicate with the processing area.

[0202] In other embodiments, the vacuum head 1212 also includes a thermometer (e.g., an infrared or other non-contact thermometer) connected to the housing and oriented to monitor the temperature of skin or other biological media. Other embodiments may omit the window in favor of an uncovered hole or opening, omit a thermometer, and / or omit a light source (e.g., a light-emitting diode).

[0203] Figures 16A to 16E The figure shows an additional view of an example vacuum head (e.g., a remote head) of a vacuum system such as vacuum system 112 or 1200. Figure 16A The illustration shows a three-dimensional view of an example of vacuum head 1612. Figure 16B The diagram shows Figure 16A A side sectional view of the vacuum head 1612. Please refer to... Figure 16A The diagram illustrates a sample layout of a plurality of lamps 1632A and 1632B and a plurality of sensors 1634. Figure 16A The vacuum head includes multiple indicator lights 1632A (e.g., white LEDs), illumination lights 1632B (e.g., red, green, and blue LEDs), and sensors 1634, such as temperature sensors, pressure sensors, or a combination of both (e.g., below the green circuit board). Figure 16 also illustrates the layout of the lights 1632A, 1632B, and sensor 1634, and further illustrates a flange 1622 connected to the bottom or base of the body or housing of the vacuum head 1612. Figure 16A and Figure 16B As illustrated, the flange 1622 (e.g., a compliant component) is arranged to form a seal with a processing area, which can generate and maintain a vacuum or negative pressure by means of the vacuum head 1612.

[0204] Figure 16C and Figure 16D The diagram shows Figure 16A and Figure 16B Additional view of flange 1622 of vacuum head 1612. Please refer to... Figure 16C The figure shows a three-dimensional view of flange 1622. Figure 16D The diagram shows Figure 16C A side cross-sectional view of flange 1622. In some implementations, flange 1622 is made of or contains a photopolymer.

[0205] Figure 16E The figure shows a side cross-sectional view of a vacuum head 1652. Relative to vacuum head 1612, vacuum head 1652 includes an outer mold flange 1624 and a compact or low-profile substrate (e.g., a housing or body). Flange 1624 actuates similarly to flange 1622. In some implementations, Figures 16A to 16E The flanges 1622 and 1624 shown in the diagram have a Shore A hardness of 30 to 50. Flanges 1622 and 1624 can be configured to operate at approximately 5 inches of mercury (in Hg) and approximately 24 inches of mercury at atmospheric pressure. Although Figure 16E No lamp or sensor is shown in the figure, but in other implementations, vacuum head 1652 includes a lamp (e.g., lamp 1632A, lamp 1632B or both), a sensor (e.g., sensor 1634), or a combination thereof.

[0206] Figure 17A and Figure 17B The diagram shows a view of an example of an integrated vacuum system. Figure 17A A perspective view 1700 illustrates an example of an integrated vacuum system 1712 (e.g., an integrated head). An integrated system refers to a controller or control unit (e.g., one or more of its components) being contained within a housing (also referred to as a vacuum head housing), which also contains or defines the aforementioned vacuum head. The integrated vacuum system 1712 includes a housing or substrate that defines one or more ports. Similar to other vacuum systems, the integrated vacuum system 1712 is also connected to a power source, a cooling air source, and / or a vacuum source. Figure 17A As illustrated, the integrated vacuum system 1712 includes a plurality of light-emitting diodes and a plurality of sensors. In other implementations, the integrated vacuum system 1712 may omit the lamps (e.g., light-emitting diodes), sensors, or both.

[0207] Figure 17B The diagram shows Figure 17A The side sectional view 1750 of the vacuum head 1212 (e.g., a distal head) example shown in the figure. Figure 17B The diagram illustrates a plurality of through channels defined by the integrated vacuum system 1712, with the through channels and Figure 17A One or more ports are shown in the diagram. Furthermore, Figure 15 The internal channels, annular rings, and windows / openings shown in the diagram are illustrated in [the diagram]. Figure 17B In the vacuum head 1212 of the integrated vacuum system 1712.

[0208] Figure 18The figure illustrates a method 1800 for treating a patient to improve the appearance of cellulite using an acoustic subcutaneous cutting device. Method 1800 can be performed using or via system 100 (e.g., device 110 of system 100), system 600, etc. Method 1800 includes positioning the acoustic subcutaneous cutting device adjacent to a treatment site, i.e., operation 1810. For example, the acoustic subcutaneous cutting device may include or correspond to acoustic subcutaneous cutting device 110, probe 38, probe 38a, system 600, device 1000, and the treatment site may include or correspond to a treatment area, tissue site 150, a treatment location within a treatment area, tissue 74, or tissue 192.

[0209] Method 1800 further includes applying a shock wave to the treatment site, i.e., operation 1812. For example, the shock wave may include or correspond to a shock wave pulse, such as a rapid acoustic pulse (RAP). For illustration, one of the aforementioned acoustic subcutaneous cutting devices generates... Figure 1 Shockwave pulse 132 or Figure 2A Pulse 200.

