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WO2025208085A1 - Thérapie par ultrasons photo-médiée pour malformation vasculaire cutanée - Google Patents

Thérapie par ultrasons photo-médiée pour malformation vasculaire cutanée

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Publication number
WO2025208085A1
WO2025208085A1 PCT/US2025/022126 US2025022126W WO2025208085A1 WO 2025208085 A1 WO2025208085 A1 WO 2025208085A1 US 2025022126 W US2025022126 W US 2025022126W WO 2025208085 A1 WO2025208085 A1 WO 2025208085A1
Authority
WO
WIPO (PCT)
Prior art keywords
laser
treatment
ultrasound
laser pulse
wattle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/022126
Other languages
English (en)
Inventor
Xinmai Yang
Xueding Wang
Yannis Paulus
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Kansas
University of Michigan System
Original Assignee
University of Kansas
University of Michigan System
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University of Kansas, University of Michigan System filed Critical University of Kansas
Publication of WO2025208085A1 publication Critical patent/WO2025208085A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00779—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00994—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0034—Skin treatment

Definitions

  • Cutaneous vascular malformations such as port wine stain (PWS), which occurs in 0.3 to 0.5% of newborns, are often a cause of great concern to patients for both medical and cosmetic reasons.
  • Laser irradiation with flashlamp-pumped pulsed dye lasers e.g., photothermolysis therapy (PTT)
  • PTT photothermolysis therapy
  • PDT offers an alternative method for treatment of PWS.
  • PDT requires the systemic injection of photosensitizers, which necessitates the avoidance of sun exposure for up to a week after treatment, time-dependent infusion, and systemic side-effects with suboptimal treatment effect.
  • effective treatment methods with limited side effects are needed for PWS and other CVM.
  • the ultrasound burst has a peak negative pressure of about 0.1 to about 5 MPa. In some embodiments, the ultrasound burst has a peak negative pressure of 0.5-1.5 MPa. In some embodiments, the ultrasound burst has a peak negative pressure of 0.70-0.75 MPa.
  • the laser pulse has a laser fluence greater than 1 mJ/cm 2 . In some embodiments, the laser pulse has a laser fluence greater than 100 mJ/cm 2 . In some embodiments, the laser fluence is less than 1 J/cm 2 . In some embodiments, the laser fluence is between 150 mJ/cm 2 and 1 J/cm 2 . In some embodiments, the laser fluence is between 500 mJ/cm 2 and 1 J/cm 2 . In some embodiments, the laser fluence is about 700 mJ/cm 2 . In some embodiments, the laser fluence is between about 250 mJ/cm 2 and about 500 mJ/cm 2 .
  • the laser pulse and ultrasound burst are repeated at a repetition frequency of between 1 Hz and 1000 Hz. In some embodiments, the repetition frequency is about 5 Hz to about 20 Hz. In some embodiments, the repetition frequency is about 15 Hz. In some embodiments, the repetition frequency is about 10 Hz.
  • the applying lasts for at least 10 seconds. In some embodiments, the applying lasts for 1 to 10 minutes. In some embodiments, the applying lasts for 4 to 6 minutes.
  • FIGS. 1A-1C show representative treatment outcomes from a chicken wattle treated with Photo-mediated Ultrasound Therapy (PUT).
  • FIG. 1 A shows photographs of the chicken wattle taken before and at different time points (days 1 and 14) after PUT treatment as well as laser- only and ultrasound-only treatments.
  • FIG. IB shows the B-scan OCT-A images overlapped on the B-scan OCT images acquired along the center of the treatment region shown in a.l-a.3. Images were acquired immediately before and at different time points (1 day, 14 days) after PUT treatment.
  • FIG. 1C shows maximum intensity projection images of 3D OCT-A of the areas marked in the red dash squares. The white circles mark the treated area. 3D, three-dimensional; FUS, focused ultrasound; OCT, optical coherence tomography; OCT-A, optical coherence tomography angiography; PUT, photo-mediated ultrasound therapy.
  • FIGS. 2A-D show the quantitative assessment of vessel density changes in chicken wattles treated with either PUT, laser only, or ultrasound only.
  • FIG. 2A shows photographs of a chicken wattle with 1 PUT-, 1 ultrasound-only-, and 1 laser-only-treated regions at different time points.
  • FIG. 2B shows maximum intensity projection images of 3D OCT-A (0-150 pm depth in the dermis) of the PUT -treated region at different time points.
  • FIG. 2C shows vessel density maps generated by binarization of the maximum intensity projection images in FIG. 2B.
  • 3D three-dimensional; FUS, focused ultrasound; OCT, optical coherence tomography; OCT-A, optical coherence tomography angiography; PUT, photo-mediated ultrasound therapy.
