US20200022716A1 - Method of managing energy delivered by a shockwave through dwell time compensation - Google Patents
Method of managing energy delivered by a shockwave through dwell time compensation Download PDFInfo
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- US20200022716A1 US20200022716A1 US16/554,497 US201916554497A US2020022716A1 US 20200022716 A1 US20200022716 A1 US 20200022716A1 US 201916554497 A US201916554497 A US 201916554497A US 2020022716 A1 US2020022716 A1 US 2020022716A1
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- A61B2017/22065—Functions of balloons
Definitions
- the present invention relates to a treatment system for percutaneous coronary angioplasty or peripheral angioplasty in which a dilation catheter is used to cross a lesion in order to dilate the lesion and restore normal blood flow in the artery. It is particularly useful when the lesion is a calcified lesion in the wall of the artery. Calcified lesions require high pressures (sometimes as high as 10-15 or even 30 atmospheres) to break the calcified plaque and push it back into the vessel wall. With such pressures comes trauma to the vessel wall which can contribute to vessel rebound, dissection, thrombus formation, and a high level of restenosis. Non-concentric calcified lesions can result in undue stress to the free wall of the vessel when exposed to high pressures.
- An angioplasty balloon when inflated to high pressures can have a specific maximum diameter to which it will expand but the opening in the vessel under a concentric lesion will typically be much smaller.
- the balloon will be confined to the size of the opening in the calcified lesion (before it is broken open).
- That energy is then released and results in the rapid expansion of the balloon to its maximum dimension and may stress and injure the vessel walls.
- Embodiments described therein include a catheter having balloon, such as an angioplasty balloon, at the distal end thereof arranged to be inflated with a fluid. Disposed within the balloon is a shock wave generator that may take the form of, for example, a pair of electrodes, which are coupled to a high voltage source at the proximal end of the catheter through a connector.
- a shock wave is formed that propagates through the fluid and impinges upon the wall of the balloon and the calcified region. Repeated pulses break up the calcium without damaging surrounding soft tissue.
- Each high voltage pulse causes an arc to form across the electrodes.
- the arc in turn causes a steam bubble to form.
- Each steam bubble has the potential of producing two shock waves, a leading edge shock wave as a result of bubble expansion and a trailing edge shock wave as a result of bubble collapse.
- the trailing edge shock waves exhibit highly variable energy levels and generally, much greater energy levels than the leading edge shock waves.
- the energy levels of the trailing edge shock waves are substantially dependent on the uniformity of the bubble collapse.
- the uniform collapse of spherical bubbles to a point appears to create the highest shock wave energies.
- spherical bubble configuration requires a substantially larger space than is available in a balloon that must fit into a calcified vein or artery or even a ureter.
- the trailing edge shock wave can be substantially eliminated by confining the bubble to an irregular shape.
- the trailing edge shock wave cannot be reliably relied upon to produce consistent results.
- leading edge shock waves formed by bubble expansion are a different matter. While exhibiting generally lower energies, they are more consistent in energy level. As a result, leading edge shock waves are good candidates for use in medical procedures such, for example, angioplasty or valvuloplasty.
- each high voltage pulse removes a portion of the electrode material. Since the size of the electrodes must be small in order to fit into the calcified vein or artery, they are only capable of sustaining a limited numbers of high voltage pulses sufficient to form the shock wave resulting electrical arc.
- a still further important aspect of prior art attempts to use shock waves from electrical arcs for therapeutic purposes is that from the time the high voltage is first applied to the electrodes to the time in which the arc occurs there is a dwell time (Td) that is highly variable from one high voltage application to the next.
- Td dwell time
- prior art strategies have relied upon high voltage applications where all high voltage pulse durations or pulse widths are of the same length and of a length sufficient to extend through the longest of the anticipated dwell times plus the associated arc and steam bubble.
- the dwell times are shorter than the maximum, the high voltage application durations are longer than necessary and can unnecessarily extend the arc and the steam bubble well beyond a time required to produce a shock wave of maximum intensity. The result is wasted energy, extended electrode erosion, and unnecessary heating of the adjoining tissue.
- a method for controlling the delivery of shock waves to treat calcified lesions in the wall of a blood vessel of a patient includes positioning an angioplasty catheter device within the blood vessel of the patient.
- the catheter device includes an angioplasty balloon surrounding an arc generator.
- the angioplasty catheter includes a central guide wire sheath for receiving a guide wire therein.
- the angioplasty balloon is inflated within the vessel with a conductive fluid.
- a plurality of voltage pulses from a power source are delivered to the arc generator disposed within the angioplasty balloon.
- the arc generator comprises a first electrode and a second electrode. During each pulse, signals representing values of a current flow between the first electrode and the second electrode are monitored by a current sensor.
- a switch When the current reaches a predetermined value, a switch is switched to disconnect the power source from the arc generator and terminate that voltage pulse.
- the energy in each voltage pulse is sufficient to ensure creation of a respective plasma arc by the arc generator, creating a respective expansion shock wave conducted through the conductive fluid and through the angioplasty balloon to the vessel, thereby delivering energy to the calcified lesions within a wall of the vessel to break apart the lesions.
- the predetermined value is selected to compensate for the variable dwell time between initial application of each pulse and creation of the respective plasma arc in order to minimize excess energy delivered to the arc generator.
- a method of delivering shock waves to treat calcified lesions incudes advancing an elongated carrier through a body lumen to reach the calcified lesion.
- the carrier includes a flexible member mounted near the distal end of the elongated carrier.
- a pair of electrodes are disposed within the flexible member.
- the flexible member is filled with a conductive fluid.
- a series of voltage pulses from a power source are delivered to the electrodes through a switch. Each voltage pulse has a voltage between 500 volts and 10,000 volts. Each pulse has sufficient energy to generate an arc in the fluid within the flexible member, allowing current to flow across the pair of electrodes to produce a shock wave associated with the expansion of a steam bubble.
- a dwell time between initial application of a given voltage pulse and creation of the arc is variable from pulse to pulse.
- the current flowing across the pair of electrodes is monitored.
- the predetermined value is selected to ensure the creation of the arc while compensating for the variable dwell time thereby minimizing excess energy delivered to the pair of electrodes.
- a method of delivering shock waves to treat calcified lesions in the wall of a blood vessel includes advancing an elongated angioplasty carrier through a blood vessel to reach the calcified lesion.
- the angioplasty carrier includes an angioplasty balloon mounted near the distal end of the angioplasty carrier.
- a pair of electrodes is disposed within the balloon.
- the balloon is filled with a conductive fluid.
- a series of voltage pulses from a power source are supplied to the electrodes through a switch, each voltage pulse having a voltage between 500 volts and 10,000 volts. Each voltage pulse has sufficient energy to generate an arc in the fluid within the balloon that allows current to flow across the pair of electrodes to produce a shock wave in the conductive fluid.
- a dwell time between initial application of a given voltage pulse and creation of the arc is variable from pulse to pulse.
- the current flowing across the pair of electrodes is monitored with a sensor during each voltage pulse.
- a delay period is initiated when the sensed current reaches a predetermined value. Once the delay period is over, the active voltage pulse is terminated by switching the switch.
- the predetermined value and the delay period are selected to ensure the creation of the arc while compensating for the variable dwell time thereby minimizing excess energy delivered to the pair of electrodes.
- a system in another embodiment, includes a catheter including an elongated carrier and a balloon about the carrier in sealed relation thereto.
- the balloon is arranged to receive a fluid therein that inflates the balloon.
- the catheter further includes first and second electrodes within the balloon arranged to receive there-across a high electrical voltage at an initial low current.
- the high electrical voltage causes an electrical arc to form across the first and second electrodes within the balloon.
- the electrical arc creates a gas bubble within the liquid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the balloon.
- the system further includes a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that terminates the high electrical voltage in response to the high current flow through the first and second electrodes.
- the power source includes a current sensor that senses current flowing through the first and second electrodes.
- the current sensor causes the power source to terminate the high electrical voltage when the current flowing through the first and second electrodes reaches a predetermined limit.
- the predetermined limit may be on the order of fifty amperes.
- the system may further include a temperature sensor within the balloon that senses temperature of the fluid within the balloon.
- the power source may be further responsive to the temperature sensor.
- the temperature sensor may cause the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to control the temperature of the fluid.
- the temperature sensor may cause the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to above two degrees Celsius above ambient temperature.
- Each pulse of the serial electrical high voltage pulses has an amplitude.
- the temperature sensor may cause the power source to decrease the energy applied to the first and second electrodes by decreasing the amplitude of the serial electrical high voltage pulses.
- the temperature sensor may cause the power source to decrease the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- the serial electrical high voltage pulses have a pulse rate.
- the temperature sensor may cause the power source to decrease the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- the balloon may be a dilation balloon.
- the dilation balloon may be an angioplasty balloon. In some applications, such as lithotripsy, a balloon may not be required.
- the system may further include a timer that times a delay time in response to the high current flow through the first and second electrodes and the power source may terminate the high electrical voltage after the delay time is timed.
- the power source may include a current sensor that senses current flowing through the first and second electrodes and the current sensor may cause the timer to time the delay time when the current flowing through the first and second electrodes reaches a predetermined limit.
- the predetermined limit may be on the order of fifty amperes.
- a system in another embodiment, includes a catheter including an elongated carrier having a guide wire lumen and a balloon having an inner surface about the carrier in sealed relation thereto.
- the balloon forms a channel with the carrier.
- the channel is arranged to receive a fluid that inflates the balloon.
- the catheter further includes first and second electrodes within the balloon, between the carrier and the inner surface of the balloon, arranged to receive there-across a high electrical voltage at an initial low current to cause an electrical arc to form across the first and second electrodes within the balloon.
- the electrical arc creates a gas bubble within the liquid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the balloon.
- the system further includes a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that terminates the high electrical voltage in response to the high current flow through the first and second electrodes.
- a system in a further embodiment, includes a catheter including an elongated carrier and a balloon about the carrier in sealed relation thereto.
- the balloon is arranged to receive a fluid therein that inflates the balloon.
- the catheter further includes first and second electrodes within the balloon arranged to receive there-across a high electrical voltage at an initial low current to cause an electrical arc to form across the first and second electrodes within the balloon.
- the electrical arc creates a steam bubble within the liquid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the balloon.
- the steam bubble increases the temperature of the fluid.
- the system further includes a temperature sensor within the balloon that senses temperature of the fluid within the balloon and a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that controls energy provided by the high electrical voltage in response to the sensed temperature of the fluid within the balloon.
- the temperature sensor causes the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to control the temperature of the fluid.
- the temperature sensor causes the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to about two degrees Celsius above ambient temperature.
- Each pulse of the serial electrical high voltage pulses has an amplitude.
- the temperature sensor may alternatively cause the power source to decrease the energy applied to the first and second electrodes by decreasing the amplitude of the serial electrical high voltage pulses.
- the temperature sensor may alternatively cause the power source to decrease the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- the serial electrical high voltage pulses have a pulse rate.
- the temperature sensor may alternatively cause the power source to decrease the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- the carrier of the catheter may have a guide wire lumen.
- the balloon has an inner surface that with the carrier, forms a channel arranged to receive the fluid that inflates the balloon.
- the first and second electrodes may be disposed between the carrier and the inner surface of the balloon.
- the invention provides a method that includes the steps of providing a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and first and second electrodes within the balloon.
- the method further includes introducing the fluid into the balloon to inflate the balloon, applying an electrical voltage across the first and second electrodes to form an electrical arc across the first and second electrodes, sensing current flow through the first and second electrodes, and varying the application of the electrical voltage across the first and second electrodes in response to sensed current flow through the first and second electrodes after the electrical arc is formed across the first and second electrodes.
- the varying step may include terminating the application of the electrical voltage across the first and second electrodes.
- the high electrical voltage may be terminated when the current flowing through the first and second electrodes reaches a predetermined limit.
- the predetermined limit may be on the order of fifty amperes.
- the method may include the further step of sensing temperature of the fluid within the balloon and the varying step may include varying the application of the electrical voltage across the first and second electrodes in response to sensed temperature of the fluid.
- the varying step may include decreasing energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to control the temperature of the fluid.
- the energy applied to the first and second electrodes may be decreased responsive to the temperature of the fluid within the balloon increasing to above two degrees Celsius above ambient temperature.