[0210] In some implementations, method 1800 further includes applying a plurality of shock waves to the processing site, wherein the plurality of shock waves are applied at a pulse repetition frequency between 10 Hz and 200 Hz, between 50 Hz and 100 Hz, between 20 Hz and 500 Hz, or between 10 Hz and 1000 Hz.

[0211] In some implementations, method 1800 further includes applying a plurality of shock waves to the processing site at discrete time intervals, wherein the time intervals have a duration of 1 to 3 minutes and correspond to a specific processing area within the processing site.

[0212] In some implementations, method 1800 further includes positioning a vacuum head on the treatment site; applying the vacuum head to the treatment site; and generating a negative pressure. For example, the vacuum head may include or correspond to vacuum system 112, vacuum system 1200, vacuum head 1212, or integrated vacuum system 1712. For illustration, a vacuum head 1212 is attached to tissue 192 of tissue site 150. In a particular implementation, method 1800 further includes applying cooling air to the treatment site, as referenced... Figure 15 Explanation.

[0213] Therefore, Method 1800 describes a method for treating a patient using an acoustic subcutaneous cutting device to improve the appearance of cellulite. The acoustic subcutaneous cutting device enables the treatment and medical procedures to create a physical effect within the tissue, causing the fibrous septum in the subcutaneous fat to break down. Compared to current subcutaneous cutting devices and techniques, Method 1800 is non-invasive, thereby increasing applicability and reducing complications and patient discomfort. Consequently, the acoustic subcutaneous cutting device and method described herein can improve the treatment of adipose tissue defects, thereby increasing patient comfort and confidence during the procedure.

[0214] Figure 19 The figure illustrates a method 1900 for treating a patient to improve the appearance of cellulite by using a plurality of rapid sonic pulses to cause disruption of fibrous structures (dermis and / or subcutaneous tissue). Method 1900 can be performed by a patient or healthcare professional using one or more components of system 100 or system 600. Method 1900 includes identifying a treatment site containing cellulite, i.e., operation 1910. For example, the treatment site may include or correspond to a treatment area, a tissue site 150, a treatment location within the treatment area, tissue 74, or tissue 192. For illustration, the patient or healthcare professional (e.g., a technician, nurse, physician, etc.) identifies a treatment site or area containing or corresponding to cellulite. In some implementations, method 1900 further includes identifying a plurality of treatment locations within a treatment site or area.

[0215] Method 1900 also includes applying a series of shockwave pulses to the treatment site, i.e., operation 1912. For example, the shockwave may include or correspond to a single shockwave pulse, such as a rapid acoustic pulse (RAP). For illustration, an acoustic subcutaneous cutting device (e.g., acoustic subcutaneous cutting device 110, probe 38, probe 38a, system 600, device 1000) applies pulses 132 or 200 as described herein, for example, referring to... Figure 5A and Figure 5B Explanation.

[0216] In some implementations, method 1900 further includes applying a plurality of shock waves to the processing site, wherein the plurality of shock waves are applied at a pulse repetition frequency between 10 Hz and 200 Hz, between 50 Hz and 100 Hz, between 20 Hz and 500 Hz, or between 10 Hz and 1000 Hz.

[0217] In some implementations, method 1900 further includes applying a plurality of shock waves to the processing site at discrete time intervals, wherein the time intervals have a duration of 1 to 3 minutes and correspond to a specific processing area within the processing site.

[0218] In some implementations, method 1900 further includes positioning a vacuum head on the treatment site; applying the vacuum head to the treatment site; and generating a negative pressure. For example, the vacuum head may include or correspond to vacuum system 112, vacuum system 1200, vacuum head 1212, or integrated vacuum system 1712. For illustration, a vacuum head 1212 is attached to tissue 192 of tissue site 150. In a particular implementation, method 1900 further includes applying cooling air to the treatment site, as referenced... Figure 15 Explanation.

[0219] Therefore, Method 1900 treats a patient to improve the appearance of cellulite by using multiple rapid sonic pulses to cause the dermal and / or subcutaneous fibrous structures to break up. The rapid sonic pulses (e.g., the peak pressure, rise and fall time, and repetition frequency of a rapid sonic pulse) enable the treatment and medical procedures to create physical effects in the tissue, causing the rupture of fibrous diaphragms in the subcutaneous fat. Compared to current subcutaneous cutting devices and techniques, Method 1900 is non-invasive, thereby increasing applicability and reducing complications and patient discomfort. Compared to current pressure wave techniques or invasive techniques, Method 1900 targets previously untreatable cellulite (e.g., high-grade or grade 2 and above cellulite) and other fibrous tissue formation states, and for such targets, it uses targeted treatment periods with increased peak pressure, rise and fall time, and repetition frequency to induce cumulative vibration / stress that will cause physical effects (e.g., rupture of hardened diaphragms). Therefore, the ultrasonic subcutaneous cutting device and method described in this article can improve the treatment of adipose tissue defects, thereby enhancing patient comfort and confidence during the procedure.

