IP Library Granted Patent US 11,911,574
Granted Patent B2
US 11,911,574 · App. 16/904,297 · Granted Feb 27, 2024

Fortified balloon inflation fluid for plasma system to disrupt vascular lesions

Inventors: Daniel Frank Massimini (Brooklyn Park, MN); Daniel Lee Krautkremer (Plymouth, MN); Haiping Shao (Plymouth, MN); Roger W. McGowan (Otsego, MN)
Assignee: Boston Scientific Scimed, Inc.
A61M25/0133A61B17/22A61B18/245A61B18/26A61L27/20A61M25/0009A61M25/0155A61M25/09A61B2017/22062A61B2018/0022A61B2018/00285A61B2018/2261A61B2018/2266A61B2018/2277A61B2018/2294A61B2018/263A61B2090/306A61L2400/12A61M2025/09008A61M2025/09183A61M2202/0415A61M2205/3592A61M2205/587
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Quick Facts
Patent No.
US 11,911,574
App. No.
16/904,297
Granted
Feb 27, 2024
Kind
B2
Abstract

A catheter system for imparting pressure to induce fractures at a treatment site within or adjacent a blood vessel wall includes a catheter, a fortified balloon inflation fluid and a first light guide. The catheter includes an elongate shaft and a balloon that is coupled to the elongate shaft. The balloon has a balloon wall and can expand to a first expanded configuration to anchor the catheter in position relative. The fortified balloon inflation fluid can expand the balloon to the first expanded configuration. The fortified balloon inflation fluid includes a base inflation fluid and a fortification component. The fortification component reduces a threshold for inducing plasma formation in the fortified balloon inflation fluid compared to the base inflation fluid. The fortification component can include at least one of carbon and iron. The first light guide is disposed along the elongate shaft and is positioned at least partially within the balloon. The first light guide is in optical communication with a light source and the fortified balloon inflation fluid. The light source provides sub-millisecond pulses of a light to the first light guide so that plasma formation and rapid bubble formation occur in the fortified balloon inflation fluid, thereby imparting pressure waves upon the treatment site.

Claims (30)

1. A catheter system for imparting pressure to induce fractures at a treatment site within or adjacent a blood vessel wall, comprising:

a catheter configured to advance to the treatment site, the catheter comprising an elongate shaft and a balloon that is coupled to the elongate shaft, the balloon being configured to expand to a first expanded configuration suitable for anchoring the catheter in position relative to the treatment site;

a fortified balloon inflation fluid that is configured to expand the balloon to the first expanded configuration, the fortified balloon inflation fluid including a base inflation fluid and a fortification component, the fortification component being configured to reduce a threshold for inducing plasma formation in the fortified balloon inflation fluid compared to the base inflation fluid, wherein the fortification component includes one of carbon and iron, and wherein the fortification component is provided as a fortification component coating that is disposed on a surface of a structure that is in fluid communication with the base inflation fluid; and

a first light guide that is disposed along the elongate shaft and at least partially within the balloon, the first light guide being configured to be in optical communication with a light source and the fortified balloon inflation fluid, the light source being configured to provide sub-millisecond pulses of a light to the first light guide so that plasma formation and rapid bubble formation occur in the fortified balloon inflation fluid, thereby imparting pressure waves upon the treatment site, the fortified balloon inflation fluid including absorptive agents having an absorption maxima of greater than 10 nanometers and less than 2.5 micrometers.

2. The catheter system of claim 1 wherein the fortification component includes an iron dextran.

3. The catheter system of claim 2 wherein the iron dextran is present in the fortified balloon inflation fluid at a concentration of from at least 0.0001 millimoles per liter (mmol/L) to 1.0 mmol/L.

4. The catheter system of claim 1 wherein the fortification component includes nanoparticles.

5. The catheter system of claim 1 wherein the fortification component includes one of iron nanoparticles, gold nanoparticles, copper nanoparticles, carbon nanoparticles, carbon nanotubes, gold-coated carbon nanotubes, and copper-coated carbon nanotubes.

6. The catheter system of claim 1 wherein the base inflation fluid includes saline and contrast medium in a ratio of saline to contrast medium of from 25:75 volume percent to 75:25 volume percent.

7. The catheter system of claim 1 wherein the fortification component is configured to modify one of viscosity, density, and surface tension of the fortified balloon inflation fluid compared to the base inflation fluid.

8. The catheter system of claim 1 wherein the elongate shaft defines an inflation lumen, wherein the inflation lumen is in fluid communication with the balloon at a distal portion of the elongate shaft and in fluid communication with a fluid source at a proximal end of the elongate shaft.

9. The catheter system of claim 1 wherein the fortification component coating is disposed on the elongate shaft.

10. The catheter system of claim 1 wherein fortified balloon inflation fluid includes a contrast agent that includes one of diatrizoate, metrizoate, iothalamate, ioxaglate, iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol.

