Shock wave catheter, electrode connection structure and control system

{
  "publication_number": "US2026102173A1",
  "country": "US",
  "kind": "A1",
  "title": "Shock wave catheter, electrode connection structure and control system",
  "abstract": "A shock wave catheter includes a catheter body including inner and outer tubes and a balloon connected to a distal end of the catheter body and provided thereon with a pressure sensor for monitoring a pressure profile within the balloon. The catheter body defines a fluid passage for introducing or discharging a medium into and from the balloon. A shock wave source is disposed on the inner tube to deliver pulses with energy according to the pressure profile. Through monitoring the pressure profile within the balloon during its operation using the pressure sensor disposed on the balloon, in the event of a rupture of the balloon due to some reason, the pressure sensor can quickly identify the abnormality, thereby effectively avoiding possible damage to a human body caused by otherwise continued electric discharge to the human body in the presence of the rupture in the balloon.",
  "claims": [
    "1. A shock wave catheter, comprising a balloon and a catheter body, wherein the balloon is connected to a distal end of the catheter body, the balloon provided thereon with at least one pressure sensor, the pressure sensor configured for detecting pressures at different locations on a surface of the balloon, which represent a pressure profile, and the catheter body comprising an outer tube and an inner tube the outer tube disposed over the inner tube, the catheter body defining a fluid passage configured for input and output of a medium into and from the balloon, the inner tube provided thereon with a shock wave source, the shock wave source configured for delivering pulses, wherein the pressure sensor transmits the pressures that it detects on the surface of the balloon to a control system the control system compares a change indicated by the pressures with a first predetermined threshold, if the change is greater than the first predetermined threshold, the control system deactivates the shock wave source and the shock wave source stops operating; when the pressure values that the control system receives are higher than a first predetermined pressure value, the control system controls the shock wave source to deliver pulses with less energy; when the pressure values are lower than a second predetermined pressure value, the control system controls the shock wave source to deliver pulses with more energy; when the pressure values are lower than a third predetermined pressure value, the control system generates an error report signal and stops output of pulses, the third predetermined pressure value is lower than the second predetermined pressure value; in response to every delivery of shock waves from the shock wave source, the pressure sensor collects a plurality of associated pressure values; the control system analyzes the plurality of pressure values, calculates changes indicated by pressure values associated with pulses delivered at a time interval spanning a predetermined number of times of delivery, and if the changes indicated by the pressure values are lower than a lower limit of a range, the control system adjusts an energy input with gradient; and the shock wave source comprises a plurality of sets of electrodes, which are wired in parallel and connected to a high-voltage generator. 2. The shock wave catheter according to claim 1, wherein a plurality of the pressure sensors are spaced apart on the balloon for pressure monitoring, at least one of the pressure sensors is aligned with a set of electrodes of the sets of electrodes in the shock wave source 3. The shock wave catheter according to claim 1, wherein each set of electrodes of the sets of electrodes in the shock wave source comprises a first electrode, a second electrode and an insulator layer, the first electrode embedded in the second electrode the insulator layer situated between the second electrode and the first electrode the second electrode and the insulator layer each defining a discharge aperture 4. The shock wave catheter according to claim 1, wherein each set of electrodes of the sets of electrodes in the shock wave source comprises a first electrode, a second electrode and an insulator layer, the first electrode and the second electrode arranged side by side, the insulator layer situated between the first electrode and the inner tube and between the second electrode and the inner tube, the first electrode and the second electrode defining a discharge aperture therebetween. 5. The shock wave catheter according to claim 1, wherein each set of electrodes of the sets of electrodes in the shock wave source comprises a first electrode, a second electrode and an insulator layer, the first electrode and the second electrode both embedded in the insulator layer, the first electrode and the second electrode on opposite sides of the inner tube, the insulator layer surrounded by an outer electrode disposed on the exterior thereof, the insulator layer and the outer electrode each defining a discharge aperture. 