[0220] Although method 1800 describes the treatment of a fibrous diaphragm, other implementations may treat other types of tissue, such as skin, adipose tissue, muscle tissue, organ tissue (e.g., reproductive organ tissue and / or its corresponding skin tissue). Furthermore, although method 1900 describes the treatment site as containing cellulite, other implementations may treat sites containing, or alternatively to, cellulite, such as a scar, a hypertrophic scar, or a cystic implant. In some such implementations, compressed, non-cavitation fast acoustic pulses (e.g., pulses 200, 280, 295), such as unfocused or planar shock waves with a negative pulse component duration of less than 2 microseconds, may be used.

[0221] Please refer to Figures 20A to 22B The image shows representative histologic slides depicting fibrous diaphragms in subcutaneous fat and ruptured fibrous diaphragms after treatment. Figure 20A , Figure 21A and Figure 22A The illustration shows a representative histological slide depicting the fibrous diaphragm of Göttingen Minipigs. This type of fibrous diaphragm is representative of human fibrous diaphragms, corresponding to cellulite, scars, dermal ridges, etc. Figure 20B , Figure 21B and Figure 22B The illustration shows a representative histological slide depicting a fibrous diaphragm after subcutaneous ultrasound dissection.

[0222] Please refer to Figure 23A and Figure 23B The image shows before and after photos of a representative human patient undergoing treatment. Figure 23AThe image shown is an image of the dermal ridges of orange peel tissue on a patient's thigh before treatment. Figure 23B The diagram shows Figure 23A Images of the dermal ridges of orange peel tissue 12 weeks after treatment.

[0223] Please refer to Figures 24A to 30B The image shows a representative glass slide depicting a broken, post-treatment treated fibrous septum, as well as tissue responses such as angiogenesis and collagen regeneration. Figures 20A to 30B Further explanation is provided in the section on experimental results.

[0224] Experimental results

[0225] Experiments were conducted to verify the acoustic subcutaneous cutting device of the present invention.

[0226] Example 1: Ultrasonic subcutaneous dissection of subcutaneous fibrous diaphragm

[0227] A study was conducted using Göttingen miniature pigs weighing approximately 30 kg to evaluate the disruption of fibroblast extracellular matrix in subcutaneous fat using a sonic subcutaneous cutting device. This device produces sonic pulses with a high (approximately 10 million Pascals, relative to the second study described below in Example 2) average peak output pressure (i.e., the average peak output pressure of each pulse). The sonic subcutaneous cutting device generates unfocused, non-cavitating, rapid sonic pulses (RAPs). Such unfocused, non-cavitating, rapid sonic pulses (RAPs) may include or correspond to pulses 200, 280, and 295.

[0228] The general procedure involves anesthetizing the animal and preparing the mid-abdomen by removing the skin and hair using a clipper followed by a razor. A sonic subcutaneous cutting device is then used to deliver high-frequency shockwaves to the treatment site, each wave having a peak output pressure of approximately 10 million Pascals at a pulse repetition frequency of 50 Hz over two minutes.

[0229] After high-frequency shock wave treatment, a biopsy was obtained from the treated site using a 3 mm circumferential forceps. The treated tissue sample was placed in a buffered formalin solution. Tissue slides were then prepared from the treated tissue sample and stained with hematoxylin and eosin (H&E) for microscopic examination. A tissue slide prepared from an untreated tissue sample was used as a control sample.

[0230] Figure 20A and Figure 20B Provides histological images at 2x magnification, showing fibrous septa in the subcutaneous tissue. Figure 20A The diagram shows the fibrous diaphragm in the untreated area, and Figure 20BThe diagram illustrates the fibrous diaphragm at the treated site. (For example, it can be made from...) Figure 20A and Figure 20B Histological images show that, compared to Figure 20A Fiber diaphragm in untreated areas Figure 20B The fibrous diaphragm in the treated area was found to be largely broken. Figure 20B The figure also shows no evidence of cavitation or thermal damage in the tissue from the treated site. Furthermore, the blood vessels remain intact and undamaged, with no evidence of any gross hematoma.

[0231] Figure 21A and Figure 21B Provides histological images from different tissue samples at 20x magnification, showing fibrous septa in subcutaneous tissue. Figure 21A The diagram shows the fibrous diaphragm in the untreated area, and Figure 21B The diagram illustrates the fibrous diaphragm at the treated site. Again, as can be achieved by... Figure 20A and Figure 20B Histological images show that, compared to Figure 21A Fiber diaphragm in untreated areas Figure 21B The fibrous diaphragm in the treated area was found to be highly fragmented. Figure 21B The figure also shows no evidence of cavitation or thermal damage in the tissue from the treated site. The results of this study support the ability of the rapid sonic pulses of this invention to cause subcutaneous sonic slicing of the subcutaneous fibrous diaphragm.