  • FIGS. 3 A-3D show H&E-stained section of a wattle tissue harvested on day 21 after PUT treatment.
  • FIG. 3 A is an H&E-stained section of a wattle tissue harvested on day 21 after PUT treatment, 10 magnification. The red dash square marks the treated area.
  • FIG. 3B is an enlarged view of a treated area close to the epidermis (0-400 pm depth), X20 magnification. No blood vessels remain in the treated region.
  • FIG. 3C is an enlarged view of a treated area at 400-800 pm depth, X20 magnification. Only large vessels remain.
  • FIG. 3D is an enlarged view of an untreated area where many blood vessels can be seen, X20 magnification.
  • Bv denotes blood vessels
  • Ep denotes epidermis
  • De denotes dermis.
  • PUT photo-mediated ultrasound therapy.
  • FIGS. 7A-7D show safety evaluation on day 3 after PUT treatment.
  • FIG. 7A is caspase- 3-stained section of a wattle tissue, including a treated area.
  • FIG. 7B is caspase-3 -stained section of a wattle tissue that was untreated.
  • FIG. 7C is an MTC-stained section of the same wattle tissue in FIG. 7A, including a treated area.
  • FIG. 7D is an MTC-stained section of the same wattle tissue in FIG. 7B that was untreated.
  • MTC Masson’s trichrome
  • PUT photo-mediated ultrasound therapy.
  • FIGS. 8 A and 8B are a data processing schematic. Two cases are presented for the chicken wattle tissue immediately before PUT treatment (FIG. 8A) and 14 days after PUT treatment (FIG. 8B).
  • the left hand top images (a.1 and b.l) show the B-scan OCT-A images overlapped on the B-scan OCT images along the center of treatment regions marked in the center image.
  • the left hand middle images (a.2 and b.2) show the surface of the skin and the area of the epidermis segmented from the B-scan OCT images.
  • the left hand lower images (a.3 and b.3) show the segmented layer with 0-150 pm depth in the dermis for analyzing the OCT-A signals.
  • the middle images (a.4 and b.4) show en face projections of the OCT-A signals in the segmented layer.
  • the right hand images (a.5 and b.5) show binarization results of the en face projections of the OCT-A signals in the segmented layer.
  • OCT optical coherence tomography
  • OCT-A optical coherence tomography angiography
  • PUT photo-mediated ultrasound therapy.
  • FIGS. 9A-9D show a system schematic and experiment setup for PUT treatment of chicken wattle.
  • FIG. 9A is a detailed schematic of the integrated ultrasound and laser system for PUT treatment of chicken wattle.
  • FIG. 9B is a photo of the experimental setup showing positions of an agar-gelatin gel cone and a PDMS pad.
  • FIG. 9C is a photo of a chicken wattle positioned between the PDMS and the gel cone during the treatment.
  • FIG. 9D is a pretreatment picture of a chicken wattle, with marked circles indicating the spots for treatment.
  • FUS focused ultrasound
  • PDMS polydimethylsiloxane
  • PUT photo-mediated ultrasound therapy.
  • FIGS. 10A-10C show the theoretical modeling of the pre-existing bubble dynamics under different light fluence and ultrasound pressure during PUT treatment of a blood vessel.
  • FIG. 10A left (a.1), shows a simulated photoacoustic (PA) wave near the center of a blood vessel with a diameter of 0.1 mm when illuminated by a 3-ns light pulse at 1064 nm wavelength.
  • FIG. 10A, right (a.3) shows a combined PA waveform and ultrasound wave, where the PA wave is synchronized at the negative phase of an ultrasound cycle.
  • FIG. 10A left (a.1), shows a simulated photoacoustic (PA) wave near the center of a blood vessel with a diameter of 0.1 mm when illuminated by a 3-ns light pulse at 1064 nm wavelength.
  • FIG. 10A, center (a.2) shows concurrently applied ultrasound bur
  • FIG. 10B shows simulated bubble size evolution under different combinations of treatment parameters, including 0.6 MPa ultrasound and 100 mJ/cm 2 light fluence (FIG. 10B, left (b. l)), 0.8 MPa ultrasound and 120 mJ/cm 2 light fluence (FIG. 10B, center (b.2)), and 1.0 MPa ultrasound and 120 mJ/cm 2 light fluence (FIG. 10B, right (b.3)).
  • R/R0 stands for dynamic bubble size R over its initial size R0.
  • FIG. 10C, left shows a simulated rectified diffusion threshold (e.g., cavitation threshold) for different initial bubble sizes and at different levels of light fluence.
  • FIG. 10C shows a simulated rectified diffusion threshold (e.g., cavitation threshold) for different initial bubble sizes and at different levels of light fluence.
  • FIG. 10C shows a simulated rectified diffusion threshold (e.g., cavitation threshold) for different initial bubble sizes and at different levels of light fluence.
  • 10C right, shows a simulated dynamics of a 100-nm pre-existing bubble under the treatment of different combinations of ultrasound rarefaction pressure and light fluence, where the bubble dissolves (e.g., no treatment effect) in the blue region and grows (e.g., effective treatment of blood vessel) in the yellow region.
