Granted Patent B2

US 12,274,460 · App. 17/021,905 · Granted Apr 15, 2025

Inventors: Huy Phan (Santa Clara, CA); Hoa Nguyen (Santa Clara, CA); Chi Long (Santa Clara, CA); Todd Jenkins (Santa Clara, CA)

Assignee: SHOCKWAVE MEDICAL, INC.

A61B17/22004A61B2017/22001A61B2017/22044A61B2017/22045A61B2017/22067A61B2017/22071A61B2017/22094

Abstract

Claims (26)

1. A catheter for treating occlusions in blood vessels comprising:

a tubular guidewire sheath defining a plurality of lumens, the plurality of lumens comprising a first lumen for carrying a guidewire;

a shock wave generator located near a distal end of the catheter, said shock wave generator including at least one distal electrode pair, with electrodes of each pair being spaced apart to define at least one gap;

a first wire and a second wire, wherein proximal ends of the first wire and the second wire are connectable to a pulsed voltage source, and wherein distal ends of the first wire and the second wire are connected to the at least one distal electrode pair such that when high voltage pulses are applied across the first wire and the second wire, current flows across the at least one gap creating shock waves for treating an occlusion; and

a flexible cap formed from a material having elastomeric properties and sealably attached to the distal end of the catheter and surrounding the at least one distal electrode pair, said flexible cap being inflatable with conductive fluid such that the flexible cap expands to provide a space between an inner wall of the flexible cap and the at least one distal electrode pair and wherein when the flexible cap is in a deflated state, a surface area of the flexible cap is small enough that the flexible cap is not folded when the catheter is advanced into a blood vessel and when the flexible cap is in an inflated state a maximum diameter of the flexible cap is no more than 15% greater than a diameter of the flexible cap in the deflated state, with the maximum diameter of the flexible cap being independent of a size of the blood vessel, and wherein after being deflated, the flexible cap returns to a low profile configuration without folds.

2. The catheter of claim 1 , wherein the flexible cap comprises an angioplasty balloon.

3. The catheter of claim 1 , wherein the flexible cap comprises an extruded polymer tube.

4. The catheter of claim 1 , wherein the at least one distal electrode pair comprises a first electrode pair and a second electrode pair, wherein the first electrode pair comprises:

a conductive portion of the first wire; and

a conductive sheath wrapped circumferentially around the tubular guidewire sheath; and

wherein the second electrode pair comprises:

the conductive sheath; and

a conductive portion of the second wire.

5. The catheter of claim 1 , further comprising a third wire and a fourth wire extending within one or more lumens of the tubular guidewire sheath, wherein proximal ends of the third wire and fourth wire are connectable to the pulsed voltage source, and wherein distal ends of the third wire and the fourth wire are connected to at least one proximal electrode pair.

6. The catheter of claim 5 , wherein the at least one proximal electrode pair comprises a third electrode pair and a fourth electrode pair, wherein the third electrode pair comprises:

an insulation removed portion of the third wire; and

a further conductive sheath wrapped circumferentially around the tubular guidewire sheath; and

wherein the fourth electrode pair comprises:

the further conductive sheath; and

an insulation removed portion of the fourth wire.

7. The catheter of claim 5 , wherein the pulsed voltage source is controllable to apply the high voltage pulses across either the first wire and the second wire or the third wire and the fourth wire to create shock waves at either the at least one distal electrode pair or the at least one proximal electrode pair.

8. The catheter of claim 1 , wherein the tubular guidewire sheath defines one or more fluid lumens for carrying the conductive fluid between a proximal end of the catheter and the balloon.

9. The catheter of claim 1 , wherein at least a portion of the tubular guidewire sheath comprises spacing features protruding from an outer surface of the tubular guidewire sheath, wherein the spacing features are configured to maintain the inner wall of the flexible cap a controlled distance away from the outer surface of the guidewire sheath.

10. The catheter of claim 1 wherein when the flexible cap is in the inflated state, the maximum diameter of the flexible cap is no more than 10% greater than the diameter of the flexible cap in the deflated state.

11. The catheter of claim 1 , wherein the flexible cap is an extruded polymer tube.

12. The catheter of claim 1 , wherein the flexible cap is configured to expand to the maximum diameter when inflated by inflation pressures of up to six atmospheres.

Assignments (4)

Continuity (2)

References Cited (400)

Cited By (1)

US 12,708,382