Granted Patent
B2
US 12,635,974 · App. 17/016,304 · Granted May 26, 2026
Methods and systems for using phase change nanodroplets to enhance sonothrombolysis
Inventors:
Paul Alexander Dayton (Carrboro, NC); Jinwook Kim (Chapel Hill, NC); Xiaoning Jiang (Cary, NC); Zhen Xu (Ann Arbor, MI)
Assignees:
The Regents of the University of Michigan; North Carolina State University; The University of North Carolina at Chapel Hill
A61B8/0891A61B8/085A61B8/481A61B8/5246A61B17/22004A61M5/142A61N7/02A61B2017/22008A61B2017/22014A61B2017/22088A61B2017/22089A61N2007/0039
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Abstract
A method for using metastable perfluorocarbon nanodroplets for ultrasonic lysis of blood clots includes administering metastable perfluorocarbon nanodroplets into a blood vessel that includes or that leads to a blood vessel that includes a blood clot, the metastable perfluorocarbon nanodroplets each have a liquid core comprising a perfluorocarbon material that has a boiling point below 25° C. at atmospheric pressure and that remains stable in liquid form at 25° C. at atmospheric pressure. The method further includes applying ultrasound energy to the perfluorocarbon nanodroplets within or surrounding the blood clot, causing the perfluorocarbon nanodroplets to vaporize and convert to bubbles, which cavitate and lyse the blood clot.
Claims (47)
1 . A method for generation of cavitation internal to a blood clot mass greater than would be achievable with microbubble cavitation agents for a given level of applied ultrasound energy, the method comprising:
administering metastable liquid perfluorocarbon nanodroplets into a blood vessel that includes or leads to a blood vessel that includes a blood clot, where the metastable liquid perfluorocarbon nanodroplets each have a liquid core comprising a perfluorocarbon material that has a boiling point below 25° C. at atmospheric pressure and the liquid core is encapsulated within a shell, where the metastable liquid perfluorocarbon nanodroplets are in a metastable state and remain stable in liquid form at 25° C. at atmospheric pressure, and where the metastable liquid perfluorocarbon nanodroplets have diameters sufficiently small to penetrate into the blood clot mass, wherein the diameters range from 10 nanometers to 750 nanometers;
allowing for at least some of the metastable liquid perfluorocarbon nanodroplets to penetrate the blood clot; and
applying ultrasound energy to the blood clot mass, causing the metastable liquid perfluorocarbon nanodroplets within the blood clot, causing the liquid cores of the metastable liquid perfluorocarbon nanodroplets that penetrated the blood clot, to convert from a liquid state to a gaseous state due to the application of the ultrasound energy, resulting in cavitation occurring within the blood clot,
wherein a metric of cavitation occurring within the blood clot due to the cavitation from the metastable liquid perfluorocarbon nanodroplets that penetrated the blood clot and converted to the gaseous state exceeds the metric of cavitation that would occur within the blood clot due to microbubbles administered externally to the blood clot and to which the ultrasound energy is applied, wherein applying the ultrasound energy includes applying the ultrasound energy intravascularly using an ultrasound transducer, wherein the nanodroplets that penetrate the blood clot spatially control cavitation delivery to reduce heating of tissue surrounding the blood clot, and wherein the cavitation occurring within the blood clot causes lysis of the blood clot.
2 . The method of claim 1 wherein the metastable liquid perfluorocarbon nanodroplets are allowed to penetrate the blood clot prior to applying the ultrasound energy that causes the liquid cores of the nanodroplets to convert from the liquid state to the gaseous state.
3 . The method of claim 1 wherein the applying of the ultrasound energy causes the liquid cores of the metastable liquid perfluorocarbon nanodroplets to convert from the liquid state to the gaseous state at or adjacent to a surface of the blood clot, cavitate, and mediate lysis of the blood clot.