  • the dashed red line indicates the ultrasound pressure for cavitation threshold which decreases with the increased light fluence.
  • FIGS. 15A-15E show histopathological analyses across the entire section of a chicken wattle conducted at Day 7 post-treatment.
  • FIG. 15A is an H&E stained section, including the original photo and the zoom-in photos from two treated areas (a.2 from the top and a.3 from the bottom of the treated region) vs. an untreated area (a.l) as the control. Endothelial necrosis can be seen in both the top (a.2) and the bottom (a.3) of the treated region.
  • FIG. 15B is CD31 stained IHC from an adjacent section, including the original photo and the zoom-in photos from the same three areas (b.2 and b.3 from the top and the bottom of the treated region, and b.l from the untreated area).
  • rat monoclonal primary antibody was diluted to 1 :50 in DaVinci Diluent (Biocare Medical, catalog number PD900) and incubated for 60 minutes, followed by detection using a Rat-on-Mouse HRP -Polymer (Biocare Medical, catalog number RT517) 2-step probe-polymer incubation for 10 and 30 minutes, respectively.
  • the diaminobenzidine was enhanced with diaminobenzidine Sparkle (Biocare Medical, catalog number DS830).
  • Negative control samples consisted of naive rat sera (NC915, Innovex Biosciences) applied in place of the primary antibody, under the same conditions.
  • FIG. 1 was also evaluated by OCT-A.
  • the red square shows the OCT scanning region on the wattle.
  • the images in FIG. IB were obtained by overlapping the B-scan OCT-A images presenting the blood perfusion information over the B-scan OCT images presenting the tissue structural information.
  • the B-scan was through the middle of the treatment spot marked by a dash blue line.
  • the blood perfusion was stopped the next day after PUT treatment (FIG. IB, day 1). This cessation in blood perfusion induced by PUT persisted until at least 14 days after the treatment (FIG. IB, day 14), which was the end of the observation period and when the chicken was killed for histopathology analysis.
  • FIG. IB day 1
  • FIGS. 3-5 show the H&E-stained histology results.
  • FIG. 3A is a section of wattle tissue harvested on day 21 after the PUT treatment, and the treatment area is marked with a red dash square.
  • the blood vessel lumens completely disappeared at a depth of 0 to 400 pm from the wattle surface, as shown in FIG. 3B.
  • most of the capillary lumens are not visible in the 400-800 pm depth, except for 2 large blood vessels at the depth of 800 pm (FIG. 3C), indicating a treatment depth of 700 pm.
  • the untreated region had abundant blood vessels, as illustrated in FIG. 3D.
  • FIG. 5 shows H&E-stained sections of wattle tissues treated with either PUT (FIGS. 5A- 5D), laser-only (FIG. 5E), or ultrasound only (FIG. 5F).
  • the tissue sections showing the outcome from PUT were harvested on days 1, 7, 14, and 21 after the treatment.
  • the vessels were occluded with red blood cells, whereas on days 14 and 21 after the PUT treatment, the vessel lumens in the treated regions disappeared.
  • the sections treated with either ultrasound only or laser only all blood vessels were completely intact on day 21 after the treatment.
  • FIGS. 7A and 7B show caspase-3 negative in both the untreated area and the dermis of the treated area. Some localized activations of caspase-3 were found in the epidermis of the treated area, which however were very minor. As shown by the MTC-stained histology results in FIGS. 7C and 7D, show the collagen inside the treated area has structure and morphology similar to those in the untreated area, indicating no collateral collagen damage induced by the treatment.
  • the transducer was powered by a radio-frequency power amplifier (2100L, ENI, Rochester, NY) through an impedance matching network provided by Sonic Concepts.
  • a pulse delay generator (Model DG355, Stanford Research Systems) was employed to synchronize the triggers for the laser and the ultrasound systems, ensuring that the light pulse reached the target during one of the negative phase of the ultrasound burst.
  • the target was a blood vessel mimicking phantom which was a soft and optically transparent silicone tube (inner diameter: 0.3 mm, outer diameter: 0.6 mm, LiveoTM Silicone Laboratory Tubing, Fisher Scientific) filled with human whole blood obtained from the University of Michigan Blood Center. Driven by a pump, the blood was circulated through the tube at a speed of 1 cm per second.
  • the tube was immersed in a water bath filled with degassed water.
  • the blood vessel was imaged continuously using an ultrasound imaging system (ZS3, Zonare Medical Systems, Inc., Mountain View, CA) in the B-mode working with a 10 MHz linear probe.