[0232] II. Example 2: Ultrasonic subcutaneous incision of subcutaneous fibrous diaphragm

[0233] Another study was conducted using Göttingen miniature pigs to evaluate the disruption of fibrous diaphragms in subcutaneous fat using a sonic subcutaneous cutting device that produces sonic pulses with a mid-range (approximately 6 million Pascals) peak output pressure. The same general procedure outlined in Example 1 was followed. However, the sonic subcutaneous cutting device was then used to deliver high-frequency shockwaves at the treatment site, each wave having an average peak output pressure of approximately 6 million Pascals over three minutes at a pulse repetition frequency of 100 Hz.

[0234] Figure 22A and Figure 22B Provides histological images at 20x magnification, showing fibrous septa in the subcutaneous tissue. Figure 22A The diagram shows the fibrous diaphragm in the untreated area, and Figure 22B The diagram illustrates a fibrous diaphragm at a treated site. (The image likely shows a fibrous diaphragm.) Figure 22A and Figure 22B Histological images show that, compared to Figure 22A extracellular matrix of fibroblasts in untreated areas Figure 22BThe extracellular matrix of the fibroblasts in the treated area showed significant fragmentation. Figure 22B The figure also shows no evidence of cavitation or thermal damage in the tissue from the treated site. The results of this study further support the ability of rapid sonic pulses to induce sonic subcutaneous slicing of subcutaneous fibrous structures. The results of this study also support the ability to safely induce tissue fragmentation via rapid sonic pulses for subcutaneous slicing.

[0235] Experiments were conducted on humans to observe the effects of subcutaneous cutting with shockwaves on the corresponding subcutaneous fat containing cellulite tissue (such as fibrous subcutaneous diaphragm).

[0236] III. Example 3: Pilot Research

[0237] An Institutional Review Board (IRB) has approved the commencement of human clinical trials to examine the efficacy of the acoustic subcutaneous cutting device of this invention in improving the appearance of cellulite pits or ridges caused by sclerotic fibrous diaphragms. The objective of this pilot study is to demonstrate that the application of the non-invasive acoustic subcutaneous cutting device (ASD) is completely tolerable to patients and results in an improvement in the appearance of cellulite, as measured by a reduction in the mean simplified cellulite severity score (CSS).

[0238] Women with grade 2 cellulite and a body mass index (BMI) of less than 30 were eligible for enrollment. Each participant underwent treatment in a randomly selected area of ​​the upper thigh (approximately 25 cm x 25 cm) within a single session. A sonic subcutaneous cutting device was applied 20 times per minute at 20 treatment sites within the area, resulting in a total treatment time of 20 minutes per patient per single visit. Each of the 20 treatment sites received one one-minute application. Each high-frequency shockwave application had a mean peak output pressure of approximately 6 million Pascals at a pulse repetition frequency of 50 Hz. Histological evidence from animal studies has shown that these rapid sonic pulses break down collagen fibers throughout the adipose septum, effectively leading to septal fragmentation and possible subcutaneous cutting. Standardized photographs were taken before treatment and 12 weeks later. These before / after photographs were paired and evaluated by three blinded reviewers, who were asked to identify which photograph was taken after treatment and to assign a cellulite severity score from 0 to 5 points to both photographs. After treatment, adverse events and pain were recorded using a 0 to 10-point scale, where 0 indicates no pain and 10 indicates the most severe pain.

[0239] Five women aged 30 to 54 years enrolled in this study. Only mild folliculitis at the treatment site, which resolved within hours, was reported; erythema, edema, or contusions were not described. 97% of the treatment sites experienced pain at a level rated "0" (no pain) on a 0-10 scale. The highest score was 4 at one treatment site for one participant, which resolved when the ultrasonic subcutaneous cutting device was applied directly to the greater trochanter of the femur and when the device was repositioned laterally at the trochanter. Blinded evaluation by three reviewers showed a decrease in the mean cellulite severity score from 4.27 to 3.03 (p<0.001), and 100% correct identification of post-treatment photographs was achieved through pre / post-treatment pairing.

[0240] The results of this pilot study show that a single treatment with a non-invasive, near-painless sonic subcutaneous cutting device resulted in a significant improvement in the appearance of cellulite tissue with no downtime for the patient.

[0241] IV. Example 4: Treatment of Orange Peel Tissue – Case Report

[0242] This case report is taken from the study illustrated in Example 3 above.

[0243] One particular patient in this study presented with severe cellulite characterized by a deep dermal ridge. This type of deep dermal ridge is typically treated using a surgical procedure, such as an invasive subcutaneous incision (i.e., a special subcutaneous needle is inserted through a perforation in the skin to sever the diaphragm within the subcutaneous fat). In this study, the cellulite in this particular patient, including the deep dermal ridge, was treated according to the procedure outlined above. Figure 23A and Figure 23B The figure shows the moment before the processing of a fast acoustic pulse. Figure 23A ) and 12 weeks after rapid acoustic pulse treatment ( Figure 23B (Photo of the image). If available... Figure 23A and Figure 23B The results showed significant improvement in deep dermal ridges in the patient's thigh at the 12-week time point after rapid sonic pulse treatment. The patient's before and after cellulite photographs were assessed by three independent physician reviewers using the Cellulite Severity Scale (Kaminer et al., 2015). At 12 weeks, the patient's cellulite, including dermal ridges, showed a significant reduction of 1.5 points (from 4.83 before to 3.33 after). Rapid sonic pulse treatment, using a single treatment with a sonic subcutaneous cutting device, provided significant elimination of cellulite ridges in the patient without any pain, bruising, swelling, or downtime.

