Granted Patent B2

US 12,329,400 · App. 17/827,169 · Granted Jun 17, 2025

Inventors: Robert Chisena (Ann Arbor, MI); Hitinder Gurm (Ann Arbor, MI)

Assignee: Amplitude Vascular Systems, Inc.

A61B17/22012A61M5/007A61B2017/00022A61B2017/00039A61B2017/00477A61B2017/00964A61B2017/22001A61B2017/22038A61B2017/22054A61B2017/22062A61B2090/063A61B2090/064

Abstract

Claims (46)

1. A system for transmitting pulse energy through a fluidic passage of a catheter, the system comprising:

(a) first and second pulse generating assemblies, wherein each pulse-generating assembly comprises:

(i) a pulse generator; and

(ii) a proximal connector operably connected to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy;

(b) a catheter component comprising a fluidic passage, wherein the fluidic passage is operably positioned between the proximal connectors and a distal balloon and configured to propagate each second pulse energy from each proximal connector along the fluidic passage to the distal balloon; and

(c) a controller configured to independently control each of the first and second pulse generating assemblies.

2. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 1 , wherein each proximal connector comprises a proximal chamber and a distal chamber separated by a membrane.

3. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 2 , wherein the system is configured to produce a plurality of pressure pulses from the first and second pulse-generating assemblies having an amplitude that is selected based on treatment efficacy.

4. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 3 , wherein the system is further configured to assess treatment efficacy by volume change in the balloon.

5. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 4 , wherein the volume change in the balloon is determined by membrane position.

6. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 5 , further configured to assess vessel compliance.

7. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 6 , further configured to assess vessel compliance in real time during treatment.

8. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 7 , further configured to assess vessel compliance before and after treatment.

9. The system for transmitting pulse energy through a fluidic passage of a catheter system according to claim 8 , wherein system is further configured to assess treatment efficacy based on changes in vessel compliance.

10. A system for transmitting pulse energy through a plurality of fluidic passages, the system comprising:

(a) a pulse generator;

(b) a proximal connector operably connected to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy;

(c) a first fluidic passage configured to propagate the second pulse energy from the proximal connector each fluidic passage to a first distal balloon; and

(d) a second fluidic passage configured to propagate the second pulse energy from the proximal connector to a second distal balloon; and

(e) a controller configured to control an output of the pulse generator.

11. The system for transmitting pulse energy through a plurality of fluidic passages according to claim 10 , wherein the proximal connector comprises a proximal chamber and a distal chamber separated by a membrane.

12. The system for transmitting pulse energy through a plurality of fluidic passages according to claim 11 , wherein the proximal chamber is defined by a proximal flange and the distal chamber is defined by a distal flange.

13. The system for transmitting pulse energy through a plurality of fluidic passages according to claim 12 , wherein the distal flange comprises a distal port fluidically coupling the distal chamber with the plurality of fluidic passages.

14. The system for transmitting pulse energy through a plurality of fluidic passages according to claim 13 , wherein the proximal chamber comprises a gas and the distal chamber comprises a liquid.

15. The system for transmitting pulse energy through a plurality of fluidic passages according to claim 14 , wherein the proximal connector further comprises a pressure sensor operably coupled to the distal chamber.

16. The system for transmitting pulse energy through a plurality of fluidic passages according to claim 15 , wherein the proximal connector comprises a membrane positional sensor configured to detect changes in membrane position of the membrane.

17. A method comprising:

deploying a system so that a distal balloon of the system is adjacent to an internal luminal tissue location, the system comprising:

(a) first and second pulse generating assemblies, wherein each pulse-generating assembly comprises:

(i) a pulse generator; and

(ii) a proximal connector operably connected to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy;

(b) a catheter component comprising a fluidic passage, wherein the fluidic passage is operably positioned between the proximal connectors and a distal balloon and configured to propagate each second pulse energy from each proximal connector along the fluidic passage to the distal balloon; and

(c) a controller configured to independently control each of the first and second pulse generating assemblies; and

actuating the system to impart pulsatile energy to the internal luminal tissue location.

18. A method comprising:

deploying a system so that a first distal balloon and a second distal balloon of the system are adjacent to internal luminal tissue location locations, the system comprising:

(a) a pulse generator;

(b) a proximal connector operably connected to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy;

(c) a first fluidic passage configured to propagate the second pulse energy from the proximal connector to a first distal balloon; and

(d) a second fluidic passage configured to propagate the second pulse energy from the proximal connector to the second distal balloon; and

(e) a controller configured to control an output of the pulse generator; and

actuating the system to impart pulsatile energy to the internal luminal tissue locations.

19. A balloon catheter assembly comprising:

(a) a proximal connector operably connected to a pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy;

(b) a first fluidic passage configured to propagate the second pulse energy from the proximal connector to a first distal balloon; and

(c) a second fluidic passage configured to propagate the second pulse energy from the proximal connector to a second distal balloon.

Assignments (1)

Continuity (5)

References Cited (84)

Cited By (3)

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