# US 12,005,210 B2 · System for effecting and controlling oscillatory pressure within balloon catheters for fatigue fracture of calculi > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,210 B2 - Document ID: US12005210B2 - Status: Granted - Kind: B2 - Application number: 17/897,604 - Filed: 2022-08-29 - Published: 2022-12-29 - Granted: 2024-06-11 - Earliest claimed: 2018-04-12 - Assignees: The Regents of the University of Michigan - Applicants: The Regents of the University of Michigan - Inventors: Robert Chisena; Hitinder S. Gurm; Matthew Hildner; Yihao Zheng; Albert Shih - Web page: https://patentgrep.com/patent/US12005210B2 ## CPC - A61M 25/10182: {Injector syringes} - A61B 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)} - A61M 25/10184: {Means for controlling or monitoring inflation or deflation} - A61M 25/10185: {Valves} - A61B 2017/00017: {Electrical control of surgical instruments} - A61B 2017/00132: {Setting operation time of a device (A61B2017/00123 takes precedence)} - A61B 2017/00154: {pulsed} - A61B 2017/00181: {Means for setting or varying the pulse energy} - A61B 2017/00185: {Means for setting or varying the pulse height} - A61B 2017/00194: {Means for setting or varying the repetition rate} - A61B 2017/00539: {hydraulically} - A61B 2017/00548: {Gas cartridges therefor} - A61B 2017/22001: {Angioplasty, e.g. PCTA} - A61B 2017/22014: {the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire} - A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)} - A61B 2017/22062: {to be filled with liquid} - A61B 2017/22098: {Decalcification of valves} - A61M 25/10187: {Indicators for the level of inflation or deflation} - A61M 2205/3344: Measuring or controlling pressure at the body treatment site - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) The dynamic balloon angioplasty system according to claim 1, wherein the electrical power source is a voltage potential source. ### Claim 3 (depends on 1) The dynamic balloon angioplasty system according to claim 1, wherein the electrical power source is a current source. ### Claim 4 (depends on 1) 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. ### Claim 5 (depends on 1) The dynamic balloon angioplasty system according to claim 1, wherein the elongated catheter is configured to receive a guidewire. ### Claim 6 (depends on 5) The dynamic balloon angioplasty system according to claim 5, wherein the guidewire is a 0.014-inch guidewire. ### Claim 7 (depends on 1) 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. ### Claim 8 (depends on 7) The dynamic balloon angioplasty system according to claim 7, wherein the electromagnet surrounds the plunger. ### Claim 9 (depends on 8) The dynamic balloon angioplasty system according to claim 8, wherein the plunger is magnetic. ### Claim 10 (depends on 9) 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. ### Claim 11 (depends on 8) The dynamic balloon angioplasty system according to claim 8, wherein the plunger is ferromagnetic. ### Claim 12 (depends on 7) The dynamic balloon angioplasty system according to claim 7, wherein the elastic diaphragm is spring-loaded to accelerate depressurization of the angioplasty balloon. ### Claim 13 (depends on 7) The dynamic balloon angioplasty system according to claim 7, wherein the plunger is spring-loaded to accelerate depressurization of the angioplasty balloon. ### Claim 14 (depends on 1) 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. ### Claim 15 (depends on 14) 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. ### Claim 16 (depends on 15) 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. ### Claim 17 (depends on 15) 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. ### Claim 18 (depends on 15) 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. ### Claim 19 (depends on 14) 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. ### Claim 20 (depends on 14) 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. ### Claim 21 (depends on 14) 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. ### Claim 22 (depends on 14) 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. ### Claim 23 (depends on 14) 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. ### Claim 24 (depends on 1) The dynamic balloon angioplasty system according to claim 1, wherein the angioplasty inflation device is a lockable screw-piston-type syringe. ### Claim 25 (depends on 1) 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. ### Claim 26 (depends on 1) 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. ### Claim 27 (depends on 26) 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. ### Claim 28 (depends on 26) 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. ### Claim 29 (depends on 1) 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. ### Claim 30 (depends on 29) The dynamic balloon angioplasty system according to claim 29, wherein the pressure in the angioplasty balloon is predetermined. ### Claim 31 (depends on 29) 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. ### Claim 32 (depends on 1) The dynamic balloon angioplasty system according to claim 1, wherein the oscillating mechanism and/or the angioplasty balloon inflation device are configured to provide static pressure to the angioplasty balloon. ### Claim 33 (depends on 1) The dynamic balloon angioplasty system according to claim 1, wherein the oscillating mechanism and/or the angioplasty balloon inflation device are selectively fluidly coupled to the angioplasty balloon catheter. ### Claim 34 (depends on 1) The dynamic balloon angioplasty system according to claim 1, wherein the angioplasty unit is configured to generate pressure oscillations from zero or near zero pressure to at least a peak pressure at a frequency greater than or equal to an optimal hydraulic pressure oscillation frequency.