- the applying step may include applying energy in the form of serial electrical high voltage pulses and the varying step may further include decreasing the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- the serial electrical high voltage pulses have a pulse rate.
- the varying step may further include decreasing the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- the method may include the further step of timing a delay time in response to sensed current flow through the first and second electrodes and the varying step may include terminating the application of the electrical voltage across the first and second electrodes after timing the delay time.
- the delay time may be timed when the current flowing through the first and second electrodes reaches a predetermined limit.
- the predetermined limit may be on the order of fifty amperes.
- a method includes the steps of providing a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and first and second electrodes within the balloon.
- the method further includes the steps of introducing the fluid into the balloon to inflate the balloon, applying energy in the form of an electrical voltage across the first and second electrodes to form an electrical arc across the first and second electrodes, sensing temperature of the fluid within the balloon, and varying the application of the energy across the first and second electrodes in response to sensed temperature of the fluid within the balloon.
- the varying step may include decreasing the energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing.
- the varying step may include decreasing the energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to about two degrees Celsius above ambient temperature.
- Each pulse of the serial electrical high voltage pulses has an amplitude.
- the varying step may include decreasing the energy applied to the first and second electrodes by decreasing the amplitude of the serial electrical high voltage pulses.
- the applying step may include applying energy in the form of serial electrical high voltage pulses and the varying step may further include decreasing the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- the applying step may include applying energy in the form of serial electrical high voltage pulses, wherein the serial electrical high voltage pulses have a pulse rate.
- the varying step may further include decreasing the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- a system treats obstructions within bodily fluid and includes a catheter including first and second electrodes arranged to receive there-across a high electrical voltage at an initial low current.
- the high electrical voltage causes an electrical arc to form across the first and second electrodes.
- the electrical arc creates a gas bubble within the bodily fluid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the bodily fluid.
- the system further includes a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that terminates the high electrical voltage in response to the high current flow through the first and second electrodes.
- the energy applied by the power source may be in the form of serial electrical high voltage pulses. Each pulse of the serial electrical high voltage pulses has an amplitude.
- the power source may control the energy applied to the first and second electrodes by varying the amplitude of the serial electrical high voltage pulses.
- the serial electrical high voltage pulses have a pulse rate.
- the power source may vary the energy applied to the first and second electrodes by varying the pulse rate of the serial electrical high voltage pulses.
- the system may further include a timer that times a delay time in response to the high current flow through the first and second electrodes and the power source may terminate the high electrical voltage after the delay time is timed.
- the power source may include a current sensor that senses current flowing through the first and second electrodes and the current sensor may cause the timer to time the delay time when the current flowing through the first and second electrodes reaches a predetermined limit.
- the predetermined limit may be on the order of fifty amperes.
- a method includes the steps of providing a catheter including first and second electrodes, applying an electrical voltage across the first and second electrodes to form an electrical arc across the first and second electrodes, sensing current flow through the first and second electrodes, and varying the application of the electrical voltage across the first and second electrodes in response to sensed current flow through the first and second electrodes after the electrical arc is formed across the first and second electrodes.
- the applying step may include applying energy in the form of serial electrical high voltage pulses, the serial electrical high voltage pulses having a pulse rate, and wherein the varying step further includes controlling the energy applied to the first and second electrodes by varying the pulse rate of the serial electrical high voltage pulses.
- the serial high voltage pulses have amplitudes.
- the varying step may alternatively or in addition include controlling the energy applied to the first and second electrodes by varying the amplitude of the serial electrical high voltage pulses.
- the method may include the further step of timing a delay time in response to sensed current flow through the first and second electrodes and the varying step may include terminating the application of the electrical voltage across the first and second electrodes after timing the delay time.
- the delay time may be timed when the current flowing through the first and second electrodes reaches a predetermined limit.
- the predetermined limit may be on the order of fifty amperes.
- FIG. 1 is a simplified side view of an angioplasty balloon catheter of the type that may utilize various embodiments of the invention to advantage;
- FIG. 2 is a simplified side view of an electrode structure that may be employed in the catheter of FIG. 1 coupled to a source of high voltage pulses according to one embodiment of the invention
- FIG. 3 is a front plan view of the electrode structure of FIG. 2 ;
- FIG. 4 is a simplified equivalent circuit diagram of a system according to an embodiment of the invention.
- FIG. 5 is a graph illustrating a high voltage pulse applied to a pair of electrical arc shock wave producing electrodes and the resulting current flow through the electrodes in accordance with an embodiment of the invention
- FIG. 6 is a schematic diagram of a power source for use in an angioplasty electrical arc shock wave angioplasty catheter according to an embodiment of the invention
- FIG. 7 is a side view of a dilating catheter with an electrical arc producing electrode structure and a temperature probe therein according to aspects of the invention.
- FIG. 8 is a schematic diagram of an angioplasty catheter system according to further embodiments of the invention.
- FIG. 9 is a simplified side view, partly in section, of a further embodiment wherein a balloon is not required.
- FIG. 10 is a flow diagram illustrating a further embodiment of the invention.
- FIG. 1 is a simplified side view of an angioplasty balloon catheter 20 of the type that may utilize various embodiments of the invention to advantage.
- the catheter 20 includes an elongated carrier, such as a hollow sheath 21 , a dilating balloon 26 formed about the sheath 21 in sealed relation thereto and a guide wire member 28 to which the balloon is sealed at a seal 23 .
- the guide wire member has a longitudinal lumen 29 through which a guide wire (not shown) may be received for directing the catheter 20 to a desired location within a vein or artery, for example.
- the sheath 21 forms with the guide wire member 28 a channel 27 through which fluid, such as saline, may be admitted into the balloon to inflate the balloon.
- the channel 27 further permits the balloon 26 to be provided with an electrode pair 25 including electrodes 22 and 24 within the fluid filled balloon 26 .
- the electrodes 22 and 24 are attached to a source 40 of high voltage pulses.
- the electrodes 22 and 24 are coaxially disposed with electrode 22 being a center electrode and electrode 24 being a ring shaped electrode about electrode 22 .
- the center electrode 22 is coupled to a positive terminal 44 of source 40 and the ring electrode 24 is coupled to a negative terminal 46 of the source 40 .
- the electrodes 22 and 24 are formed of metal, such as stainless steel, and are maintained a controlled distance apart to allow a reproducible arc to form for a given applied voltage and current.
- the electrical arcs between electrodes 22 and 24 in the fluid are used to generate shock waves in the fluid.
- Each pulse of high voltage applied to the electrodes 22 and 24 forms an arc across the electrodes.
- the voltage pulses may have amplitudes as low as 500 volts, but preferably, the voltage amplitudes are in the range of 1000 volts to 10,000 volts
- the balloon 26 may be filled with water or saline in order to gently fix the balloon in the walls of the artery or vein, for example, in direct proximity with the calcified lesion.
- the fluid may also contain an x-ray contrast to permit fluoroscopic viewing of the catheter during use.
- the physician or operator can start applying the high voltage pulses to the electrodes to form the shock waves that crack the calcified plaque.
- shockwaves will be conducted through the fluid, through the balloon, through the blood and vessel wall to the calcified lesion where the energy will break the hardened plaque without the application of excessive pressure by the balloon on the walls of the artery.
- FIG. 4 is a simplified equivalent circuit diagram of a system according to an embodiment of the invention.
- a capacitance stores a high voltage.
- the voltage drop across the electrodes 22 and 24 begins to quickly rise at an initially low current level.
- an electrical arc occurs across the electrodes.
- the arc causes a steam bubble to form between the electrodes and a relatively high current to flow through the electrodes.
- the expansion of the bubble forms a first or leading edge shock wave.
- the steam bubble cools and condenses causing the bubble to collapse.
- the collapsing bubble has the potential for forming a second or trailing edge shock wave.
- the trailing edge shock wave is relatively unreliable exhibiting inconsistent intensities from shock wave to shock wave. Hence, it is the leading edge shock wave that holds the most promise for reliable therapy.
- shock wave intensity may be accomplished without holding the high voltage pulses on during the entire extent of their corresponding steam bubbles.
- terminating the application of the high voltage before steam bubble collapse can serve to preserve electrode material, permitting a pair of electrodes to last for an increased number of applied high voltage pulses.
- early termination of the high voltage can also be used to advantage in controlling the temperature within the balloon fluid.
- FIG. 5 is a graph illustrating a high voltage pulse applied to a pair of electrical arc shock wave producing electrodes and the resulting current flow through the electrodes in accordance with an embodiment of the invention.
- the switch 60 FIG. 4
- the voltage across the electrodes quickly rises to a level 70 .
- the current through the electrodes is relatively low.
- Td dwell time
- the arc occurs between the electrodes.
- the steam bubble begins to form and a high current begins to flow through the electrodes.
- the application of the high voltage is terminated.
- FIG. 6 is a schematic diagram of a power source 80 for use in an electrical arc shock wave angioplasty catheter according to an embodiment of the invention.
- the power source 80 has an output terminal 82 that may be coupled to electrode 22 of FIG. 1 and an output terminal 84 that may be coupled to electrode 24 of FIG. 1 .
- a switch circuit 86 selectively applies a high voltage on line 88 across the electrodes.
- a microprocessor 90 or other similar control circuitry, such as a gate array, controls the overall operation of the source 80 .
- a Field Programmable Gate Array (FPGA) may also be substituted for the microprocessor in a manner know in the art.
- the microprocessor 90 is coupled to the switch 86 by an optical driver 92 .
- the switch includes a current sensor 94 that includes a current sensing resistor 96 that generates a signal that is applied to an optical isolator 98 when the current flowing through the electrodes reaches a predetermined limit, such as, for example, fifty (50) amperes.
- the microprocessor 90 through the optical driver 92 , causes the switch 86 to apply the high voltage to the electrodes 22 and 24 .
- the current sensed through resister 96 is monitored by the microprocessor 90 through the optical isolator 98 .
- the microprocessor 90 causes the application of the high voltage to be terminated. The forgoing occurs for each high voltage pulse applied to the electrodes 22 and 24 . Each pulse creates a shock wave of consistent and useful intensity. Further, because the application of the high voltage is terminated early, the electrode material is preserved to lengthen the useful life of the electrodes.
- FIG. 7 is a side view of a dilating catheter with an electrical arc producing electrode structure and a temperature probe therein according to aspects of the invention.
- the catheter 20 of FIG. 7 may be the same catheter as shown in FIG. 1 .
- the catheter 20 further includes a temperature probe or sensor 100 .
- the temperature sensor may be employed for sensing the temperature of the fluid within the balloon.
- the temperature of the fluid within the balloon 26 should not be permitted to rise more than two degrees Celsius above the ambient body temperature. If this were to occur, soft tissue damage may result.
- FIG. 8 is a schematic diagram of an angioplasty catheter system 110 according to further embodiments of the invention which includes the catheter 20 and temperature probe 100 .
- the system also includes the microprocessor 90 , the switch 86 , optical driver 92 and optical isolator 98 . All of these elements may function as previously described.
- the temperature sensor 100 conveys a temperature signal through another optical isolator 120 indicative of the temperature of the fluid within the balloon 26 . If the temperature within the balloon 26 rises to more than a certain temperature, for example to more than two degrees Celsius above ambient body temperature, the energy applied to the electrodes is decreased. This will decrease the size and duration of the steam bubbles produced by the electrodes to maintain the temperature of the fluid within the balloon to within safe limits.
- the microprocessor 90 may cause the switch 86 to decrease the pulse amplitude of the applied high voltage pulses or the pulse rate of the applied high voltage pulse. It could alternatively temporarily terminate the application of the pulses.
- FIG. 9 is a simplified side view, partly in section, of a further embodiment wherein a balloon is not required.
- a system 134 is shown treating an obstruction, more particularly, a kidney stone 131 .
- the system includes a catheter 133 that terminates at its distal end with an electrode pair 132 similar to electrode pair 25 of FIGS. 1 and 2 .
- the system further includes a power source 140 .
- the power source has a positive output terminal 142 and a negative output terminal 144 .
- the center electrode of the electrode pair 132 may be coupled to the positive terminal 142 of source 140 and the ring electrode of the electrode pair 132 may be coupled to the negative terminal 144 of the source 140 .