[0244] The above description and examples provide an illustration of the process and use of a specific embodiment. Although some specific embodiments have been described above by way of a particular degree of specificity or by reference to one or more individual embodiments, those skilled in the art can make numerous changes to the disclosed embodiments without departing from the scope of the invention. Thus, the illustrative embodiments of this method are not intended to limit oneself to the specific steps disclosed. Rather, the embodiments include all modifications and changes falling within the scope of the claims, and embodiments other than those shown may include some or all of the features of the depicted embodiments. Furthermore, when appropriate, the concept of any of the above examples can be combined with the concept of any other example described to form further examples with comparable or different characteristics and addressing the same or different problems. Similarly, it will be understood that the above benefits and advantages may relate to one embodiment or several embodiments.

[0245] V. Example 5: Inducing a tissue response using rapid acoustic pulses

[0246] A study was conducted using Göttingen miniature pigs weighing approximately 30 kg to evaluate the induction of a tissue response (e.g., angiogenesis) by physically disrupting tissue structure using (non-cavitation) compressed rapid sonic pulses such as pulses 200, 280, and 295. The same general procedure outlined in Example 1 was followed. However, the rapid sonic pulses had an average peak output pressure of 8 to 9 megapascals within two minutes at a frequency of 50 Hz. In addition, the rapid sonic pulses had a negative pulse component duration of less than 2 microseconds.

[0247] Figures 24A to 26 Histological images are provided, showing tissue fragmentation (e.g., fibrous septum) in the subcutaneous tissue at different time points after treatment. Please refer to [reference needed]. Figure 24A , Figure 24A A histological image at 5x magnification shows tissue fragmentation (e.g., fibrous diaphragm) in the subcutaneous tissue immediately after treatment. Figure 24B Tie Figure 24A A magnified histological image of a part of the histological image shows in more detail the tissue (such as fibrous diaphragm) in the subcutaneous tissue immediately after treatment.

[0248] Figure 25A and Figure 25B Provides histological images at 5x magnification, comparing tissue immediately after processing. Figure 25A Similar to Figure 24A ) and tissue 6 days after treatment ( Figure 25B ).like Figure 25B As shown, tissues treated 6 days prior have demonstrated superiority compared to... Figure 25A The tissue shown exhibits significant tissue responses (e.g., angiogenesis).

[0249] Figure 26 supply Figure 25B The image shows a detailed histological image of a tissue sample taken 6 days after treatment. Figure 26 Includes a histological image of 2600, similar to Figure 25B 10x magnification of tissue samples 6 days after treatment. Figure 26 It also includes two further magnified sections, 2610 and 2620, illustrating the dermis and subcutaneous tissue. The dermis shown in magnified section 2610 and the subcutaneous tissue shown in magnified section 2620 both demonstrate a significant tissue reaction following the deposition of new collagen and the distribution of new blood vessels, resulting in a thicker fibrous septum. As can be seen from the close-up histological images (magnified sections 2610 and 2620), both adipocytes and the fibrous septum are fragmented. There is no evidence of cavitation or thermal damage in the tissue.

[0250] The results of this study support the ability of the sonic subcutaneous cutting device to safely cause tissue disruption with rapid sonic pulses, thereby inducing a tissue response by generating new collagen and new blood vessels in the dermis and subcutaneous adipose tissue.

[0251] VI. Example 6: Inducing a tissue response using rapid acoustic pulses

[0252] Another study was conducted using Göttingen miniature pigs to evaluate the induction of tissue responses (e.g., angiogenesis) through the physiological disruption of tissue structure using (non-cavitation) compressed rapid sonic pulses such as pulses 200, 280, and 295. The same general procedures outlined in Example 1 were followed. However, similar to Example 5, the rapid sonic pulses had an average peak output pressure of approximately 8 to 9 megapascals, a negative pulse component duration of less than 2 microseconds, and were delivered within two minutes at a frequency of 50 Hz.

[0253] Figure 27A and Figure 27B Provides histological images at 5x magnification, showing tissue fragmentation (e.g., fibroblastic extracellular matrix) in the subcutaneous tissue immediately after treatment. Figure 27A ), to tissue from the same treatment site 6 days post-treatment ( Figure 27B Six days post-treatment tissue evidence showed a significant tissue reaction beginning with collagen deposition and new blood vessel distribution, manifested as a thicker fibrous diaphragm. There was no evidence of cavitation or thermal damage in the tissue.