4 . The method of claim 1 wherein the lysis of the blood clot with the metastable liquid perfluorocarbon nanodroplets occurs at a rate which is at least double than a rate of lysis of the blood clot without the presence of the metastable liquid perfluorocarbon nanodroplets at the same acoustic parameters.
5 . The method of claim 1 wherein the metastable liquid perfluorocarbon nanodroplets have diameters ranging from 10 nm to 300 nm.
6 . The method of claim 1 wherein applying the ultrasound energy includes applying the ultrasound energy with a peak negative pressure that is less than 3 megapascals.
7 . The method of claim 1 wherein applying the ultrasound energy includes applying the ultrasound energy with a peak negative pressure that is less than 5.9 megapascals.
8 . The method of claim 1 wherein applying the ultrasound energy includes applying the ultrasound energy with a peak negative pressure that is less than 12 megapascals.
9 . The method of claim 1 wherein the frequency used to apply the ultrasound energy is selected from a range of 300 KHz to 2 MHz.
10 . The method of claim 1 wherein the frequency used to apply the ultrasound energy is selected from a range of 2 MHz to 10 MHZ.
11 . The method of claim 1 wherein a plurality of the metastable liquid perfluorocarbon nanodroplets can be vaporized at less than 4.5 MPa with 15 cycles at 1 MHz and 25° C.
12 . The method of claim 1 wherein applying the ultrasound energy includes using ultrasound pulses having a duty cycle of no more than 45%.
13 . The method of claim 1 wherein applying the ultrasound energy includes applying the ultrasound energy with an acoustic intensity of no more than 34.8 Watts per square centimeter.
14 . The method of claim 1 wherein applying the ultrasound energy includes applying the ultrasound energy with an acoustic intensity of no more than 15 Watts per square centimeter.
15 . The method of claim 14 wherein ultrasound is utilized to form an image of the blood clot and acoustic signals of cavitation are overlaid on the image of the clot.
16 . The method of claim 1 wherein applying the ultrasound energy includes applying the ultrasound energy with an acoustic intensity of no more than 5.2 Watts per square centimeter.
17 . The method of claim 1 wherein the blood clot comprises a retracted blood clot.
18 . The method of claim 1 wherein the metastable liquid perfluorocarbon nanodroplets comprise at least decafluorobutane or perfluoropropane.
19 . The method of claim 1 wherein the shell of each of the metastable liquid perfluorocarbon nanodroplets comprises a lipid, a polymer, or a protein material surrounding the perfluorocarbon core.
20 . The method of claim 1 wherein acoustic signals from the cavitation are detected by a transducer and utilized to indicate the presence or location of the cavitation occurring at near or within the blood clot.
21 . The method of claim 1 where acoustic signals from the cavitation are detected by a transducer, and energy from a 2 nd harmonic and higher from the shells increasing in diameter and bursting is used to indicate the presence and/or location of the cavitation occurring near or within the blood clot.
22 . The method of claim 1 comprising administering a material for enhancing breakdown of the blood clot in conjunction with the metastable liquid perfluorocarbon nanodroplets and ultrasound energy.
23 . The method of claim 22 wherein the material comprises an anti-coagulant.
24 . The method of claim 22 wherein the material for enhancing breakdown of the blood clot comprises a tissue plasminogen activator.
25 . The method of claim 1 comprising using ultrasound to obtain an image of the blood clot at a first frequency and wherein applying the ultrasound energy causing the cavitation comprises applying the ultrasound energy at a second frequency that is at least double the first frequency.
26 . The method of claim 1 comprising using ultrasound to obtain an image of a blood clot within a blood vessel at a first frequency which is at least double a frequency of the ultrasound energy causing the cavitation.
27 . The method of claim 1 wherein the metric of cavitation occurring within the blood clot comprises a ratio of cavitation within the blood clot to a total cavitation occurring within and outside of the blood clot.
