Granted Patent B2

US 12,232,760 · App. 17/494,640 · Granted Feb 25, 2025

Inventors: Peter Schneider (Honolulu, HI); Robert M. Giasolli (Orange, CA)

Assignee: CAGENT VASCULAR, INC.

A61B17/320725A61B17/22A61M25/0082A61M25/104A61B17/205A61B2017/22061A61M2025/0096A61M2025/1086A61M2025/109

Abstract

Claims (29)

1. An intravascular device comprising:

an inner balloon configured to expand to create a plurality of microperforations in a vessel wall of a vessel, the inner balloon comprising a plurality of strips, each strip of the plurality of strips including a plurality of microperforators spaced apart along a surface of each strip, each strip extending along an outer surface of the inner balloon, wherein expanding the inner balloon forms cleavage lines or planes in an atherosclerotic plaque of the vessel wall,

wherein the inner balloon forms microperforations while leaving most of the surface of the atherosclerotic plaque intact, leading to less separation of the atherosclerotic plaque from the vessel wall,

an outer balloon disposed circumferentially around the inner balloon, wherein the inner balloon extends for a length beyond the outer balloon, wherein the plurality of microperforators extend through the outer balloon to form cleavage lines or planes in an atherosclerotic plaque of the vessel wall, wherein the plurality of microperforators are not configured to deliver a fluid from within the intravascular device out to the vessel.

2. The intravascular device of claim 1 , wherein the inner balloon is configured to be inflated at pressures less or equal to 4 atmospheres.

3. The intravascular device of claim 1 , wherein each strip comprises between 5 microperforators and 100 microperforators.

4. The intravascular device of claim 1 , wherein each microperforator extends a height from the strip between 0.05 mm and 1.0 mm.

5. The intravascular device of claim 1 , wherein the intravascular device is configured to improve dilation of a lumen of the vessel.

6. The intravascular device of claim 1 , wherein the inner balloon comprises three or four strips.

7. The intravascular device of claim 1 , wherein the intravascular device is configured to compress the atherosclerotic plaque.

8. The intravascular device of claim 1 , wherein the strips comprise a metal.

9. An intravascular device comprising:

an inner balloon configured to expand to create a plurality of microperforations in a vessel wall of a vessel, the inner balloon comprising a plurality of strips, each strip of the plurality of strips including a plurality of microperforators spaced apart along a surface of each strip, each strip extending along an outer surface of the inner balloon, wherein the inner balloon is configured to be inflated to press the plurality of microperforators into atherosclerotic plaque;

wherein the microperforations leave most of the surface of the atherosclerotic plaque intact, leading to less separation of the atherosclerotic plaque from the vessel wall, wherein the microperforations act as nucleation sites for void formation in an atherosclerotic plaque of the vessel wall, and

an outer balloon disposed over the plurality of strips in the spaces between microperforators, wherein the inner balloon extends for a length beyond the outer balloon, wherein the outer balloon is configured to stabilize and support the plurality of microperforators as the plurality of microperforators enter the plaque to cause microperforations, wherein the plurality of microperforators are not configured to deliver a fluid from within the intravascular device out to the vessel.

10. The intravascular device of claim 9 , wherein the plurality of microperforators are configured to be acutated by gas or fluid pressure.

11. The intravascular device of claim 9 , wherein the plurality of microperforators are configured to form tiny holes at specific prick points across the atherosclerotic plaque.

12. The intravascular device of claim 9 , wherein the intravascular device is configured to be reversibly expandable and collapsible within the vessel.

13. An intravascular device comprising:

an inner balloon configured to expand to create a plurality of microperforations in a vessel wall of a vessel, the inner balloon comprising a plurality of strips, each strip of the plurality of strips including a plurality of microperforators spaced apart along a surface of each strip, each strip extending along an outer surface of the inner balloon,

an outer balloon, wherein the inner balloon is sleeved inside the outer balloon, wherein the inner balloon extends for a length beyond the outer balloon, wherein the outer balloon comprises a plurality of holes aligned with the plurality of microperforators, wherein the plurality of microperforators extend through the plurality of holes to engage atherosclerotic plaque,

wherein the plurality of microperforators of the inner balloon form microperforations while leaving most of the surface of the atherosclerotic plaque intact, leading to less separation of the atherosclerotic plaque from the vessel wall, wherein stress energy for compressing the atherosclerotic plaque is released along the microperforations formed in the atherosclerotic plaque to control crack propagation, wherein the plurality of microperforators are not configured to deliver a fluid from within the intravascular device out to the vessel.

14. The intravascular device of claim 13 , wherein each strip is separated from adjacent strips.

15. The intravascular device of claim 13 , wherein each microperforator comprises an elongate top edge.

16. The intravascular device of claim 13 , wherein the inner balloon is configured to be deflated to disengage the plurality of microperforators from the atherosclerotic plaque.

17. The intravascular device of claim 1 , wherein the plurality of strips are bonded to the inner balloon.

18. The intravascular device of claim 9 , wherein the plurality of microperforators are arranged consistent with the fracture characteristics of the atherosclerotic plaque.

19. The intravascular device of claim 9 , wherein the plurality of microperforators are configured to create a cut-along-the-dotted-line serration.

20. The intravascular device of claim 13 , wherein the plurality of microperforators are arranged longitudinally.

Assignments (4)

Continuity (5)

References Cited (387)

Cited By (3)

US 12,594,406 US 12,642,946 US 12,714,836