[0254] Figure 28A and Figure 28B Provided from the day of processing ( Figure 28A ) and 6 days after treatment ( Figure 28B Close-up histological images of muscle tissue. Six days after treatment, the muscle tissue showed a significant tissue response with increased angiogenesis.

[0255] The results of this study support the ability of the sonic subcutaneous cutting device to safely cause tissue disruption with rapid sonic pulses, thereby inducing a tissue response by generating new collagen and new blood vessels in the dermis, subcutaneous adipose tissue, and muscle tissue.

[0256] VII. Example 7: Inducing a tissue response in humans using rapid sound wave pulses

[0257] In another study, a middle-aged female participant undergoing abdominoplasty was treated with sonic subcutaneous incision to assess the physiological disruption of the extracellular matrix structure of the dermis induced by rapid sonic pulses. Treatment and control sites were demarcated and marked with a pen. Despite the absence of anesthesia, a sonic subcutaneous incision device delivered rapid sonic pulses to the treatment site. The rapid sonic pulses delivered by the sonic subcutaneous incision device had a mean peak output pressure of approximately 4 to 6 million Pascals and were delivered at a frequency of 50 Hz per 10 square centimeters over approximately 2 minutes. In addition, the rapid sonic pulses had a negative pulse component duration of less than 2 microseconds. Participants reported no discomfort during the application of the rapid sonic pulses.

[0258] Four days after treatment, participants underwent abdominoplasty at the control site. Following the surgical procedure, biopsies were prepared from the treated and control sites using 3 mm circumferential forceps. Tissue samples were placed in buffered formalin. Histological slides of the tissue samples were stained with hematoxylin and eosin for microscopic examination.

[0259] Figure 29A and Figure 29B Provide control points ( Figure 29A ) and treatment area ( Figure 29B Histological images of tissue at 10x magnification 4 days after treatment. As can be seen, compared to Figure 29A The central control area Figure 29B The treated area showed significant tissue fragmentation. There was no evidence of cavitation or thermal damage in the treated tissue. Figure 29B ).

[0260] In similar animal studies, fragmented dermal tissue induced a tissue response, evidenced by an increase in new collagen (collagen regeneration) 62 days after treatment. Figure 30A (Day 0) and Figure 30B As shown on (Day 62). Figure 30A and Figure 30B The slide shown is at 8x magnification, and the image shows new collagen (which appears blue when stained) that has developed for 62 days after treatment.

[0261] The results of this study further support the ability of unfocused, non-cavitating, rapid pulsed sonic shockwaves to safely cause fragmentation within tissue (i.e., the dermis) structures without evidence of cavitation or thermal damage. Furthermore, the fragmented tissue induces tissue responses such as those demonstrated by increased new collagen production in the dermis.

[0262] The results of the studies in Examples 5 to 7 support the ability of the sonic subcutaneous cutting device to safely cause tissue disruption with rapid sonic pulses, leading to tissue responses such as angiogenesis and / or dermal collagen regeneration.

[0263] VIII. Example 8: Treatment of Human Scar Tissue Using Rapid Sonic Pulses

[0264] Another study was conducted to evaluate the reduction of fibrogenic scarring induced by sonic subcutaneous incision. A middle-aged female subject with fibrogenic scarring at a previously healed cesarean section incision site was treated with rapid sonic pulses. The treatment site was marked with a pen, and baseline three-dimensional photographs were taken using an Antera 3D camera (Miravex). Despite the absence of anesthesia, a sonic subcutaneous incision device delivered rapid sonic pulses to a hydrogel-covered treatment site. The rapid sonic pulses delivered by the sonic subcutaneous incision device had an average peak output pressure of approximately 4 to 6 million Pascals and were delivered to the fibrogenic scar site at a frequency of 50 Hz over approximately 6 minutes. In addition, the rapid sonic pulses had a negative pulse component duration of less than 2 microseconds. Participants reported no discomfort during the application of the rapid sonic pulses.

[0265] Six weeks after treatment, three-dimensional photographs of the treated fibrous tissue scarring area were taken again. The results showed that the volume of the fibrous tissue scarring had decreased by approximately 7%, and the height of the fibrous tissue scarring had decreased by approximately 29%.

[0266] The results of the above study support the ability of the sonic subcutaneous cutting device to safely cause tissue disruption, resulting in tissue responses such as the formation of fibrous tissue and the reduction of scar tissue.

[0267] IX. Example 9: Scar Reduction in Fibrous Tissue Using Rapid Sonic Pulses

[0268] A single-site proof-of-concept institutional review board-approved human clinical trial was conducted to evaluate the safety, tolerability, and efficacy of the rapid sonic pulse device for temporary improvement of the appearance of fibrogenic scars. The rapid sonic pulse device generates high-intensity sonic shockwaves at a rapid frequency of 50 pulses per second, capable of disrupting dermal and subcutaneous fibrous structures. The rapid sonic pulse device has the potential to improve scar appearance through both micro-disruption of the scar tissue matrix and downregulation of fibroblasts, which induce scar remodeling. The rapid sonic pulse device has been successfully used in two institutional review board-approved human clinical trials to accelerate laser-based tattoo removal and in a proof-of-concept trial to improve the appearance of cellulite.