- the electrodes of the electrode pair 132 may be formed of metal, such as stainless steel, and are maintained a controlled distance apart to allow a reproducible arc to form for a given applied voltage and current.
- the catheter 133 of system 134 is shown in a ureter 130 .
- the ureter has a kidney stone 131 requiring treatment.
- voltage pulses are applied to the electrode pair 132 to produce leading edge shock waves as previously described.
- the shock waves propagate through the fluid within the ureter and impinge directly on the kidney stone 131 .
- the power source may be operated to maintain the energy applied to the electrode pair within limits to assure that the steam bubbles produced by the generated arcs do not harm the ureter.
- the amplitude or pulse rate of the applied voltages may be controlled.
- the energy of the current during the produced arc such as by controlling the on time of the current, barotrauma to the ureter may be minimized even though a balloon is not employed as in previous embodiments.
- the system of FIG. 9 may be used in other body organs as well, such as the bile duct, for example.
- FIG. 10 is a flow diagram illustrating the process of a further embodiment of the invention.
- the embodiment of FIG. 10 takes into account the time it takes for a high voltage switch, such as switch 86 ( FIG. 6 ), to turn off (the turn off time) and the rise time of the current flowing through the electrodes once the electrical arc starts.
- the current through the electrodes can eventually reach one-hundred amperes or more, at which point the maximum intensity shock wave will be formed.
- a delay is timed extending from when the current flowing through the electrodes is at a fixed threshold known to be below the maximum current, to the turn off time of the switch before the expected current maximum.
- the current threshold may be fifty amperes.
- the delay timing is begun by the starting of a delay timer within the microprocessor 90 . If the current is expected to be at a maximum 200 nanoseconds after the current reaches fifty amperes, and if it takes 100 nanoseconds for the high voltage switch to actually turn off after receiving a turn off signal, a delay of 100 nanoseconds should be timed from the 50 ampere sensing before a turn off signal is applied to the high voltage switch. Hence, a total time of 200 nanoseconds will pass after the current reaches 50 amperes and, as a result, will reach its maximum. As the current reaches its maximum, or shortly thereafter, the voltage applied to the electrodes will be terminated.
- the process begins with activity step 202 wherein the high voltage is applied to the output terminals 82 and 84 for application to the electrodes, for example, electrodes 22 and 24 ( FIG. 1 ).
- the current initially flowing through the electrodes is relatively low.
- the applied high voltage causes an electrical arc to begin to form between the electrodes, the current through the electrodes is sensed, and the current rapidly rises.
- the current through the electrodes is sensed as previously described.
- the microprocessor 90 determines if the sensed current has reached fifty amperes.
- the process advances to activity block 206 where the timing of the aforementioned delay time (x) is started.
- decision block 208 it is determined when the delay time has been timed.
- the delay time (x) may be 100 nanoseconds.
- the process advances to activity block 210 wherein the process completes with a turn off signal being applied by the microprocessor 90 to the high voltage switch 86 .
- the switch 86 will actually turn of a turn of time after the turn off signal is applied to the switch 86 .
- a maximum intensity shock wave is formed without wasting energy, without unduly eroding the electrodes, and without generating unnecessary heat.
- the delay timing may be employed to advantage in each of the embodiments disclosed herein including the embodiment of FIG. 9 which does not require a balloon.
- the subject method can be used with various electrode designs.
- the electrodes can be provided with a low profile to improve the ability of the catheter to navigate small vessels.
- An example of such a low profile electrode design can be found in U.S. Pat. No. 8,747,416.
- An example of an approach for alternating the polarity of the voltage pulses can be found in U.S. Pat. No. 10,226,265.
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Abstract
Description
- This application is a continuation-in-part of U.S. patent application Ser. No. 16/222,679, filed Dec. 17, 2018, which is a continuation of application of U.S. application Ser. No. 15/065,607, filed Mar. 9, 2016, issued as U.S. Pat. No. 10/159,505 on Dec. 25, 2018, which is a continuation of U.S. application Ser. No. 13/615,107, filed Sep. 13, 2012, issued as U.S. Pat. No. 9,333,000 on May 10, 2016 both entitled SHOCKWAVE CATHETER SYSTEM WITH ENERGY CONTROL, and each of which is hereby incorporated by reference in their entirety for all purposes.
- The present invention relates to a treatment system for percutaneous coronary angioplasty or peripheral angioplasty in which a dilation catheter is used to cross a lesion in order to dilate the lesion and restore normal blood flow in the artery. It is particularly useful when the lesion is a calcified lesion in the wall of the artery. Calcified lesions require high pressures (sometimes as high as 10-15 or even 30 atmospheres) to break the calcified plaque and push it back into the vessel wall. With such pressures comes trauma to the vessel wall which can contribute to vessel rebound, dissection, thrombus formation, and a high level of restenosis. Non-concentric calcified lesions can result in undue stress to the free wall of the vessel when exposed to high pressures. An angioplasty balloon when inflated to high pressures can have a specific maximum diameter to which it will expand but the opening in the vessel under a concentric lesion will typically be much smaller. As the pressure is increased to open the passage way for blood the balloon will be confined to the size of the opening in the calcified lesion (before it is broken open). As the pressure builds a tremendous amount of energy is stored in the balloon until the calcified lesion breaks or cracks. That energy is then released and results in the rapid expansion of the balloon to its maximum dimension and may stress and injure the vessel walls.
- Recently, a new system and method has been contemplated for breaking up calcium deposits in, for example, arteries and veins. Such a system is described, for example in U.S. Patent Publication No. 2009/0312768, Published Dec. 17, 2009. Embodiments described therein include a catheter having balloon, such as an angioplasty balloon, at the distal end thereof arranged to be inflated with a fluid. Disposed within the balloon is a shock wave generator that may take the form of, for example, a pair of electrodes, which are coupled to a high voltage source at the proximal end of the catheter through a connector. When the balloon is placed adjacent a calcified region of a vein or artery and a high voltage pulse is applied across the electrodes, a shock wave is formed that propagates through the fluid and impinges upon the wall of the balloon and the calcified region. Repeated pulses break up the calcium without damaging surrounding soft tissue.
- Each high voltage pulse causes an arc to form across the electrodes. The arc in turn causes a steam bubble to form. Each steam bubble has the potential of producing two shock waves, a leading edge shock wave as a result of bubble expansion and a trailing edge shock wave as a result of bubble collapse. The trailing edge shock waves exhibit highly variable energy levels and generally, much greater energy levels than the leading edge shock waves. The energy levels of the trailing edge shock waves are substantially dependent on the uniformity of the bubble collapse. The uniform collapse of spherical bubbles to a point appears to create the highest shock wave energies. Unfortunately, spherical bubble configuration requires a substantially larger space than is available in a balloon that must fit into a calcified vein or artery or even a ureter. In fact, the trailing edge shock wave can be substantially eliminated by confining the bubble to an irregular shape. As a result, for angioplasty or other cardiac and non-cardiac applications of shock waves, the trailing edge shock wave cannot be reliably relied upon to produce consistent results.
- However, the leading edge shock waves formed by bubble expansion are a different matter. While exhibiting generally lower energies, they are more consistent in energy level. As a result, leading edge shock waves are good candidates for use in medical procedures such, for example, angioplasty or valvuloplasty.
- Another consideration is the amount of energy represented by the high voltage applied to the electrodes. Each high voltage pulse removes a portion of the electrode material. Since the size of the electrodes must be small in order to fit into the calcified vein or artery, they are only capable of sustaining a limited numbers of high voltage pulses sufficient to form the shock wave resulting electrical arc.
- Also, it has been learned that to sustain a leading edge shock wave, it is not necessary to sustain the high voltage throughout the shock wave. Sustaining the high voltage beyond some point after the initial arc does not lead to shock waves of any greater intensity. Further, since the bubbles are formed of steam, the steam produces heat which can increase the temperature of adjacent soft tissue. Just a two degree Celsius elevation in temperature above body temperature can result in tissue damage.
- A still further important aspect of prior art attempts to use shock waves from electrical arcs for therapeutic purposes is that from the time the high voltage is first applied to the electrodes to the time in which the arc occurs there is a dwell time (Td) that is highly variable from one high voltage application to the next. To account for the dwell times that are long, prior art strategies have relied upon high voltage applications where all high voltage pulse durations or pulse widths are of the same length and of a length sufficient to extend through the longest of the anticipated dwell times plus the associated arc and steam bubble. As a result, when the dwell times are shorter than the maximum, the high voltage application durations are longer than necessary and can unnecessarily extend the arc and the steam bubble well beyond a time required to produce a shock wave of maximum intensity. The result is wasted energy, extended electrode erosion, and unnecessary heating of the adjoining tissue.
- Hence, there is a need in the art to be able to control the energy applied to the electrodes of an electrical arc shock wave generator. More particularly, there is a need to control the applied energy to assure appropriate bubble and shock wave formation while at the same time conserving electrode material and assuring tissue safety. The present invention addresses these and other issues.
- In one embodiment, a method for controlling the delivery of shock waves to treat calcified lesions in the wall of a blood vessel of a patient is disclosed. The method includes positioning an angioplasty catheter device within the blood vessel of the patient. The catheter device includes an angioplasty balloon surrounding an arc generator. The angioplasty catheter includes a central guide wire sheath for receiving a guide wire therein. The angioplasty balloon is inflated within the vessel with a conductive fluid. A plurality of voltage pulses from a power source are delivered to the arc generator disposed within the angioplasty balloon. The arc generator comprises a first electrode and a second electrode. During each pulse, signals representing values of a current flow between the first electrode and the second electrode are monitored by a current sensor. When the current reaches a predetermined value, a switch is switched to disconnect the power source from the arc generator and terminate that voltage pulse. The energy in each voltage pulse is sufficient to ensure creation of a respective plasma arc by the arc generator, creating a respective expansion shock wave conducted through the conductive fluid and through the angioplasty balloon to the vessel, thereby delivering energy to the calcified lesions within a wall of the vessel to break apart the lesions. The predetermined value is selected to compensate for the variable dwell time between initial application of each pulse and creation of the respective plasma arc in order to minimize excess energy delivered to the arc generator.
- In another embodiment, a method of delivering shock waves to treat calcified lesions is disclosed. The method incudes advancing an elongated carrier through a body lumen to reach the calcified lesion. The carrier includes a flexible member mounted near the distal end of the elongated carrier. A pair of electrodes are disposed within the flexible member. The flexible member is filled with a conductive fluid. A series of voltage pulses from a power source are delivered to the electrodes through a switch. Each voltage pulse has a voltage between 500 volts and 10,000 volts. Each pulse has sufficient energy to generate an arc in the fluid within the flexible member, allowing current to flow across the pair of electrodes to produce a shock wave associated with the expansion of a steam bubble. A dwell time between initial application of a given voltage pulse and creation of the arc is variable from pulse to pulse. During each voltage pulse, the current flowing across the pair of electrodes is monitored. When the sensed current reaches a predetermined value for a given pulse, that pulse is terminated using the switch. The predetermined value is selected to ensure the creation of the arc while compensating for the variable dwell time thereby minimizing excess energy delivered to the pair of electrodes.
- In another embodiment, a method of delivering shock waves to treat calcified lesions in the wall of a blood vessel is disclosed. The method includes advancing an elongated angioplasty carrier through a blood vessel to reach the calcified lesion. The angioplasty carrier includes an angioplasty balloon mounted near the distal end of the angioplasty carrier. A pair of electrodes is disposed within the balloon. The balloon is filled with a conductive fluid. A series of voltage pulses from a power source are supplied to the electrodes through a switch, each voltage pulse having a voltage between 500 volts and 10,000 volts. Each voltage pulse has sufficient energy to generate an arc in the fluid within the balloon that allows current to flow across the pair of electrodes to produce a shock wave in the conductive fluid. A dwell time between initial application of a given voltage pulse and creation of the arc is variable from pulse to pulse. The current flowing across the pair of electrodes is monitored with a sensor during each voltage pulse. For each given voltage pulse, a delay period is initiated when the sensed current reaches a predetermined value. Once the delay period is over, the active voltage pulse is terminated by switching the switch. The predetermined value and the delay period are selected to ensure the creation of the arc while compensating for the variable dwell time thereby minimizing excess energy delivered to the pair of electrodes.