6. The shock wave catheter according to claim 1, wherein during crushing of calcific masses in a heavily calcified lesion, pressure values detected by the pressure sensor vary within a range, wherein if changes indicated by the pressure values are lower than a lower limit of a range, it is determined that the calcific masses have not been crushed yet, and the control system adjusts an energy input with gradient. 7. An electrode connection structure for use in the shock wave catheter according to claim 3, wherein the shock wave source comprises at least two or three sets of electrodes. 8. The electrode connection structure according to claim 7, wherein the shock wave source is composed of two sets of electrodes, the two sets of electrodes including a first set of electrodes and a second set of electrodes, the first set of electrodes and the second set of electrodes each comprise a first electrode and a second electrode, the first set of electrodes and the second set of electrodes are connected through the following connection manner: the first electrode in the first set of electrodes is wired to the first electrode in the second set of electrodes, the second electrode in the first set of electrodes is wired to the second electrode in the second set of electrodes and that both pairs are connected to the high-voltage generator. 9. The electrode connection structure according to claim 7, wherein the shock wave source is composed of three sets of electrodes, the three sets of electrodes including a first set of electrodes, a second set of electrodes and a third set of electrodes, wherein the first set of electrodes the second set of electrodes and the third set of electrodes each comprise a first electrode and a second electrode, the first set of electrodes, the second set of electrodes and the third set of electrodes are connected through the following connection manner: connection manner i: the first electrode in the first set of electrodes the first electrode in the second set of electrodes and the first electrode in the third set of electrodes are connected in parallel and then to the high-voltage generator and the second electrode in the first set of electrodes the second electrode in the second set of electrodes and the second electrode in the third set of electrodes are connected in parallel and then to the high-voltage generator, or connection manner ii: the first electrode in the first set of electrodes and the first electrode in the second set of electrodes are wired in parallel and then to the high-voltage generator, forming a first channel, the first electrode in the third set of electrodes is wired to the high-voltage generator, forming a second channel, the second electrode in the first set of electrodes, the second electrode in the second set of electrodes and the second electrode in the third set of electrodes are connected to the high-voltage generator and switching is able to be made from each of the first and second channels to the other for electric discharge. 10. A control system comprising: the shock wave catheter of claim 1; a data reception module for receiving pressure values from pressure sensors operating at different locations; a monitoring and analysis module for analyzing a pressure profile that the received pressure values represent and outputting a result of analysis; and an energy control module for generating a control signal based on the result of analysis, the control signal is used to adjust energy with which pulses are delivered from a shock wave source 11. The control system according to claim 10, wherein when a change indicated by the pressure values that the monitoring and analysis module receives exceeds a first predetermined threshold, the energy control module generates a power-off signal, the power-off signal is used to deactivate the shock wave source and stop its output of pulses. 12. The control system according to claim 10, wherein when the pressure values that the monitoring and analysis module receives are higher than a first predetermined pressure value, the energy control module controls the shock wave source to deliver pulses with less energy. 13. The control system according to claim 10, wherein when the pressure values that the monitoring and analysis module receives are lower than a second predetermined pressure value, the energy control module controls the shock wave source to deliver pulses with more energy. 14. The control system according to claim 10, wherein when the pressure values that the monitoring and analysis module receives are lower than a third predetermined pressure value, the energy control module generates an error report signal and stops output of the pulses, wherein the third predetermined pressure value is lower than a second predetermined pressure value. 15. The control system according to claim 10, wherein when a change indicated by the pressure values that the monitoring and analysis module receives is less than a second predetermined threshold, the energy control module controls the shock wave source to deliver pulses with more energy."
  ],
  "cpc": [
    "A61B 17/22022",
    "A61B 17/22029",
    "A61B 2017/00022",
    "A61B 2017/22025",
    "A61B 2017/22051",
    "A61B 2090/064",
    "G16H 40/63"
  ],
  "filing_date": "2024-04-17",
  "publication_date": "2026-04-16",
  "priority_date": "2023-06-06",
  "application_number": "US-202418862053-A"
}