[0269] Eleven fibrous scars (i.e., keloid or hypertrophic scars) from 10 participants were treated using a single 6-minute rapid sonic pulse session. Unexpected adverse events (UAEs) and treatment tolerability were recorded immediately after treatment. Scar size and appearance were evaluated using before-and-after photographs taken with a three-dimensional multispectral imaging system (Antera 3D Pro, Miravex, Dublin, Ireland). Images acquired with the Antera 3D Pro were analyzed using proprietary software to assess changes in scar volume and height from pre-treatment to a 12-week follow-up. Participants were followed up for 12 weeks and completed a patient satisfaction survey.

[0270] 3D scar evaluation using before-and after photographs of 11 treated scars demonstrated an average reduction in volume of 29.6% (p<0.01) (range 2% to -48%) and an average reduction in height of 14.6% (p<0.005) (range 0% to -34%). No adverse events occurred with rapid sonic pulse treatment, except for mild erythema and minimal bleeding. The treatment duration was considered tolerable by all participants. The mean pain score was 2.2 (on a scale of -0 to 10, with 10 being the most severe pain). Seven of the ten participants agreed or strongly agreed with scar improvement, two were neutral, and one disagreed. Eight of the ten agreed or strongly agreed to repeat the treatment, one was neutral, and one disagreed. Finally, six of the ten agreed or strongly agreed to recommend the treatment to a friend, three were neutral, and one disagreed.

[0271] Treatment of fibrogenic scars using a rapid sonic pulse device is safe and tolerable. A 12-week follow-up demonstrated that rapid sonic pulses, based on a single, short-duration, non-invasive treatment with minimal pain and satisfactory improvement in most patients, provide significant cosmetic improvement for fibrogenic scars.

[0272] The scope of the patent application is not intended to include, and should not be construed as including, limitations on the means or steps, unless such limitation is expressly stated in one of the given claims using (a plurality of) the phrases “means for” or “steps for”.

[0273] References

[0274] [1]Amore, R., Amuso, D., Leonardi, V., Sbarbati, A., & et al. (2018,May 18). Treatment of dimpling from cellulite. Plast Reconstr Surg GlobOpen, 1-8.

[0275] [2]Bae, S. (2017, 5). Antifibrotic Effects of Vibratory Stimulation. All Dissertations / 1879. Clemson University TigerPrints.

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[10] Widgerow, A. D. (2011). Cellular / extracellular matrix cross-talkin scar evolution and control. Wound Rep Reg (2011) , 19, 117–133.

Claims

1. A sonic subcutaneous cutting device configured to use a plurality of rapid sonic pulses to cause fibrous structure fragmentation, the sonic subcutaneous cutting device comprising: A shell; A pulse generation system is connected to the housing; and A controller is connected to the pulse generation system and configured to cause the pulse generation system to generate a plurality of shock wave pulses. The plurality of shock wave pulses, with a peak output pressure between 1 million Pascals and 30 million Pascals, have a pulse repetition frequency between 50 Hz and 100 Hz, such that the plurality of shock wave pulses are arranged to cause rupture of the fibrofatty diaphragm. The plurality of shock pulses mentioned therein are compression shock pulses having the following characteristics: Positive pulse component, and Negative pulse component, and The negative pulse component has a duration of less than 2 microseconds.

2. The acoustic subcutaneous cutting device according to claim 1, wherein the pulse generation system comprises a plurality of electro-hydraulic EH spark heads.

3. The acoustic subcutaneous cutting device according to any one of claims 1-2, wherein each of the plurality of shock wave pulses has a rise time of less than 500 nanoseconds.

4. The acoustic subcutaneous cutting device according to any one of claims 1-2, wherein each of the plurality of shock wave pulses has a rise time of 150 nanoseconds to 300 nanoseconds.

5. The sonic subcutaneous cutting device according to any one of claims 1-2, wherein the plurality of shock wave pulses have a peak output pressure of 1 million Pascal to 20 million Pascal.

6. The acoustic subcutaneous cutting device according to claim 1 further comprises: A vacuum head is positioned to generate negative pressure at a processing location.

7. The acoustic subcutaneous cutting device according to claim 6 further comprises: A control unit, including: One valve; A motor is connected to the valve and configured to adjust the valve; An indicator, configured to output an indication corresponding to the position of the valve; and A controller is configured to transmit multiple control signals to the motor and the indicator; A conduit connects to the controller and to the vacuum head; and The vacuum head includes: A vacuum head housing, defining a window and one or more ports; A compliant component is connected to the vacuum head housing; One or more sensors are connected to the vacuum head housing; and One or more lamps are connected to the housing of the vacuum head.

8. The sonic subcutaneous cutting device according to claim 6, wherein the controller is integrated with the vacuum head, and wherein the fiber structure comprises a dermal fiber structure, a subcutaneous fiber structure, or both.

