Therapeutic pulse generator

Abstract

A therapeutic electrical pulse delivery system may include a power source, a pulse generator, and a controller. The pulse generator may be operatively coupled to the power source. The pulse generator may include one or more capacitors. Each of the one or more capacitors may include a first electrode, a second electrode, and a dielectric disposed between the first electrode and the second electrode. The one or more capacitors may have an energy capacity that is at least 10% greater than a maximum energy of the therapeutic electrical pulse delivered by the therapeutic electrical pulse delivery system. The controller may include one or more processors and may be operatively coupled to the power source or the pulse generator to charge the one or more capacitors and cause the pulse generator to deliver therapeutic electrical pulses using the charged one or more capacitors.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 441,076, filed on January 25, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present disclosure relates, inter alia, to therapeutic electrical pulse delivery systems and devices. Background Art

[0003] Therapeutic electrical pulse delivery systems and devices often use capacitors to store energy and deliver therapeutic pulses or shocks to patients. A capacitor can store energy in an electric field between two electrodes (e.g., a first electrode and a second electrode). A capacitor can release stored energy faster than a battery or other power source. In addition, the energy stored by a capacitor can have a higher voltage than the energy stored and provided by a typical battery or other power source while occupying a smaller volume. Therefore, capacitors can be used to provide high voltage pulses or shocks in therapeutic electrical pulse delivery systems and devices. Summary of the Invention

[0004] As described herein, therapeutic electrical pulse delivery systems and devices with improved deformation factors, charging times, and lifespans can be achieved using pulse generator capacitors having an energy capacity greater than that required for delivering the therapeutic pulses. A pulse generator of a therapeutic electrical pulse delivery system or device may include one or more capacitors for storing and delivering energy. The system or device may be configured to deliver therapeutic electrical pulses using the pulse generator at or below a maximum energy level. One or more capacitors may have an energy capacity at least 10% greater than the maximum energy level. A capacitor or capacitor bank having an energy capacity greater than that required for delivering the therapeutic electrical pulses may have an improved deformation factor, charging time, and lifespan compared to a capacitor or capacitor bank that only meets the energy capacity requirement for delivering the therapeutic electrical pulses. Thus, the therapeutic electrical pulse delivery systems and devices described herein may have an improved deformation factor, reduced charging time, and increased lifespan. Additionally, the therapeutic electrical pulse delivery systems and devices described herein may have increased charging efficiency.

[0005] In one example, aspects of the present disclosure relate to a therapeutic electrical pulse delivery system for delivering therapeutic electrical pulses. The therapeutic electrical pulse delivery system may include a power source, a pulse generator, and a controller. The pulse generator may be operably coupled to the power source and may include one or more capacitors for storing and delivering energy. The one or more capacitors may have an energy capacity that is at least 10% greater than the maximum energy of the therapeutic electrical pulses delivered by the therapeutic electrical pulse delivery system. The controller may include one or more processors and may be operably coupled to the power source or the pulse generator. The controller may be configured to charge the one or more capacitors of the pulse generator using the power source and cause the pulse generator to deliver the therapeutic electrical pulses using the charged one or more capacitors.

[0006] In another example, aspects of the present disclosure relate to a therapeutic pulse generator for delivering therapeutic electrical pulses. The therapeutic pulse generator may include an input operatively coupled to a power source, one or more capacitors for storing and delivering energy, and an output operatively coupled to the one or more capacitors for delivering the therapeutic electrical pulses using the energy stored in the one or more capacitors. The one or more capacitors may have an energy capacity at least 10% greater than the maximum energy of the therapeutic electrical pulses delivered by the therapeutic pulse generator.