- In another embodiment, a system includes a catheter including an elongated carrier and a balloon about the carrier in sealed relation thereto. The balloon is arranged to receive a fluid therein that inflates the balloon. The catheter further includes first and second electrodes within the balloon arranged to receive there-across a high electrical voltage at an initial low current. The high electrical voltage causes an electrical arc to form across the first and second electrodes within the balloon. The electrical arc creates a gas bubble within the liquid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the balloon. The system further includes a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that terminates the high electrical voltage in response to the high current flow through the first and second electrodes.
- The power source includes a current sensor that senses current flowing through the first and second electrodes. The current sensor causes the power source to terminate the high electrical voltage when the current flowing through the first and second electrodes reaches a predetermined limit. The predetermined limit may be on the order of fifty amperes.
- The system may further include a temperature sensor within the balloon that senses temperature of the fluid within the balloon. The power source may be further responsive to the temperature sensor.
- The temperature sensor may cause the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to control the temperature of the fluid. The temperature sensor may cause the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to above two degrees Celsius above ambient temperature.
- Each pulse of the serial electrical high voltage pulses has an amplitude. The temperature sensor may cause the power source to decrease the energy applied to the first and second electrodes by decreasing the amplitude of the serial electrical high voltage pulses. Alternatively, the temperature sensor may cause the power source to decrease the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- The serial electrical high voltage pulses have a pulse rate. The temperature sensor may cause the power source to decrease the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- The balloon may be a dilation balloon. The dilation balloon may be an angioplasty balloon. In some applications, such as lithotripsy, a balloon may not be required.
- The system may further include a timer that times a delay time in response to the high current flow through the first and second electrodes and the power source may terminate the high electrical voltage after the delay time is timed. The power source may include a current sensor that senses current flowing through the first and second electrodes and the current sensor may cause the timer to time the delay time when the current flowing through the first and second electrodes reaches a predetermined limit. The predetermined limit may be on the order of fifty amperes.
- In another embodiment, a system includes a catheter including an elongated carrier having a guide wire lumen and a balloon having an inner surface about the carrier in sealed relation thereto. The balloon forms a channel with the carrier. The channel is arranged to receive a fluid that inflates the balloon. The catheter further includes first and second electrodes within the balloon, between the carrier and the inner surface of the balloon, arranged to receive there-across a high electrical voltage at an initial low current to cause an electrical arc to form across the first and second electrodes within the balloon. The electrical arc creates a gas bubble within the liquid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the balloon. The system further includes a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that terminates the high electrical voltage in response to the high current flow through the first and second electrodes.
- In a further embodiment, a system includes a catheter including an elongated carrier and a balloon about the carrier in sealed relation thereto. The balloon is arranged to receive a fluid therein that inflates the balloon. The catheter further includes first and second electrodes within the balloon arranged to receive there-across a high electrical voltage at an initial low current to cause an electrical arc to form across the first and second electrodes within the balloon. The electrical arc creates a steam bubble within the liquid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the balloon. The steam bubble increases the temperature of the fluid. The system further includes a temperature sensor within the balloon that senses temperature of the fluid within the balloon and a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that controls energy provided by the high electrical voltage in response to the sensed temperature of the fluid within the balloon.
- The temperature sensor causes the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to control the temperature of the fluid. The temperature sensor causes the power source to decrease energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to about two degrees Celsius above ambient temperature.
- Each pulse of the serial electrical high voltage pulses has an amplitude. The temperature sensor may alternatively cause the power source to decrease the energy applied to the first and second electrodes by decreasing the amplitude of the serial electrical high voltage pulses. The temperature sensor may alternatively cause the power source to decrease the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- The serial electrical high voltage pulses have a pulse rate. The temperature sensor may alternatively cause the power source to decrease the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- The carrier of the catheter may have a guide wire lumen. The balloon has an inner surface that with the carrier, forms a channel arranged to receive the fluid that inflates the balloon. The first and second electrodes may be disposed between the carrier and the inner surface of the balloon.
- According to a further embodiment, the invention provides a method that includes the steps of providing a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and first and second electrodes within the balloon. The method further includes introducing the fluid into the balloon to inflate the balloon, applying an electrical voltage across the first and second electrodes to form an electrical arc across the first and second electrodes, sensing current flow through the first and second electrodes, and varying the application of the electrical voltage across the first and second electrodes in response to sensed current flow through the first and second electrodes after the electrical arc is formed across the first and second electrodes.
- The varying step may include terminating the application of the electrical voltage across the first and second electrodes. The high electrical voltage may be terminated when the current flowing through the first and second electrodes reaches a predetermined limit. The predetermined limit may be on the order of fifty amperes.
- The method may include the further step of sensing temperature of the fluid within the balloon and the varying step may include varying the application of the electrical voltage across the first and second electrodes in response to sensed temperature of the fluid.
- The varying step may include decreasing energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to control the temperature of the fluid. The energy applied to the first and second electrodes may be decreased responsive to the temperature of the fluid within the balloon increasing to above two degrees Celsius above ambient temperature.
- The applying step may include applying energy in the form of serial electrical high voltage pulses and the varying step may further include decreasing the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- The serial electrical high voltage pulses have a pulse rate. Alternatively, the varying step may further include decreasing the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- The method may include the further step of timing a delay time in response to sensed current flow through the first and second electrodes and the varying step may include terminating the application of the electrical voltage across the first and second electrodes after timing the delay time. The delay time may be timed when the current flowing through the first and second electrodes reaches a predetermined limit. The predetermined limit may be on the order of fifty amperes.
- According to another embodiment, a method includes the steps of providing a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and first and second electrodes within the balloon. The method further includes the steps of introducing the fluid into the balloon to inflate the balloon, applying energy in the form of an electrical voltage across the first and second electrodes to form an electrical arc across the first and second electrodes, sensing temperature of the fluid within the balloon, and varying the application of the energy across the first and second electrodes in response to sensed temperature of the fluid within the balloon.
- The varying step may include decreasing the energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing. The varying step may include decreasing the energy applied to the first and second electrodes responsive to the temperature of the fluid within the balloon increasing to about two degrees Celsius above ambient temperature.
- Each pulse of the serial electrical high voltage pulses has an amplitude. The varying step may include decreasing the energy applied to the first and second electrodes by decreasing the amplitude of the serial electrical high voltage pulses.
- The applying step may include applying energy in the form of serial electrical high voltage pulses and the varying step may further include decreasing the energy applied to the first and second electrodes by temporarily terminating the serial electrical high voltage pulses.
- The applying step may include applying energy in the form of serial electrical high voltage pulses, wherein the serial electrical high voltage pulses have a pulse rate. The varying step may further include decreasing the energy applied to the first and second electrodes by decreasing the pulse rate of the serial electrical high voltage pulses.
- In a still further embodiment, a system treats obstructions within bodily fluid and includes a catheter including first and second electrodes arranged to receive there-across a high electrical voltage at an initial low current. The high electrical voltage causes an electrical arc to form across the first and second electrodes. The electrical arc creates a gas bubble within the bodily fluid, a high current to flow through the first and second electrodes, and a mechanical shock wave within the bodily fluid. The system further includes a power source that provides the first and second electrodes with the high electrical voltage at the initial current and that terminates the high electrical voltage in response to the high current flow through the first and second electrodes.
- The energy applied by the power source may be in the form of serial electrical high voltage pulses. Each pulse of the serial electrical high voltage pulses has an amplitude. The power source may control the energy applied to the first and second electrodes by varying the amplitude of the serial electrical high voltage pulses.
- The serial electrical high voltage pulses have a pulse rate. Alternatively, the power source may vary the energy applied to the first and second electrodes by varying the pulse rate of the serial electrical high voltage pulses.
- The system may further include a timer that times a delay time in response to the high current flow through the first and second electrodes and the power source may terminate the high electrical voltage after the delay time is timed. The power source may include a current sensor that senses current flowing through the first and second electrodes and the current sensor may cause the timer to time the delay time when the current flowing through the first and second electrodes reaches a predetermined limit. The predetermined limit may be on the order of fifty amperes.
- In still a further embodiment, a method includes the steps of providing a catheter including first and second electrodes, applying an electrical voltage across the first and second electrodes to form an electrical arc across the first and second electrodes, sensing current flow through the first and second electrodes, and varying the application of the electrical voltage across the first and second electrodes in response to sensed current flow through the first and second electrodes after the electrical arc is formed across the first and second electrodes.
- The applying step may include applying energy in the form of serial electrical high voltage pulses, the serial electrical high voltage pulses having a pulse rate, and wherein the varying step further includes controlling the energy applied to the first and second electrodes by varying the pulse rate of the serial electrical high voltage pulses.
- The serial high voltage pulses have amplitudes. The varying step may alternatively or in addition include controlling the energy applied to the first and second electrodes by varying the amplitude of the serial electrical high voltage pulses.
- The method may include the further step of timing a delay time in response to sensed current flow through the first and second electrodes and the varying step may include terminating the application of the electrical voltage across the first and second electrodes after timing the delay time. The delay time may be timed when the current flowing through the first and second electrodes reaches a predetermined limit. The predetermined limit may be on the order of fifty amperes.
- The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:
-
FIG. 1 is a simplified side view of an angioplasty balloon catheter of the type that may utilize various embodiments of the invention to advantage; -
FIG. 2 is a simplified side view of an electrode structure that may be employed in the catheter ofFIG. 1 coupled to a source of high voltage pulses according to one embodiment of the invention; -
FIG. 3 is a front plan view of the electrode structure ofFIG. 2 ; -
FIG. 4 is a simplified equivalent circuit diagram of a system according to an embodiment of the invention; -
FIG. 5 is a graph illustrating a high voltage pulse applied to a pair of electrical arc shock wave producing electrodes and the resulting current flow through the electrodes in accordance with an embodiment of the invention; -
FIG. 6 is a schematic diagram of a power source for use in an angioplasty electrical arc shock wave angioplasty catheter according to an embodiment of the invention; -
FIG. 7 is a side view of a dilating catheter with an electrical arc producing electrode structure and a temperature probe therein according to aspects of the invention; -
FIG. 8 is a schematic diagram of an angioplasty catheter system according to further embodiments of the invention; -
FIG. 9 is a simplified side view, partly in section, of a further embodiment wherein a balloon is not required; and -
FIG. 10 is a flow diagram illustrating a further embodiment of the invention. -
FIG. 1 is a simplified side view of anangioplasty balloon catheter 20 of the type that may utilize various embodiments of the invention to advantage. Thecatheter 20 includes an elongated carrier, such as ahollow sheath 21, a dilatingballoon 26 formed about thesheath 21 in sealed relation thereto and aguide wire member 28 to which the balloon is sealed at aseal 23. The guide wire member has a longitudinal lumen 29 through which a guide wire (not shown) may be received for directing thecatheter 20 to a desired location within a vein or artery, for example. - The
sheath 21 forms with the guide wire member 28 achannel 27 through which fluid, such as saline, may be admitted into the balloon to inflate the balloon. Thechannel 27 further permits theballoon 26 to be provided with anelectrode pair 25 includingelectrodes balloon 26. - As may be seen in
FIG. 2 , theelectrodes source 40 of high voltage pulses. As may be seen inFIG. 3 , theelectrodes electrode 22 being a center electrode andelectrode 24 being a ring shaped electrode aboutelectrode 22. Thecenter electrode 22 is coupled to apositive terminal 44 ofsource 40 and thering electrode 24 is coupled to a negative terminal 46 of thesource 40. Theelectrodes - The electrical arcs between
electrodes electrodes balloon 26 may be filled with water or saline in order to gently fix the balloon in the walls of the artery or vein, for example, in direct proximity with the calcified lesion. The fluid may also contain an x-ray contrast to permit fluoroscopic viewing of the catheter during use. Once thecatheter 20 is positioned with the guide wire (not shown), the physician or operator can start applying the high voltage pulses to the electrodes to form the shock waves that crack the calcified plaque. Such shockwaves will be conducted through the fluid, through the balloon, through the blood and vessel wall to the calcified lesion where the energy will break the hardened plaque without the application of excessive pressure by the balloon on the walls of the artery. -
FIG. 4 is a simplified equivalent circuit diagram of a system according to an embodiment of the invention. Here it may be seen that a capacitance stores a high voltage. When aswitch 60 is closed, the voltage drop across theelectrodes - It has been found that effective shock wave intensity may be accomplished without holding the high voltage pulses on during the entire extent of their corresponding steam bubbles. Moreover, terminating the application of the high voltage before steam bubble collapse can serve to preserve electrode material, permitting a pair of electrodes to last for an increased number of applied high voltage pulses. Still further, as will be seen subsequently, early termination of the high voltage can also be used to advantage in controlling the temperature within the balloon fluid.