9. The sonic subcutaneous cutting device of claim 1, wherein the sonic subcutaneous cutting device is positioned adjacent to a treatment site; and the sonic subcutaneous cutting device is configured to apply a plurality of first shock wave pulses to the treatment site, wherein the plurality of first shock wave pulses are radiated with a peak output pressure between 6 million Pascals and 10 million Pascals and a pulse repetition frequency between 50 Hz and 100 Hz, such that the plurality of first shock wave pulses are configured to cause rupture of the fibrofatty diaphragm.

10. The acoustic subcutaneous cutting device according to claim 9, wherein the plurality of first shock wave pulses are applied during multiple processing durations in a processing period.

11. The sonic subcutaneous cutting device according to any one of claims 9 to 10, wherein the treatment site comprises multiple treatment zones, and wherein the plurality of first shock wave pulses cause the dermal fiber structure, subcutaneous fiber structure, or both at the multiple treatment zones to break.

12. The sonic subcutaneous cutting device according to any one of claims 9 to 10, wherein the sonic subcutaneous cutting device is repositioned to a second treatment area of ​​one of the treatment sites; and the sonic subcutaneous cutting device is further arranged such that: Apply a plurality of second shock wave pulses to the second processing area; and Interrupt the processing time of one of the processing parts.

13. The sonic subcutaneous cutting device according to any one of claims 9 to 10, wherein the treatment site has an area of ​​100 square centimeters.

14. The sonic subcutaneous cutting device according to any one of claims 9 to 10, wherein the treatment site has an area of ​​400 square centimeters.

15. The sonic subcutaneous cutting apparatus according to any one of claims 9 to 10, wherein a treatment period includes applying one or more treatments to one or more treatment areas of the treatment site, wherein the treatment period is repeated daily, weekly or monthly.

16. The sonic subcutaneous cutting apparatus according to any one of claims 9 to 10, wherein the treatment site includes a dermal ridge or depression located within the treatment site, and wherein the plurality of first shock wave pulses are applied to the dermal ridge or depression.

17. The acoustic subcutaneous cutting device according to any one of claims 9 to 10, further comprising: A vacuum head, wherein the vacuum head is applied to the processing area and is configured to generate negative pressure at the processing area.

18. The sonic subcutaneous cutting apparatus of claim 17, wherein cooling air is applied to the treatment site.

19. The sonic subcutaneous cutting device according to claim 17, wherein the vacuum head is further configured to be removed from the treatment site.

20. The acoustic subcutaneous cutting device according to any one of claims 9 to 10, wherein the plurality of first shock wave pulses are emitted from a free-form acoustic reflector.

21. The acoustic subcutaneous cutting apparatus according to any one of claims 9 to 10, wherein the acoustic wavefront of one of the plurality of first shock wave pulses has a rise time of less than 500 nanoseconds.

22. The acoustic subcutaneous cutting apparatus according to any one of claims 9 to 10, wherein the acoustic wavefront of one of the plurality of first shock wave pulses has a rise time of less than 150 nanoseconds to 300 nanoseconds.

23. The acoustic subcutaneous cutting device according to claim 9, wherein the treatment duration of one treatment area of ​​the treatment site is one minute, and wherein the treatment time of one treatment site is twenty-five to forty-five minutes.

24. The acoustic subcutaneous cutting device according to any one of claims 9 to 10, wherein the plurality of first shock wave pulses have a peak output pressure of 6 million Pascals and wherein the probe has a pulse repetition frequency of 100 Hz.

25. The sonic subcutaneous cutting device according to claim 24, wherein the treatment duration of one treatment area of ​​the treatment site is three minutes, and wherein the treatment time of one treatment site is twenty-five to forty-five minutes.

26. The acoustic subcutaneous cutting apparatus according to any one of claims 9 to 10, wherein each treatment area of ​​the treatment site is subjected to 500 to 60,000 acoustic pulses.

27. The sonic subcutaneous cutting device according to claim 9, wherein the treatment area corresponding to one of the treatment sites is within a depth of 0.5 cm to 6 cm from the outside of the treatment site.

28. The sonic subcutaneous cutting device according to claim 9, wherein the treatment site is a genital, buttock, thigh, abdomen, waist, upper arm area, part of the genital, part of the buttock, part of the thigh, part of the abdomen, part of the waist, or part of the upper arm area.

29. The acoustic subcutaneous cutting device according to claim 9, wherein the plurality of first shock wave pulses correspond to a plurality of unfocused and non-cavitation shock waves.

30. The acoustic subcutaneous cutting device according to claim 9, wherein the plurality of first shock wave pulses have at least 0.015 millijoules per square millimeter.

31. The acoustic subcutaneous cutting device according to claim 9, wherein the plurality of first shock wave pulses are between 0.01 millijoules per square millimeter and 5 millijoules per square millimeter.

32. The acoustic subcutaneous cutting device according to claim 9, wherein the plurality of first shock wave pulses are substantially planar shock waves.

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