  • FIG. 11C shows the measured cavitation probability from the blood vessel phantom treated by a combination of different levels of ultrasound pressure and light fluence. The quantified cavitation probability at each point in this map was calculated by counting the number of frames with detected cavitation bubbles from a total of 100 frames of ultrasound images. The points along the dashed line in FIG. 11C have the same level of cavitation probability.
  • the light fluence of 20 mJ/cm 2 plus the ultrasound pressure of 1.4 MHz yields a similar cavitation probability as the light fluence of 200 mJ/cm 2 plus the ultrasound pressure of 0.8 MPa.
  • This experimental result from the phantom study indicates again that similar cavitation activities can be achieved with weaker light fluence in combination with stronger ultrasound pressure (the situation in deep skin) or stronger light fluence in combination with weaker ultrasound (the situation in superficial skin), which is consistent with the finding in FIG. 10 from the theoretical modeling.
  • the ultrasound wave was focused at the bottom of the wattle. Based on the precalibration in a water tank using a calibrated needle hydrophone (Model, Onda), the ultrasound pressure arriving at the top surface of the wattle was 0.91 MPa, while the ultrasound
  • H&E stained slides were used to assess treatment depth by measuring the depth of inflammation and vascular necrosis performed by a pathologist.
  • CD31 stained slides were used to quantify treatment efficacy by comparing the vascular densities inside and outside the treated area.
  • RMP stains were utilized to assess the safety of the treatment by measuring the collagen densities inside and outside the treated area.
  • FIG. 13A displays the photographs of wattle skin taken using a skin imaging camera immediately before treatment (Day 0), immediately post treatment (Day 1), and at Day 7 posttreatment. All the three regions marked by the white dashed circles received the same PUT treatment. A clearly visible change in color can be observed at Day 1 from both the top and the bottom sides of the wattle, suggesting that the treatment effect penetrated the entire chicken wattle.
  • OCT-A images acquired from both the top and the bottom sides of the treated areas were compared with an untreated area as the control.
  • FIG. 13B blood perfusion ceased immediately after PUT treatment in all the treated regions, and this cessation of blood perfusion persisted for the entire observation period of 7 days post-treatment.
  • Quantitative assessment of PUT treatment outcomes was performed by analyzing the vessel density map generated from the 3D OCT-A images that were acquired before and at various time points post-treatment, as shown in FIG. 13C. Each data point represents the mean ⁇ standard deviation (SD) for each group.
  • SD standard deviation
  • FIG. 14 shows the representative photos of H&E, CD31, and RMP stained slides.
  • the unique architecture of chicken wattle can be seen in FIG. 14A as well as FIG. 15A.
  • the full thickness of the tissue comprises epidermis on both sides, with dermis underneath on both sides, and a very scant amount of subcutis in the center.
  • acute vascular necrosis and mild inflammation were noted in multiple capillary layers in the superficial dermis at both sides, leading to vascular occlusion.
  • Equation (2) gives the formula of PB, where o is the surface tension coefficient, p is the viscosity of the fluid, and p g is the pressure inside the bubble.
  • p g can be calculated from Eller and Flynn’s zero-order solution to the diffusion equation, expressed as equation (3), where D is the diffusion constant of the gas in the liquid, no is the number of moles of gas initially present in the bubble, and r is the nonlinear time defined using equation (4-6).
  • TJ is the polytropic exponent of the gas
  • Co is the saturation concentration of the gas in the liquid
  • Ci is the initial concentration of gas in the liquid far from the bubble
  • Ro is the initial equilibrium radius of the bubble
  • Ro is the time-varying equilibrium bubble radius calculated using ideal gas law expressed in equation (7), where R g is the universal gas constant and T a is the absolute temperature.
  • P g is a function of n, and, therefore, equations (3) and (6) need to be coupled and solved simultaneously.
  • Equation (3) the term p (t + is the applying pressure, which is composed of the applied ultrasound pressure and the photoacoustic (PA) pressure produced by a light pulse.
  • the distribution of initial pressure produced by the light pulse can be calculated by equation (8), where T is the light pulse width defined at the full width of half maximum, and ps is the initial pressure distribution of the absorbing object.
  • equation (9) the pressure response for a delta heating of an arbitrary absorbing object is given by equation (9), where p o could be calculated using equation (10).