-
FIG. 5 is a graph illustrating a high voltage pulse applied to a pair of electrical arc shock wave producing electrodes and the resulting current flow through the electrodes in accordance with an embodiment of the invention. When the switch 60 (FIG. 4 ) is first closed, the voltage across the electrodes quickly rises to alevel 70. During this time, as shown by dashedlines 72, the current through the electrodes is relatively low. After a dwell time (Td), the arc occurs between the electrodes. At this time the steam bubble begins to form and a high current begins to flow through the electrodes. In accordance with embodiments of the invention, responsive to the current through the electrodes, the application of the high voltage is terminated. This conserves energy applied to the electrodes, causing the electrodes to remain useful for a greater number of pulses than otherwise would be the case if the high voltage were applied longer or sustained throughout the bubble existence. The advantages of controlling the applied energy in this manner are obtained without adversely affecting the intensity of the leading edge shock waves produced. -
FIG. 6 is a schematic diagram of apower source 80 for use in an electrical arc shock wave angioplasty catheter according to an embodiment of the invention. Thepower source 80 has anoutput terminal 82 that may be coupled toelectrode 22 ofFIG. 1 and an output terminal 84 that may be coupled toelectrode 24 ofFIG. 1 . Aswitch circuit 86 selectively applies a high voltage online 88 across the electrodes. Amicroprocessor 90, or other similar control circuitry, such as a gate array, controls the overall operation of thesource 80. A Field Programmable Gate Array (FPGA) may also be substituted for the microprocessor in a manner know in the art. Themicroprocessor 90 is coupled to theswitch 86 by anoptical driver 92. The switch includes acurrent sensor 94 that includes a current sensing resistor 96 that generates a signal that is applied to anoptical isolator 98 when the current flowing through the electrodes reaches a predetermined limit, such as, for example, fifty (50) amperes. - In operation, the
microprocessor 90 through theoptical driver 92, causes theswitch 86 to apply the high voltage to theelectrodes microprocessor 90 through theoptical isolator 98. When the current flowing through the electrodes reaches a predetermined limit, as for example 50 amperes, themicroprocessor 90 causes the application of the high voltage to be terminated. The forgoing occurs for each high voltage pulse applied to theelectrodes -
FIG. 7 is a side view of a dilating catheter with an electrical arc producing electrode structure and a temperature probe therein according to aspects of the invention. Thecatheter 20 ofFIG. 7 may be the same catheter as shown inFIG. 1 . Here however, thecatheter 20 further includes a temperature probe orsensor 100. The temperature sensor may be employed for sensing the temperature of the fluid within the balloon. Preferably, the temperature of the fluid within theballoon 26 should not be permitted to rise more than two degrees Celsius above the ambient body temperature. If this were to occur, soft tissue damage may result. -
FIG. 8 is a schematic diagram of anangioplasty catheter system 110 according to further embodiments of the invention which includes thecatheter 20 andtemperature probe 100. Here the system also includes themicroprocessor 90, theswitch 86,optical driver 92 andoptical isolator 98. All of these elements may function as previously described. In addition, thetemperature sensor 100 conveys a temperature signal through anotheroptical isolator 120 indicative of the temperature of the fluid within theballoon 26. If the temperature within theballoon 26 rises to more than a certain temperature, for example to more than two degrees Celsius above ambient body temperature, the energy applied to the electrodes is decreased. This will decrease the size and duration of the steam bubbles produced by the electrodes to maintain the temperature of the fluid within the balloon to within safe limits. Themicroprocessor 90 may cause theswitch 86 to decrease the pulse amplitude of the applied high voltage pulses or the pulse rate of the applied high voltage pulse. It could alternatively temporarily terminate the application of the pulses. -
FIG. 9 is a simplified side view, partly in section, of a further embodiment wherein a balloon is not required. In this embodiment, asystem 134, according to further aspects of the invention, is shown treating an obstruction, more particularly, akidney stone 131. The system includes acatheter 133 that terminates at its distal end with anelectrode pair 132 similar toelectrode pair 25 ofFIGS. 1 and 2 . The system further includes apower source 140. The power source has apositive output terminal 142 and a negative output terminal 144. The center electrode of theelectrode pair 132 may be coupled to thepositive terminal 142 ofsource 140 and the ring electrode of theelectrode pair 132 may be coupled to the negative terminal 144 of thesource 140. The electrodes of theelectrode pair 132 may be formed of metal, such as stainless steel, and are maintained a controlled distance apart to allow a reproducible arc to form for a given applied voltage and current. - The
catheter 133 ofsystem 134 is shown in aureter 130. The ureter has akidney stone 131 requiring treatment. According to this embodiment, voltage pulses are applied to theelectrode pair 132 to produce leading edge shock waves as previously described. The shock waves propagate through the fluid within the ureter and impinge directly on thekidney stone 131. In a manner as previously described, the power source may be operated to maintain the energy applied to the electrode pair within limits to assure that the steam bubbles produced by the generated arcs do not harm the ureter. To that end, the amplitude or pulse rate of the applied voltages may be controlled. Hence, by controlling the energy of the current during the produced arc, such as by controlling the on time of the current, barotrauma to the ureter may be minimized even though a balloon is not employed as in previous embodiments. Of course, the system ofFIG. 9 may be used in other body organs as well, such as the bile duct, for example. -
FIG. 10 is a flow diagram illustrating the process of a further embodiment of the invention. The embodiment ofFIG. 10 takes into account the time it takes for a high voltage switch, such as switch 86 (FIG. 6 ), to turn off (the turn off time) and the rise time of the current flowing through the electrodes once the electrical arc starts. The current through the electrodes can eventually reach one-hundred amperes or more, at which point the maximum intensity shock wave will be formed. In order to permit the maximum current to be reached and to account for the turn off time of theswitch 86, a delay is timed extending from when the current flowing through the electrodes is at a fixed threshold known to be below the maximum current, to the turn off time of the switch before the expected current maximum. For example, the current threshold may be fifty amperes. When the current through the electrodes equals fifty amperes, the delay timing is begun by the starting of a delay timer within themicroprocessor 90. If the current is expected to be at a maximum 200 nanoseconds after the current reaches fifty amperes, and if it takes 100 nanoseconds for the high voltage switch to actually turn off after receiving a turn off signal, a delay of 100 nanoseconds should be timed from the 50 ampere sensing before a turn off signal is applied to the high voltage switch. Hence, a total time of 200 nanoseconds will pass after thecurrent reaches 50 amperes and, as a result, will reach its maximum. As the current reaches its maximum, or shortly thereafter, the voltage applied to the electrodes will be terminated. - Referring now to the flow diagram 200 of
FIG. 10 , and also with reference toFIG. 6 , the process begins withactivity step 202 wherein the high voltage is applied to theoutput terminals 82 and 84 for application to the electrodes, for example,electrodes 22 and 24 (FIG. 1 ). At first, the current initially flowing through the electrodes is relatively low. However, after a dwell time, the applied high voltage causes an electrical arc to begin to form between the electrodes, the current through the electrodes is sensed, and the current rapidly rises. The current through the electrodes is sensed as previously described. Atdecision block 204, themicroprocessor 90 determines if the sensed current has reached fifty amperes. When the current reaches fifty amperes, the process advances to activity block 206 where the timing of the aforementioned delay time (x) is started. Next, indecision block 208, it is determined when the delay time has been timed. In accordance with this embodiment, the delay time (x) may be 100 nanoseconds. When the delay time of 100 nanoseconds is timed, the process advances to activity block 210 wherein the process completes with a turn off signal being applied by themicroprocessor 90 to thehigh voltage switch 86. Theswitch 86 will actually turn of a turn of time after the turn off signal is applied to theswitch 86. Since it takes 100 nanoseconds for the switch to turn off and since 100 nanoseconds are timed before the turn off signal is applied to the switch, 200 nanoseconds form the 50 ampere current sensing will pass before the applied voltage to the electrodes is actually terminated. That provides sufficient time for the current to reach its maximum to generate the maximum intensity shock wave. The voltage application will terminated as the current reaches maximum, or shortly thereafter. - As a result of the foregoing, a maximum intensity shock wave is formed without wasting energy, without unduly eroding the electrodes, and without generating unnecessary heat. As may be appreciated, the delay timing may be employed to advantage in each of the embodiments disclosed herein including the embodiment of
FIG. 9 which does not require a balloon. - The subject method can be used with various electrode designs. For example, the electrodes can be provided with a low profile to improve the ability of the catheter to navigate small vessels. An example of such a low profile electrode design can be found in U.S. Pat. No. 8,747,416. It may also desirable to alternate the polarity of the voltage pulses to even up the wear on the electrodes. An example of an approach for alternating the polarity of the voltage pulses can be found in U.S. Pat. No. 10,226,265.
- While particular embodiments of the present invention have been shown and described, modifications may be made. It is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention as defined by those claims.