28 . The method of claim 1 wherein the metastable liquid perfluorocarbon nanodroplets comprise metastable liquid perfluorobutane nanodroplets.
29 . A system for generation of cavitation internal to a blood clot mass greater than would be achievable with microbubble cavitation agents for a given level of applied ultrasound energy, the system comprising:
means for administering metastable liquid perfluorocarbon nanodroplets into a blood vessel that includes or that leads to a blood vessel that includes a blood clot and for allowing at least some of the metastable liquid perfluorocarbon nanodroplets to penetrate the blood clot, where the metastable liquid perfluorocarbon nanodroplets each have a liquid core comprising a perfluorocarbon material that has a boiling point below 25° C. at atmospheric pressure and the liquid core is encapsulated within a shell, where the metastable liquid perfluorocarbon nanodroplets are in a metastable state and would remain stable in liquid form at 25° C. at atmospheric pressure, and where the metastable liquid perfluorocarbon nanodroplets have diameters sufficiently small to penetrate into the blood clot mass, wherein the diameters range from 10 nanometers to 750 nanometers; and
an ultrasound transducer for applying ultrasound energy intravascularly to the blood clot mass, causing the liquid cores of the metastable liquid perfluorocarbon nanodroplets within and surrounding the blood clot to convert from a liquid state to a gaseous state due to the application of the ultrasound energy, resulting in cavitation occurring within the clot,
wherein a metric of cavitation occurring within the blood clot due to the cavitation from the metastable liquid nanodroplets that penetrated the blood clot and converted to the gaseous state exceeds the metric of cavitation that would occur within the blood clot due to microbubbles administered externally to the blood clot and to which the ultrasound energy is applied, and
wherein the nanodroplets that penetrate the blood clot spatially control cavitation delivery to reduce heating of tissue surrounding the blood clot and the cavitation occurring within the blood clot causes lysis of the blood clot.
30 . The system of claim 29 wherein the means for administering comprises an infusion pump.
31 . The system of claim 29 wherein applying the ultrasound energy includes applying the ultrasound energy with a peak negative pressure that is less than 3 megapascals.
32 . The system of claim 29 wherein applying the ultrasound energy includes applying the ultrasound energy with a peak negative pressure that is less than 5.9 megapascals.
33 . The system of claim 29 wherein applying the ultrasound energy includes applying the ultrasound energy with a peak negative pressure that is less than 12 megapascals.
34 . The system of claim 29 wherein the frequency used to apply the ultrasound energy is selected from a range of 300 KHz to 2 MHz.
35 . The system of claim 29 wherein the frequency used to apply the ultrasound energy is selected from a range of 2 MHz to 10 MHz.
36 . The system of claim 29 comprising means for administering a material for enhancing breakdown of the blood clot in conjunction with the metastable liquid perfluorocarbon nanodroplets and ultrasound energy.
37 . The system of claim 29 comprising means for generating an image of the blood clot with acoustic signals from cavitation overlaid on the image of the blood clot.
38 . The system of claim 29 wherein the metric of cavitation occurring within the blood clot comprises a ratio of cavitation within the blood clot to a total cavitation occurring within and outside of the blood clot.
39 . The system of claim 29 wherein the metastable liquid perfluorocarbon nanodroplets comprise metastable liquid perfluorobutane nanodroplets.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 30, 2021
From: DAYTON, PAUL ALEXANDER; KIM, JINWOOK
To: THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
Reel/Frame 056091/0288 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 14, 2021
From: XU, ZHEN
To: THE REGENTS OF THE UNIVERSITY OF MICHIGAN
Reel/Frame 054924/0787 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 18, 2020
From: JIANG, XIAONING
To: NORTH CAROLINA STATE UNIVERSITY
Reel/Frame 053817/0250 →
Continuity (4)
Continuation In Part
16317983
Provisional Application
62897759
· Sep 9, 2019
Provisional Application
62362687
· Jul 15, 2016
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