11. A method for generating pressure waves to induce fractures at a treatment site within or adjacent a vessel wall of a blood vessel, the method comprising the steps of:

advancing a catheter to the treatment site within the blood vessel, the catheter comprising an elongate shaft and a balloon coupled to the elongate shaft;

disposing a first light guide along the elongate shaft so that the first light guide is positioned at least partially within the balloon;

expanding the balloon with a fortified balloon inflation fluid to a first expanded configuration suitable for anchoring the catheter in position relative to the treatment site, the fortified balloon inflation fluid comprising a base inflation fluid and a fortification component, the fortification component being configured to reduce a threshold for inducing plasma formation in the fortified balloon inflation fluid compared to the base inflation fluid, wherein the fortification component includes one of carbon and iron, and wherein the fortification component is provided as a fortification component coating disposed on a surface of a structure that is in fluid communication with the base inflation fluid, the fortified balloon inflation fluid including absorptive agents having an absorption maxima of greater than 10 nanometers and less than 2.5 micrometers, the step of expanding the balloon including the steps of providing the fortification component as the fortification component coating disposed on one of an inside surface of a balloon wall of the balloon and a surface of the elongate shaft that is in fluid communication with the base inflation fluid, providing the base inflation fluid to the balloon, and the base inflation fluid solvating the fortification component coating to form the fortified balloon inflation fluid; and

after expanding the balloon, activating a light source in optical communication with the light guide and the fortified balloon inflation fluid to provide sub-millisecond pulses of a light from the light source to the fortified balloon inflation fluid so that plasma formation and rapid bubble formation occur in the fortified balloon inflation fluid, thereby imparting pressure waves upon the treatment site.

12. The method of claim 11 wherein the fortification component comprises one of iron dextran and nanoparticles.

13. The method of claim 11 wherein the fortification component comprises nanoparticles, the nanoparticles including one of iron nanoparticles, gold nanoparticles, copper nanoparticles, carbon nanoparticles, carbon nanotubes, gold-coated carbon nanotubes, and copper-coated carbon nanotubes.

14. The method of claim 11 wherein the base inflation fluid includes saline and contrast medium in a ratio of saline to contrast medium of from 25:75 volume percent to 75:25 volume percent.

15. The method of claim 11 wherein the fortification component is configured to modify one of viscosity, density and surface tension of the fortified balloon inflation fluid compared to the base inflation fluid.

16. The method of claim 11 wherein the elongate shaft defines an inflation lumen, wherein the inflation lumen is in fluid communication with the balloon at a distal portion of the elongate shaft and in fluid communication with a fluid source at a proximal end of the elongate shaft.

17. The method of claim 11 wherein fortified balloon inflation fluid includes a contrast agent that includes one of diatrizoate, metrizoate, iothalamate, ioxaglate, iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol.

18. The method of claim 11 wherein the iron dextran is present in the fortified balloon inflation fluid at a concentration of from at least 0.0001 millimoles per liter (mmol/L) to 1.0 mmol/L.

19. The method of claim 11 wherein the first light guide comprises an optical fiber and wherein the light source comprises a laser.

20. A catheter system for imparting pressure to induce fractures at a treatment site within or adjacent a blood vessel wall, comprising:

a catheter configured to advance to the treatment site, the catheter comprising an elongate shaft and a balloon that is coupled to the elongate shaft, the balloon being configured to expand to a first expanded configuration suitable for anchoring the catheter in position relative to the treatment site;

a fortified balloon inflation fluid that is configured to expand the balloon to the first expanded configuration, the fortified balloon inflation fluid including a base inflation fluid and a fortification component, the fortification component being configured to reduce a threshold for inducing plasma formation in the fortified balloon inflation fluid compared to the base inflation fluid, wherein the fortification component comprises one of iron nanoparticles, gold nanoparticles, copper nanoparticles, carbon nanoparticles, carbon nanotubes, gold-coated carbon nanotubes, iron dextran, and copper-coated carbon nanotubes, and wherein the fortification component is provided as a fortification component coating disposed on a surface of a structure that is in fluid communication with the base inflation fluid; and

a first light guide that is disposed along the elongate shaft and at least partially within the balloon, the first light guide being configured to be in optical communication with a light source and the fortified balloon inflation fluid, the light source being configured to provide sub-millisecond pulses of a light to the first light guide so that plasma formation and rapid bubble formation occur in the fortified balloon inflation fluid, thereby imparting pressure waves upon the treatment site, the fortified balloon inflation fluid including absorptive agents having an absorption maxima of greater than 10 nanometers and less than 2.5 micrometers, the pressure waves having maximum pressures that are greater than 1 megapascal and less than 100 megapascals.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 27, 2025
From: BOLT MEDICAL, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 073266/0423 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 26, 2020
From: MASSIMINI, DANIEL FRANK; KRAUTKREMER, DANIEL LEE; SHAO, HAIPING; MCGOWAN, ROGER W.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 053048/0828 →
Continuity (5)
Provisional Application 62867026 · Jun 26, 2019
Provisional Application 62866981 · Jun 26, 2019
Provisional Application 62867009 · Jun 26, 2019
Provisional Application 62867034 · Jun 26, 2019
Related Publication 20200405333A1 · Dec 31, 2020
Cited By (1)
US 12,311,124