Claims (20)
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11801066B2 (en) | 2021-08-05 | 2023-10-31 | Nextern Innovation, Llc | Systems, devices and methods for selection of arc location within a lithoplasty balloon spark gap |
US11877761B2 (en) | 2021-08-05 | 2024-01-23 | Nextern Innovation, Llc | Systems, devices and methods for monitoring voltage and current and controlling voltage of voltage pulse generators |
US11896248B2 (en) | 2021-08-05 | 2024-02-13 | Nextern Innovation, Llc | Systems, devices and methods for generating subsonic pressure waves in intravascular lithotripsy |
US11957369B2 (en) | 2021-08-05 | 2024-04-16 | Nextern Innovation, Llc | Intravascular lithotripsy systems and methods |
Families Citing this family (92)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9072534B2 (en) | 2008-06-13 | 2015-07-07 | Shockwave Medical, Inc. | Non-cavitation shockwave balloon catheter system |
US20130030431A1 (en) * | 2008-06-13 | 2013-01-31 | Adams John M | Shock wave balloon catheter system with off center shock wave generator |
US10702293B2 (en) | 2008-06-13 | 2020-07-07 | Shockwave Medical, Inc. | Two-stage method for treating calcified lesions within the wall of a blood vessel |
JP5636363B2 (en) * | 2008-06-13 | 2014-12-03 | ディージェイティー、 エルエルシー | Shock wave balloon catheter device |
US9180280B2 (en) * | 2008-11-04 | 2015-11-10 | Shockwave Medical, Inc. | Drug delivery shockwave balloon catheter system |
US9044618B2 (en) | 2008-11-05 | 2015-06-02 | Shockwave Medical, Inc. | Shockwave valvuloplasty catheter system |
BR112012017977A2 (en) | 2010-01-19 | 2016-05-03 | Univ Texas | apparatus and systems for generating high frequency shock waves, and methods of use. |
AR087170A1 (en) | 2011-07-15 | 2014-02-26 | Univ Texas | APPARATUS FOR GENERATING THERAPEUTIC SHOCK WAVES AND ITS APPLICATIONS |
US11311332B2 (en) | 2011-08-23 | 2022-04-26 | Magneto Thrombectomy Solutions Ltd. | Thrombectomy devices |
US8574247B2 (en) | 2011-11-08 | 2013-11-05 | Shockwave Medical, Inc. | Shock wave valvuloplasty device with moveable shock wave generator |
US9642673B2 (en) | 2012-06-27 | 2017-05-09 | Shockwave Medical, Inc. | Shock wave balloon catheter with multiple shock wave sources |
EP2879597B1 (en) | 2012-08-06 | 2016-09-21 | Shockwave Medical, Inc. | Shockwave catheter |
ES2715678T3 (en) | 2012-08-06 | 2019-06-05 | Shockwave Medical Inc | Low profile electrodes for an angioplasty shock wave catheter |
CA2881211A1 (en) | 2012-08-08 | 2014-02-13 | Shockwave Medical, Inc. | Shockwave valvuloplasty with multiple balloons |
US9138249B2 (en) | 2012-08-17 | 2015-09-22 | Shockwave Medical, Inc. | Shock wave catheter system with arc preconditioning |
US9333000B2 (en) | 2012-09-13 | 2016-05-10 | Shockwave Medical, Inc. | Shockwave catheter system with energy control |
US9522012B2 (en) | 2012-09-13 | 2016-12-20 | Shockwave Medical, Inc. | Shockwave catheter system with energy control |
US10201387B2 (en) | 2013-03-13 | 2019-02-12 | The Spectranetics Corporation | Laser-induced fluid filled balloon catheter |
US10842567B2 (en) | 2013-03-13 | 2020-11-24 | The Spectranetics Corporation | Laser-induced fluid filled balloon catheter |
US9320530B2 (en) | 2013-03-13 | 2016-04-26 | The Spectranetics Corporation | Assisted cutting balloon |
US9730715B2 (en) | 2014-05-08 | 2017-08-15 | Shockwave Medical, Inc. | Shock wave guide wire |
US11246659B2 (en) | 2014-08-25 | 2022-02-15 | The Spectranetics Corporation | Liquid laser-induced pressure wave emitting catheter sheath |
US11058492B2 (en) | 2014-12-30 | 2021-07-13 | The Spectranetics Corporation | Laser-induced pressure wave emitting catheter sheath |
EP3240603B1 (en) | 2014-12-30 | 2019-05-01 | The Spectranetics Corporation | Laser-induced fluid filled balloon catheter |
WO2016109739A1 (en) | 2014-12-30 | 2016-07-07 | The Spectranetics Corporation | Electrically-induced pressure wave emitting catheter sheath |
WO2017087195A1 (en) | 2015-11-18 | 2017-05-26 | Shockwave Medical, Inc. | Shock wave electrodes |
US20170189059A1 (en) * | 2016-01-06 | 2017-07-06 | Boston Scientific Scimed, Inc. | Percutaneous access device |
US10226265B2 (en) | 2016-04-25 | 2019-03-12 | Shockwave Medical, Inc. | Shock wave device with polarity switching |
TWI838078B (en) | 2016-07-21 | 2024-04-01 | 美商席利通公司 | Capacitor-array apparatus for use in generating therapeutic shock waves and apparatus for generating therapeutic shock waves |
AU2017339980B2 (en) | 2016-10-06 | 2022-08-18 | Shockwave Medical, Inc. | Aortic leaflet repair using shock wave applicators |
US10357264B2 (en) | 2016-12-06 | 2019-07-23 | Shockwave Medical, Inc. | Shock wave balloon catheter with insertable electrodes |
WO2018128787A1 (en) * | 2017-01-06 | 2018-07-12 | Translational Technologies, LLC | Extracorporeal shockwave lithotripsy (eswl) system and method using in-situ sensing of system and device data and therapeutic/system/device level control |
KR20230138057A (en) * | 2017-01-17 | 2023-10-05 | 솔리톤, 인코포레이티드 | Rapid pulse electrohydraulic (eh) shockwave generator apparatus with improved acoustic wavefronts |
CN118285905A (en) | 2017-02-19 | 2024-07-05 | 索里顿有限责任公司 | Selective laser-induced optical breakdown in biological media |
US12029475B2 (en) * | 2017-03-22 | 2024-07-09 | Magneto Thrombectomy Solutions Ltd. | Thrombectomy using both electrostatic and suction forces |
US10441300B2 (en) | 2017-04-19 | 2019-10-15 | Shockwave Medical, Inc. | Drug delivery shock wave balloon catheter system |
EP3612110A1 (en) | 2017-04-21 | 2020-02-26 | Boston Scientific Scimed Inc. | Lithotripsy angioplasty devices and methods |
WO2018194980A1 (en) | 2017-04-21 | 2018-10-25 | Boston Scientific Scimed, Inc. | Lithotripsy angioplasty devices and methods |
US11020135B1 (en) | 2017-04-25 | 2021-06-01 | Shockwave Medical, Inc. | Shock wave device for treating vascular plaques |
US10966737B2 (en) | 2017-06-19 | 2021-04-06 | Shockwave Medical, Inc. | Device and method for generating forward directed shock waves |
NL2019807B1 (en) | 2017-10-26 | 2019-05-06 | Boston Scient Scimed Inc | Shockwave generating device |
US11071557B2 (en) | 2017-10-19 | 2021-07-27 | Medtronic Vascular, Inc. | Catheter for creating pulse wave within vasculature |
GB201717634D0 (en) | 2017-10-26 | 2017-12-13 | Statoil Petroleum As | Wellhead assembly installation |
US10709462B2 (en) | 2017-11-17 | 2020-07-14 | Shockwave Medical, Inc. | Low profile electrodes for a shock wave catheter |
WO2019102307A1 (en) | 2017-11-23 | 2019-05-31 | Magneto Thrombectomy Solutions Ltd. | Tubular thrombectomy devices |
US11103262B2 (en) | 2018-03-14 | 2021-08-31 | Boston Scientific Scimed, Inc. | Balloon-based intravascular ultrasound system for treatment of vascular lesions |
WO2019200201A1 (en) | 2018-04-12 | 2019-10-17 | The Regents Of The University Of Michigan | System for effecting and controlling oscillatory pressure within balloon catheters for fatigue fracture of calculi |
EP3809988B1 (en) | 2018-06-21 | 2023-06-07 | Shockwave Medical, Inc. | System for treating occlusions in body lumens |
US20200060704A1 (en) * | 2018-08-21 | 2020-02-27 | Moshe Ein-Gal | Direct contact shockwave transducer |
CN109223100A (en) * | 2018-09-03 | 2019-01-18 | 沛嘉医疗科技(苏州)有限公司 | It is a kind of for treating the device and its application method of heart valve and angiosteosis |
US11419628B2 (en) * | 2018-09-10 | 2022-08-23 | Medtronic Vascular, Inc. | Tissue-removing catheter with guidewire detection sensor |
WO2020086361A1 (en) | 2018-10-24 | 2020-04-30 | Boston Scientific Scimed, Inc. | Photoacoustic pressure wave generation for intravascular calcification disruption |
US11266817B2 (en) | 2018-10-25 | 2022-03-08 | Medtronic Vascular, Inc. | Cavitation catheter |
US11357958B2 (en) | 2018-10-25 | 2022-06-14 | Medtronic Vascular, Inc. | Devices and techniques for cardiovascular intervention |
FR3091409B1 (en) * | 2018-12-31 | 2020-12-25 | Adm28 S Ar L | Pulse electric discharge device |
US11717139B2 (en) | 2019-06-19 | 2023-08-08 | Bolt Medical, Inc. | Plasma creation via nonaqueous optical breakdown of laser pulse energy for breakup of vascular calcium |
WO2020256898A1 (en) | 2019-06-19 | 2020-12-24 | Boston Scientific Scimed, Inc. | Balloon surface photoacoustic pressure wave generation to disrupt vascular lesions |
US11660427B2 (en) | 2019-06-24 | 2023-05-30 | Boston Scientific Scimed, Inc. | Superheating system for inertial impulse generation to disrupt vascular lesions |
US11399862B2 (en) | 2019-06-24 | 2022-08-02 | Boston Scientific Scimed, Inc. | Propulsion system for inertial energy transfer to disrupt vascular lesions |
US11517713B2 (en) | 2019-06-26 | 2022-12-06 | Boston Scientific Scimed, Inc. | Light guide protection structures for plasma system to disrupt vascular lesions |
CN110811762A (en) * | 2019-08-08 | 2020-02-21 | 谱创医疗科技(上海)有限公司 | Shock wave enhanced drug delivery catheter |
CN114760940A (en) | 2019-09-24 | 2022-07-15 | 冲击波医疗公司 | Focus-through shock wave guide |
AU2020354380A1 (en) * | 2019-09-24 | 2022-04-07 | Shockwave Medical, Inc. | System for treating thrombus in body lumens |
CN110575224A (en) * | 2019-09-30 | 2019-12-17 | 玉龙纳西族自治县人民医院 | Therapeutic ERCP common bile duct calculus expanding and fetching device |
US11583339B2 (en) | 2019-10-31 | 2023-02-21 | Bolt Medical, Inc. | Asymmetrical balloon for intravascular lithotripsy device and method |
CN111157862A (en) * | 2020-01-20 | 2020-05-15 | 南方电网科学研究院有限责任公司 | Large-current impact discharge arc detection system |
CN111157861A (en) * | 2020-01-20 | 2020-05-15 | 南方电网科学研究院有限责任公司 | Heavy current electric arc shock wave detection system |
US11672599B2 (en) | 2020-03-09 | 2023-06-13 | Bolt Medical, Inc. | Acoustic performance monitoring system and method within intravascular lithotripsy device |
US20210290286A1 (en) | 2020-03-18 | 2021-09-23 | Bolt Medical, Inc. | Optical analyzer assembly and method for intravascular lithotripsy device |
US11707323B2 (en) | 2020-04-03 | 2023-07-25 | Bolt Medical, Inc. | Electrical analyzer assembly for intravascular lithotripsy device |
US11992232B2 (en) | 2020-10-27 | 2024-05-28 | Shockwave Medical, Inc. | System for treating thrombus in body lumens |
CR20230304A (en) | 2020-12-11 | 2023-10-16 | Shockwave Medical Inc | Lesion crossing shock wave catheter |
JP2024500359A (en) | 2020-12-11 | 2024-01-09 | リサーチ ディベロップメント ファウンデーション | Systems and methods for laser-induced calcium fragmentation |
US12016610B2 (en) | 2020-12-11 | 2024-06-25 | Bolt Medical, Inc. | Catheter system for valvuloplasty procedure |
WO2022127507A1 (en) * | 2020-12-16 | 2022-06-23 | 深圳市赛禾医疗技术有限公司 | Pressure wave balloon catheter and medical device |
CN112932609A (en) * | 2021-01-06 | 2021-06-11 | 苏州中荟医疗科技有限公司 | Shock wave generation system for cardiovascular stenosis |
US11672585B2 (en) | 2021-01-12 | 2023-06-13 | Bolt Medical, Inc. | Balloon assembly for valvuloplasty catheter system |
US11484327B2 (en) | 2021-02-26 | 2022-11-01 | Fastwave Medical Inc. | Intravascular lithotripsy |
US11944331B2 (en) | 2021-02-26 | 2024-04-02 | Fastwave Medical Inc. | Intravascular lithotripsy |
US11911056B2 (en) | 2021-02-26 | 2024-02-27 | Fastwave Medical Inc. | Intravascular lithotripsy |