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Abstract

L'invention concerne des systèmes et des procédés pour diminuer la densité de vaisseaux sanguins, éliminer des vaisseaux sanguins ou des capillaires, et/ou traiter une malformation vasculaire cutanée (par exemple, un angiome plan) chez un sujet. Les procédés comprennent l'application d'une ou de plusieurs impulsions laser synchronisées de manière spatio-temporelle avec une ou plusieurs rafales d'ultrasons sur au moins une partie de la zone cible (par exemple, une surface de peau ou un tissu atteint jusqu'à 3 mm à partir de la surface de la peau).
PCT/US2025/022126 2024-03-29 2025-03-28 Thérapie par ultrasons photo-médiée pour malformation vasculaire cutanée Pending WO2025208085A1 (fr)

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US63/571,599 2024-03-29

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090227909A1 (en) * 2008-03-04 2009-09-10 Sonic Tech, Inc. Combination Ultrasound-Phototherapy Transducer
US20220071705A1 (en) * 2020-09-04 2022-03-10 University Of Kansas Ultrasound-enhanced laser thrombolysis with endovascular laser and high-intensity focused ultrasound
US20230083661A1 (en) * 2016-05-02 2023-03-16 University Of Kansas Method and apparatus for removing microvessels

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090227909A1 (en) * 2008-03-04 2009-09-10 Sonic Tech, Inc. Combination Ultrasound-Phototherapy Transducer
US20230083661A1 (en) * 2016-05-02 2023-03-16 University Of Kansas Method and apparatus for removing microvessels
US20220071705A1 (en) * 2020-09-04 2022-03-10 University Of Kansas Ultrasound-enhanced laser thrombolysis with endovascular laser and high-intensity focused ultrasound

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