System for effecting and controlling oscillatory pressure within balloon catheters for fatigue fracture of calculi

Patent metadata

Field	Value
Publication number	US-12005210-B2
Application number	US-202217897604-A
Country	US
Kind code	B2
Filing date	Aug 29, 2022
Priority date	Apr 12, 2018
Publication date	Jun 11, 2024
Grant date	Jun 11, 2024

Abstract

A dynamic balloon angioplasty system for applying a dynamic pressure to fracture hardened materials embedded within an elastic conduit. The system having a pressure source system outputting at least a first predetermined pressure from a pressure source outlet, and an angioplasty unit fluidly coupled to the pressure source outlet receiving at least the first predetermined pressure. The angioplasty unit having an angioplasty inflation device, an angioplasty balloon connector, and an oscillating mechanism selectively actuated to output a plurality of pressure pulses to the angioplasty balloon via a fluid communication path. A control system is configured to determine an optimal hydraulic pressure oscillation frequency and amplitude for a given procedure and output a control signal to the oscillating mechanism, and monitor a pressure signal to detect fracture of the hardened material within the elastic conduit or system failure or leakage.

First claim

What is claimed is:

1. A dynamic balloon angioplasty system for applying pressure pulses or static pressure to an angioplasty balloon, the system comprising:
an angioplasty unit comprising an oscillating mechanism, an angioplasty balloon inflation device and a balloon connector,
wherein the oscillating mechanism comprises:
an electromagnet;
a diaphragm unit configured to translate relative to the electromagnet to generate pressure pulses or static pressure; and
a fluid output port fluidly coupled to the diaphragm unit, the angioplasty balloon inflation device and the balloon connector via a fluid communication path;

an electrical power source operably connected to the electromagnet and configured to selectively power the electromagnet to translate the diaphragm unit and output a plurality of pressure pulses or a static pressure through the fluid output port; and
an angioplasty balloon catheter fluidly coupled to the balloon connector and comprising an elongated catheter and an angioplasty balloon present at a distal end of the elongated catheter,
wherein the elongated catheter delivers the plurality of pressure pulses or static pressure to the angioplasty balloon.

2. The dynamic balloon angioplasty system according to claim 1 , wherein the electrical power source is a voltage potential source.

3. The dynamic balloon angioplasty system according to claim 1 , wherein the electrical power source is a current source.

4. The dynamic balloon angioplasty system according to claim 1 , wherein the electrical power source comprises a switching unit configured to selectively output electrical power from the electrical power source.

5. The dynamic balloon angioplasty system according to claim 1 , wherein the elongated catheter is configured to receive a guidewire.

6. The dynamic balloon angioplasty system according to claim 5 , wherein the guidewire is a 0.014-inch guidewire.

7. The dynamic balloon angioplasty system according to claim 1 , wherein the diaphragm unit comprises an elastic diaphragm, a distal fluid chamber enclosed by the elastic diaphragm and a plunger operably connected to the elastic diaphragm.

8. The dynamic balloon angioplasty system according to claim 7 , wherein the electromagnet surrounds the plunger.

9. The dynamic balloon angioplasty system according to claim 8 , wherein the plunger is magnetic.

10. The dynamic balloon angioplasty system according to claim 9 , wherein the electrical power source is configured to reverse a polarity of electrical power to the electromagnet to accelerate depressurization of the angioplasty balloon.

11. The dynamic balloon angioplasty system according to claim 8 , wherein the plunger is ferromagnetic.

12. The dynamic balloon angioplasty system according to claim 7 , wherein the elastic diaphragm is spring-loaded to accelerate depressurization of the angioplasty balloon.

13. The dynamic balloon angioplasty system according to claim 7 , wherein the plunger is spring-loaded to accelerate depressurization of the angioplasty balloon.

14. The dynamic balloon angioplasty system according to claim 1 , further comprising a control system operably connected to the electrical power source and configured to selectively activate the electrical power source.

15. The dynamic balloon angioplasty system according to claim 14 , wherein the angioplasty balloon catheter further comprises a pressure transducer that measures fluid pressure within the angioplasty balloon catheter and outputs a pressure signal to the control system.

16. The dynamic balloon angioplasty system according to claim 15 , wherein the control system is further configured to monitor the pressure signal to detect fracture of hardened material proximal to the angioplasty balloon by comparing pressure oscillations before and after the fracture, the pressure oscillations being at a lower average pressure after the fracture than before the fracture.

17. The dynamic balloon angioplasty system according to claim 15 , wherein the control system is further configured to determine an optimal hydraulic pressure oscillation frequency and optimal hydraulic pressure magnitude for a given procedure and output a control signal to the electrical power source.

18. The dynamic balloon angioplasty system according to claim 15 , wherein the control system is further configured to monitor the pressure signal to detect fracture or modification of hardened material proximal to the angioplasty balloon by determining an overall diminution of pressure due to an increase in volume of the angioplasty balloon.

19. The dynamic balloon angioplasty system according to claim 14 , wherein the control system is further configured to adjust an actuation frequency and/or a duty cycle of the oscillating mechanism.

20. The dynamic balloon angioplasty system according to claim 14 , wherein the control system is further configured to determine optimal actuation settings of the electrical power source.

21. The dynamic balloon angioplasty system according to claim 14 , wherein the control system is further configured to adjust the actuation frequency of the oscillating mechanism to previously determined optimal actuation settings.

22. The dynamic balloon angioplasty system according to claim 14 , wherein the control system is further configured to accept a user-defined peak pressure value to limit peak pressure within the angioplasty balloon.

23. The dynamic balloon angioplasty system according to claim 14 , wherein the control system is further configured to monitor the pressure signal to detect fracture of hardened material within an elastic conduit to which the angioplasty balloon is applied or system failure or leakage.

24. The dynamic balloon angioplasty system according to claim 1 , wherein the angioplasty inflation device is a lockable screw-piston-type syringe.

25. The dynamic balloon angioplasty system according to claim 1 , wherein the system is configured so the angioplasty balloon is inflated at a frequency of between 2 to 40 Hz.

26. The dynamic balloon angioplasty system according to claim 1 , wherein the system is configured so a peak pressure in the angioplasty balloon is substantially the same as the fluid pressure within the fluid communication path.

27. The dynamic balloon angioplasty system according to claim 26 , wherein the fluid output port, the fluid communication path, the balloon connector and the elongated catheter are configured to reduce flow resistance of delivering the plurality of pressure pulses to the angioplasty balloon.

28. The dynamic balloon angioplasty system according to claim 26 , wherein the elongated catheter comprises an expanded flow channel or a stiffened catheter shaft or a braided catheter shaft.

29. The dynamic balloon angioplasty system according to claim 1 , wherein the electrical power source outputs an electrical power output that generates a pressure in the angioplasty balloon.

30. The dynamic balloon angioplasty system according to claim 29 , wherein the pressure in the angioplasty balloon is predetermined.

31. The dynamic balloon angioplasty system according to claim 29 , wherein the pressure in the angioplasty balloon is ramped, stepped, oscillated, user-guided or pressure-transducer-feedback-guided.

32. The dynamic balloon angioplasty system according to claim 1 , wherein

Assignees

• Univ Michigan Regents

Inventors

• Chisena Robert
• Gurm Hitinder S
• Hildner Matthew
• Zheng Yihao
• Shih Albert

Classifications

• A61B2017/22098

  Decalcification of valves · CPC title

• A61B2017/00181

  Means for setting or varying the pulse energy · CPC title

• A61B2017/00539

  hydraulically · CPC title

• A61B2017/00154

  pulsed · CPC title

• A61B2017/22051

  with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence) · CPC title