CN112914719A (en) * | 2021-03-24 | 2021-06-08 | 上海微创旋律医疗科技有限公司 | Electrode balloon catheter and high-voltage generation treatment device |
US11648057B2 (en) | 2021-05-10 | 2023-05-16 | Bolt Medical, Inc. | Optical analyzer assembly with safety shutdown system for intravascular lithotripsy device |
US11806075B2 (en) | 2021-06-07 | 2023-11-07 | Bolt Medical, Inc. | Active alignment system and method for laser optical coupling |
US12023098B2 (en) | 2021-10-05 | 2024-07-02 | Shockwave Medical, Inc. | Lesion crossing shock wave catheter |
EP4419023A1 (en) | 2021-10-19 | 2024-08-28 | Shockwave Medical, Inc. | Intravascular lithotripsy catheter with interfering shock waves |
CN113855163B (en) * | 2021-11-09 | 2024-03-22 | 上海蓝帆博元医疗科技有限公司 | Shock wave electrode assembly, balloon catheter device and medical equipment |
US11839391B2 (en) | 2021-12-14 | 2023-12-12 | Bolt Medical, Inc. | Optical emitter housing assembly for intravascular lithotripsy device |
WO2023235665A1 (en) | 2022-06-01 | 2023-12-07 | Fastwave Medical Inc. | Intravascular lithotripsy |
CN115804628B (en) * | 2022-07-26 | 2024-02-13 | 鑫易舟(上海)医疗器械有限公司 | Medical device, control method thereof, IVL system and energy adjustment system |
WO2024102896A2 (en) * | 2022-11-11 | 2024-05-16 | Nextern Innovation, Llc | Control of ivl systems, devices and methods thereof |
US20240206896A1 (en) * | 2022-12-22 | 2024-06-27 | Cardiovascular Systems, Inc. | Intravascular lithotripsy devices and systems having spark monitoring feedback |
US12035932B1 (en) | 2023-04-21 | 2024-07-16 | Shockwave Medical, Inc. | Intravascular lithotripsy catheter with slotted emitter bands |
Family Cites Families (139)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3413976A (en) | 1963-07-29 | 1968-12-03 | G Elektrotekhnichesky Zd Vef | Arrangement for removal of concretions from urinary tract |
US3412288A (en) | 1965-01-25 | 1968-11-19 | Gen Motors Corp | Arc suppression circuit for inductive loads |
AT309663B (en) | 1971-05-14 | 1973-08-27 | Phil Heinz Schmidt Kloiber Dr | Device for destroying stones in the bladder, ureter, kidney and the like. like |
US3902499A (en) | 1974-01-02 | 1975-09-02 | Hoffman Saul | Stone disintegrator |
US4027674A (en) | 1975-06-06 | 1977-06-07 | Tessler Arthur N | Method and device for removing concretions within human ducts |
US4900303A (en) | 1978-03-10 | 1990-02-13 | Lemelson Jerome H | Dispensing catheter and method |
DE3038445A1 (en) | 1980-10-11 | 1982-05-27 | Dornier Gmbh, 7990 Friedrichshafen | Pressure wave generator for diagnosis and therapy - has spark gap in inflatable balloon at end of catheter |
US4685458A (en) | 1984-03-01 | 1987-08-11 | Vaser, Inc. | Angioplasty catheter and method for use thereof |
JPS6125915A (en) | 1984-07-14 | 1986-02-05 | Fuji Heavy Ind Ltd | Intake-air device in internal-combustion engine |
US4671254A (en) | 1985-03-01 | 1987-06-09 | Memorial Hospital For Cancer And Allied Diseases | Non-surgical method for suppression of tumor growth |
US5176675A (en) | 1985-04-24 | 1993-01-05 | The General Hospital Corporation | Use of lasers to break down objects for removal from within the body |
DE3543881C1 (en) | 1985-12-12 | 1987-03-26 | Dornier Medizintechnik | Underwater electrode for non-contact lithotripsy |
JPS62275446A (en) | 1986-05-21 | 1987-11-30 | オリンパス光学工業株式会社 | Discharge stone crushing apparatus |
US4662126A (en) | 1986-05-23 | 1987-05-05 | Fike Corporation | Vibration resistant explosion control vent |
US4890603A (en) | 1987-11-09 | 1990-01-02 | Filler William S | Extracorporeal shock wave lithotripsy employing non-focused, spherical-sector shock waves |
WO1989011311A1 (en) | 1988-05-18 | 1989-11-30 | Kasevich Associates, Inc. | Microwave balloon angioplasty |
EP0355177A1 (en) | 1988-08-17 | 1990-02-28 | Siemens Aktiengesellschaft | Apparatus for the contactless desintegration of concrements in a living thing body |
US4955377A (en) | 1988-10-28 | 1990-09-11 | Lennox Charles D | Device and method for heating tissue in a patient's body |
US5425735A (en) | 1989-02-22 | 1995-06-20 | Psi Medical Products, Inc. | Shielded tip catheter for lithotripsy |
US5281231A (en) | 1989-02-22 | 1994-01-25 | Physical Sciences, Inc. | Impact lithotrypsy |
US5246447A (en) | 1989-02-22 | 1993-09-21 | Physical Sciences, Inc. | Impact lithotripsy |
US6146358A (en) | 1989-03-14 | 2000-11-14 | Cordis Corporation | Method and apparatus for delivery of therapeutic agent |
US5078717A (en) | 1989-04-13 | 1992-01-07 | Everest Medical Corporation | Ablation catheter with selectively deployable electrodes |
DE3937904C2 (en) | 1989-11-15 | 1994-05-11 | Dornier Medizintechnik | Improvement of the ignition behavior on an underwater spark gap |
US5002085A (en) | 1990-02-12 | 1991-03-26 | Bs&B Safety Systems, Inc. | Low pressure non-fragmenting rupture disks |
US5057103A (en) | 1990-05-01 | 1991-10-15 | Davis Emsley A | Compressive intramedullary nail |
US5103804A (en) | 1990-07-03 | 1992-04-14 | Boston Scientific Corporation | Expandable tip hemostatic probes and the like |
US5152767A (en) | 1990-11-23 | 1992-10-06 | Northgate Technologies, Inc. | Invasive lithotripter with focused shockwave |
US6524274B1 (en) | 1990-12-28 | 2003-02-25 | Scimed Life Systems, Inc. | Triggered release hydrogel drug delivery system |
US5893840A (en) | 1991-01-04 | 1999-04-13 | Medtronic, Inc. | Releasable microcapsules on balloon catheters |
US5102402A (en) | 1991-01-04 | 1992-04-07 | Medtronic, Inc. | Releasable coatings on balloon catheters |
US5324255A (en) | 1991-01-11 | 1994-06-28 | Baxter International Inc. | Angioplasty and ablative devices having onboard ultrasound components and devices and methods for utilizing ultrasound to treat or prevent vasopasm |
US5152768A (en) | 1991-02-26 | 1992-10-06 | Bhatta Krishna M | Electrohydraulic lithotripsy |
US5116227A (en) | 1991-03-01 | 1992-05-26 | Endo Technic Corporation | Process for cleaning and enlarging passages |
US5395335A (en) | 1991-05-24 | 1995-03-07 | Jang; G. David | Universal mode vascular catheter system |
EP0606390A4 (en) | 1991-10-03 | 1994-12-07 | Gen Hospital Corp | Apparatus and method for vasodilation. |
US6406486B1 (en) | 1991-10-03 | 2002-06-18 | The General Hospital Corporation | Apparatus and method for vasodilation |
US6179824B1 (en) | 1993-05-10 | 2001-01-30 | Arthrocare Corporation | System and methods for electrosurgical restenosis of body lumens |
EP0571306A1 (en) | 1992-05-22 | 1993-11-24 | LASER MEDICAL TECHNOLOGY, Inc. | Apparatus and method for removal of deposits from the walls of body passages |
US5362309A (en) | 1992-09-14 | 1994-11-08 | Coraje, Inc. | Apparatus and method for enhanced intravascular phonophoresis including dissolution of intravascular blockage and concomitant inhibition of restenosis |
JPH06125915A (en) | 1992-10-21 | 1994-05-10 | Inter Noba Kk | Catheter type medical instrument |
CA2114988A1 (en) | 1993-02-05 | 1994-08-06 | Matthew O'boyle | Ultrasonic angioplasty balloon catheter |
US5321715A (en) | 1993-05-04 | 1994-06-14 | Coherent, Inc. | Laser pulse format for penetrating an absorbing fluid |
CA2118886C (en) | 1993-05-07 | 1998-12-08 | Dennis Vigil | Method and apparatus for dilatation of a stenotic vessel |
US5417208A (en) | 1993-10-12 | 1995-05-23 | Arrow International Investment Corp. | Electrode-carrying catheter and method of making same |
US8025661B2 (en) | 1994-09-09 | 2011-09-27 | Cardiofocus, Inc. | Coaxial catheter instruments for ablation with radiant energy |
US5603731A (en) | 1994-11-21 | 1997-02-18 | Whitney; Douglass G. | Method and apparatus for thwarting thrombosis |
DE19504261A1 (en) | 1995-02-09 | 1996-09-12 | Krieg Gunther | Angioplasty catheter for dilating and / or opening blood vessels |
US5582578A (en) | 1995-08-01 | 1996-12-10 | Duke University | Method for the comminution of concretions |
CN1204242A (en) * | 1995-10-13 | 1999-01-06 | 血管转换公司 | Method and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures |
US20020045890A1 (en) | 1996-04-24 | 2002-04-18 | The Regents Of The University O F California | Opto-acoustic thrombolysis |
US5846218A (en) | 1996-09-05 | 1998-12-08 | Pharmasonics, Inc. | Balloon catheters having ultrasonically driven interface surfaces and methods for their use |
US6352535B1 (en) | 1997-09-25 | 2002-03-05 | Nanoptics, Inc. | Method and a device for electro microsurgery in a physiological liquid environment |
US6083232A (en) | 1996-09-27 | 2000-07-04 | Advanced Cardivascular Systems, Inc. | Vibrating stent for opening calcified lesions |
DE19718513C5 (en) | 1997-05-02 | 2010-06-02 | Sanuwave, Inc., | Device for generating acoustic shock waves, in particular for medical use |
US6024740A (en) | 1997-07-08 | 2000-02-15 | The Regents Of The University Of California | Circumferential ablation device assembly |
US5931805A (en) | 1997-06-02 | 1999-08-03 | Pharmasonics, Inc. | Catheters comprising bending transducers and methods for their use |
AU741167B2 (en) | 1997-07-08 | 2001-11-22 | Atrionix, Inc. | Circumferential ablation device assembly and method |
US6500174B1 (en) | 1997-07-08 | 2002-12-31 | Atrionix, Inc. | Circumferential ablation device assembly and methods of use and manufacture providing an ablative circumferential band along an expandable member |
AU1185699A (en) | 1997-10-21 | 1999-05-10 | Endovasix, Inc. | Photoacoustic removal of occlusions from blood vessels |
DE59814001D1 (en) | 1997-10-24 | 2007-06-21 | Mts Europ Gmbh | Method for the automatic adjustment of the electrode gap of a spark gap in electro-hydraulic shock wave systems |
US6206283B1 (en) | 1998-12-23 | 2001-03-27 | At&T Corp. | Method and apparatus for transferring money via a telephone call |
US6755821B1 (en) | 1998-12-08 | 2004-06-29 | Cardiocavitational Systems, Inc. | System and method for stimulation and/or enhancement of myocardial angiogenesis |
US6210408B1 (en) | 1999-02-24 | 2001-04-03 | Scimed Life Systems, Inc. | Guide wire system for RF recanalization of vascular blockages |
US6277138B1 (en) | 1999-08-17 | 2001-08-21 | Scion Cardio-Vascular, Inc. | Filter for embolic material mounted on expandable frame |
US6398792B1 (en) | 1999-06-21 | 2002-06-04 | O'connor Lawrence | Angioplasty catheter with transducer using balloon for focusing of ultrasonic energy and method for use |
DE19929112A1 (en) | 1999-06-24 | 2001-01-11 | Ferton Holding Sa | Medical instrument for the treatment of biological tissue and method for transmitting pressure waves |
US20040097996A1 (en) | 1999-10-05 | 2004-05-20 | Omnisonics Medical Technologies, Inc. | Apparatus and method of removing occlusions using an ultrasonic medical device operating in a transverse mode |
US6652547B2 (en) | 1999-10-05 | 2003-11-25 | Omnisonics Medical Technologies, Inc. | Apparatus and method of removing occlusions using ultrasonic medical device operating in a transverse mode |
US20040249401A1 (en) | 1999-10-05 | 2004-12-09 | Omnisonics Medical Technologies, Inc. | Apparatus and method for an ultrasonic medical device with a non-compliant balloon |
US6524251B2 (en) | 1999-10-05 | 2003-02-25 | Omnisonics Medical Technologies, Inc. | Ultrasonic device for tissue ablation and sheath for use therewith |
US6371971B1 (en) | 1999-11-15 | 2002-04-16 | Scimed Life Systems, Inc. | Guidewire filter and methods of use |
US6589253B1 (en) | 1999-12-30 | 2003-07-08 | Advanced Cardiovascular Systems, Inc. | Ultrasonic angioplasty transmission wire |
US20010044596A1 (en) | 2000-05-10 | 2001-11-22 | Ali Jaafar | Apparatus and method for treatment of vascular restenosis by electroporation |
US7744595B2 (en) | 2000-08-01 | 2010-06-29 | Arqos Surgical, Inc. | Voltage threshold ablation apparatus |
US6367203B1 (en) | 2000-09-11 | 2002-04-09 | Oklahoma Safety Equipment Co., Inc. | Rupture panel |
US6638246B1 (en) | 2000-11-28 | 2003-10-28 | Scimed Life Systems, Inc. | Medical device for delivery of a biologically active material to a lumen |
US6514203B2 (en) | 2001-02-12 | 2003-02-04 | Sonata Technologies Ltd. | Method for ultrasonic coronary thrombolysis |
US6607003B1 (en) | 2001-04-23 | 2003-08-19 | Oklahoma Safety Equipment Co, | Gasket-lined rupture panel |
US6666828B2 (en) | 2001-06-29 | 2003-12-23 | Medtronic, Inc. | Catheter system having disposable balloon |
US7674258B2 (en) | 2002-09-24 | 2010-03-09 | Endoscopic Technologies, Inc. (ESTECH, Inc.) | Electrophysiology electrode having multiple power connections and electrophysiology devices including the same |
US6740081B2 (en) | 2002-01-25 | 2004-05-25 | Applied Medical Resources Corporation | Electrosurgery with improved control apparatus and method |
US7087061B2 (en) | 2002-03-12 | 2006-08-08 | Lithotech Medical Ltd | Method for intracorporeal lithotripsy fragmentation and apparatus for its implementation |
US6989009B2 (en) | 2002-04-19 | 2006-01-24 | Scimed Life Systems, Inc. | Cryo balloon |
US7829029B2 (en) | 2002-05-29 | 2010-11-09 | NanoVibronix, Inv. | Acoustic add-on device for biofilm prevention in urinary catheter |
US7153315B2 (en) | 2002-06-11 | 2006-12-26 | Boston Scientific Scimed, Inc. | Catheter balloon with ultrasonic microscalpel blades |
US6866662B2 (en) | 2002-07-23 | 2005-03-15 | Biosense Webster, Inc. | Ablation catheter having stabilizing array |
JP2004081374A (en) | 2002-08-26 | 2004-03-18 | Dairin Kk | Instrument for removing sediment in tubular organ |
US20040097963A1 (en) | 2002-11-19 | 2004-05-20 | Seddon J. Michael | Method and apparatus for disintegrating urinary tract stones |
US20040162508A1 (en) | 2003-02-19 | 2004-08-19 | Walter Uebelacker | Shock wave therapy method and device |
DE10311659B4 (en) * | 2003-03-14 | 2006-12-21 | Sws Shock Wave Systems Ag | Apparatus and method for optimized electrohydraulic pressure pulse generation |
US7628785B2 (en) | 2003-06-13 | 2009-12-08 | Piezo Technologies | Endoscopic medical treatment involving acoustic ablation |
US7247269B2 (en) | 2003-07-21 | 2007-07-24 | Biosense Webster, Inc. | Method for making a spiral array ultrasound transducer |
JP4072580B2 (en) | 2003-09-25 | 2008-04-09 | ケイセイ医科工業株式会社 | Thrombectomy catheter |
US20070282301A1 (en) | 2004-02-26 | 2007-12-06 | Segalescu Victor A | Dilatation Balloon Catheter Including External Means For Endoluminal Therapy And For Drug Activation |
US7754047B2 (en) | 2004-04-08 | 2010-07-13 | Boston Scientific Scimed, Inc. | Cutting balloon catheter and method for blade mounting |
CN1942145A (en) * | 2004-04-19 | 2007-04-04 | 普罗里森姆股份有限公司 | Ablation devices with sensor structures |
US7720521B2 (en) | 2004-04-21 | 2010-05-18 | Acclarent, Inc. | Methods and devices for performing procedures within the ear, nose, throat and paranasal sinuses |
WO2006006169A2 (en) | 2004-07-14 | 2006-01-19 | By-Pass, Inc. | Material delivery system |
WO2006060492A2 (en) | 2004-12-01 | 2006-06-08 | Ethicon Endo-Surgery, Inc. | Ultrasonic device and method for treating stones within the body |
US20060241524A1 (en) | 2005-03-11 | 2006-10-26 | Qi Yu | Intravascular ultrasound catheter device and method for ablating atheroma |
US7595615B2 (en) | 2005-04-05 | 2009-09-29 | Texas Instruments Incorporated | Systems and methods for providing over-current protection in a switching power supply |
EP1714642A1 (en) | 2005-04-18 | 2006-10-25 | Bracco Research S.A. | Pharmaceutical composition comprising gas-filled microcapsules for ultrasound mediated delivery |
US8162859B2 (en) | 2005-06-09 | 2012-04-24 | General Patent , LLC | Shock wave treatment device and method of use |
US20070088380A1 (en) | 2005-10-14 | 2007-04-19 | Endocross Ltd. | Balloon catheter system for treating vascular occlusions |
DE602006014206D1 (en) | 2006-01-03 | 2010-06-17 | Alcon Inc | SYSTEM FOR CUTTING AND REMOVING PROTEINOUS TISSUE |
US20070239082A1 (en) | 2006-01-27 | 2007-10-11 | General Patent, Llc | Shock Wave Treatment Device |
US20070239253A1 (en) | 2006-04-06 | 2007-10-11 | Jagger Karl A | Oscillation assisted drug elution apparatus and method |
US7651492B2 (en) | 2006-04-24 | 2010-01-26 | Covidien Ag | Arc based adaptive control system for an electrosurgical unit |
US20080097251A1 (en) | 2006-06-15 | 2008-04-24 | Eilaz Babaev | Method and apparatus for treating vascular obstructions |
CN101505668A (en) | 2006-06-20 | 2009-08-12 | 奥尔特克斯公司 | Prosthetic valve implant site preparation techniques |
EP2076198A4 (en) | 2006-10-18 | 2009-12-09 | Minnow Medical Inc | Inducing desirable temperature effects on body tissue |
WO2009053839A2 (en) | 2007-10-22 | 2009-04-30 | Endocross Ltd. | Balloons and balloon catheter systems for treating vascular occlusions |
WO2009121009A2 (en) | 2008-03-27 | 2009-10-01 | The Regents Of The University Of California | Irreversible electroporation device for use in attenuating neointimal |
EP2274741B1 (en) | 2008-04-14 | 2016-08-31 | Avner Spector | Shockwave medical therapy device with automatic adjustable voltage to stabilize pressure and corresponding adjustment method |
US20100036294A1 (en) | 2008-05-07 | 2010-02-11 | Robert Mantell | Radially-Firing Electrohydraulic Lithotripsy Probe |
US20130030431A1 (en) | 2008-06-13 | 2013-01-31 | Adams John M | Shock wave balloon catheter system with off center shock wave generator |
US9072534B2 (en) | 2008-06-13 | 2015-07-07 | Shockwave Medical, Inc. | Non-cavitation shockwave balloon catheter system |
JP5636363B2 (en) | 2008-06-13 | 2014-12-03 | ディージェイティー、 エルエルシー | Shock wave balloon catheter device |
US20100016862A1 (en) | 2008-07-16 | 2010-01-21 | Daniel Hawkins | Method of providing embolic protection and shockwave angioplasty therapy to a vessel |
ES2659322T3 (en) | 2008-07-27 | 2018-03-14 | Pi-R-Squared Ltd. | Calcification fractures in heart valves |
US9180280B2 (en) | 2008-11-04 | 2015-11-10 | Shockwave Medical, Inc. | Drug delivery shockwave balloon catheter system |
US9044618B2 (en) | 2008-11-05 | 2015-06-02 | Shockwave Medical, Inc. | Shockwave valvuloplasty catheter system |
ES2610134T3 (en) | 2009-07-08 | 2017-04-26 | Sanuwave, Inc. | Use of extracorporeal and intracorporeal pressure shock waves in medicine |
AU2011238925B2 (en) | 2010-04-09 | 2016-06-16 | Vessix Vascular, Inc. | Power generating and control apparatus for the treatment of tissue |
US9192790B2 (en) | 2010-04-14 | 2015-11-24 | Boston Scientific Scimed, Inc. | Focused ultrasonic renal denervation |
AU2011252976A1 (en) | 2010-05-12 | 2012-11-08 | Shifamed Holdings, Llc | Low profile electrode assembly |
US20120203255A1 (en) | 2011-02-04 | 2012-08-09 | Daniel Hawkins | High pressure balloon shockwave catheter and method |
US20130041355A1 (en) | 2011-08-11 | 2013-02-14 | Tammo Heeren | Reducing Damage From A Dielectric Breakdown in Surgical Applications |
CN110200963A (en) | 2011-10-19 | 2019-09-06 | 墨卡托医疗系统公司 | Local modulation tissue and cell include kidney denervation to improve curative effect |
US8574248B2 (en) | 2011-12-12 | 2013-11-05 | Kassab Kughn Endovascular Devices | Catheter system with balloon-mounted plaque-modifying elements |
US9642673B2 (en) | 2012-06-27 | 2017-05-09 | Shockwave Medical, Inc. | Shock wave balloon catheter with multiple shock wave sources |
CN102765785A (en) | 2012-07-16 | 2012-11-07 | 广州埔玛电气有限公司 | Device and method for sterilizing and disinfecting wastewater by pulsed liquid-phase discharge plasma |
ES2715678T3 (en) | 2012-08-06 | 2019-06-05 | Shockwave Medical Inc | Low profile electrodes for an angioplasty shock wave catheter |
US9237984B2 (en) | 2012-08-10 | 2016-01-19 | Shockwave Medical, Inc. | Shockwave nerve therapy system and method |
US9138249B2 (en) | 2012-08-17 | 2015-09-22 | Shockwave Medical, Inc. | Shock wave catheter system with arc preconditioning |
US9522012B2 (en) | 2012-09-13 | 2016-12-20 | Shockwave Medical, Inc. | Shockwave catheter system with energy control |
US9333000B2 (en) | 2012-09-13 | 2016-05-10 | Shockwave Medical, Inc. | Shockwave catheter system with energy control |
JP7067801B2 (en) | 2016-08-12 | 2022-05-16 | エルセント メディカル,インコーポレイテッド | Equipment, systems, and methods for guiding and monitoring surgical equipment |
-
2012
- 2012-09-13 US US13/615,107 patent/US9333000B2/en active Active
-
2013
- 2013-09-12 WO PCT/US2013/059533 patent/WO2014043400A1/en unknown
- 2013-09-12 JP JP2015532052A patent/JP6364011B2/en active Active
- 2013-09-12 AU AU2013315444A patent/AU2013315444B2/en active Active
- 2013-09-12 EP EP21165848.9A patent/EP3861942B1/en active Active
- 2013-09-12 ES ES13767193T patent/ES2869228T3/en active Active
- 2013-09-12 CN CN201380047277.3A patent/CN104619272B9/en active Active
- 2013-09-12 CA CA2881199A patent/CA2881199C/en active Active
- 2013-09-12 ES ES21165848T patent/ES2960778T3/en active Active
- 2013-09-12 EP EP13767193.9A patent/EP2895086B1/en active Active
- 2013-11-13 US US14/079,463 patent/US8728091B2/en active Active
-
2014
- 2014-05-06 US US14/271,276 patent/US9005216B2/en active Active
-
2016
- 2016-03-09 US US15/065,607 patent/US10159505B2/en active Active
-
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- 2018-12-17 US US16/222,679 patent/US10973538B2/en active Active
-
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- 2019-08-28 US US16/554,497 patent/US10517621B1/en active Active
-
2021
- 2021-03-10 US US17/198,001 patent/US11596424B2/en active Active
-
2023
- 2023-02-03 US US18/105,584 patent/US20230329731A1/en active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11801066B2 (en) | 2021-08-05 | 2023-10-31 | Nextern Innovation, Llc | Systems, devices and methods for selection of arc location within a lithoplasty balloon spark gap |
US11877761B2 (en) | 2021-08-05 | 2024-01-23 | Nextern Innovation, Llc | Systems, devices and methods for monitoring voltage and current and controlling voltage of voltage pulse generators |
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US11957369B2 (en) | 2021-08-05 | 2024-04-16 | Nextern Innovation, Llc | Intravascular lithotripsy systems and methods |
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US9005216B2 (en) | 2015-04-14 |
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CN104619272B9 (en) | 2018-03-13 |
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EP2895086B1 (en) | 2021-05-05 |
US8728091B2 (en) | 2014-05-20 |
AU2013315444A1 (en) | 2015-02-12 |
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