[0007] In another example, aspects of the present disclosure relate to an implantable medical device for delivering therapeutic electrical pulses. The implantable medical device may include a housing suitable for implantation in a patient, a power source disposed in the housing, a pulse generator, and a controller. The pulse generator may be operably coupled to the power source and may include one or more capacitors for storing and delivering energy. The one or more capacitors may have an energy capacity that is at least 10% greater than the maximum energy of the therapeutic electrical pulses delivered by the implantable medical device. The controller may include one or more processors and may be operably coupled to the power source or the pulse generator. The controller is configured to charge the one or more capacitors of the pulse generator using the power source and cause the pulse generator to deliver the therapeutic electrical pulses using the charged one or more capacitors.

[0008] Advantages and additional features of the subject matter of the present disclosure are set forth in the detailed description that follows, and in part will become apparent to those skilled in the art from that description or may be learned by practicing the subject matter of the present disclosure as described herein, including the following detailed description, claims, and accompanying drawings.

[0009] It should be understood that both the foregoing general description and the following detailed description set forth embodiments of the subject matter of the present disclosure and are intended to provide an overview or framework for understanding the nature and characteristics of the subject matter of the present disclosure as claimed. The accompanying drawings are included to provide a further understanding of the subject matter of the present disclosure and are incorporated into and constitute a part of this specification. The accompanying drawings illustrate various embodiments of the subject matter of the present disclosure and, together with the description, serve to explain the principles and operation of the subject matter of the present disclosure. In addition, the drawings and description are intended to be illustrative only and are not intended to limit the scope of the claims in any way. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The following detailed description of specific embodiments of the present disclosure is best understood when read in conjunction with the following drawings, in which:

[0011] Figure 1 is a conceptual diagram illustrating one embodiment of a therapeutic electrical pulse delivery system in conjunction with a patient;

[0012] Figure 2 is a conceptual diagram illustrating another embodiment of a therapeutic electrical pulse delivery system in conjunction with a patient;

[0013] Figure 3 yes Figure 1 and Figure 2 A schematic block diagram of the electronic components of the therapeutic electrical pulse delivery system;

[0014] Figure 4 yes Figures 1 to 3 Schematic block diagram of a pulse generator of a therapeutic electrical pulse delivery system.

[0015] The schematic diagrams are not necessarily drawn to scale. DETAILED DESCRIPTION

[0016] Reference will now be made in greater detail to various embodiments of the subject matter of the present disclosure, one or more of which are illustrated in the accompanying drawings. Like numbers used in the drawings refer to like components and steps. However, it should be understood that the use of numbers to refer to components in a given figure is not intended to limit the components labeled with the same numbers in another figure. Additionally, the use of different numbers to refer to components in different figures is not intended to indicate that differently numbered components cannot be the same or similar to components with other numbers.

[0017] Typically, a therapeutic electrical pulse delivery system, such as an implantable cardioverter-defibrillator, requires time to charge one or more capacitors of a pulse generator in preparation for treatment or therapeutic electrical pulse delivery. The charging time may depend on factors such as the efficiency of the capacitor and the deformation efficiency factor. When the capacitor is a new capacitor, the efficiency of the capacitor may be the ratio of the delivered energy to the input energy of the capacitor. The deformation efficiency factor may be the ratio of the input energy of a used capacitor to the input energy of a new capacitor. Generally speaking, as a capacitor is used or otherwise ages, the ratio of the input energy of the used capacitor to the input energy of the capacitor when it was new increases. Therefore, as the capacitor is used or ages, the deformation factor increases. In other words, an older capacitor may require more energy to charge to the same level than a new capacitor.

[0018] Typically, designs for therapeutic electrical pulse delivery systems seek to achieve smaller devices. Generally speaking, smaller capacitors have lower energy capacities than larger capacitors of the same type and design. Therefore, capacitors selected for therapeutic electrical pulse delivery systems and devices can have energy capacities that meet, but do not significantly exceed, operational requirements. For example, capacitors for therapeutic electrical pulse delivery can be selected that have energy capacities large enough to deliver therapeutic electrical pulses at the maximum energy that the device or system is configured to deliver without exceeding the energy requirements. Selection of capacitors that meet operational energy requirements can allow the use of smaller capacitors.

[0019] However, it has been found that using a capacitor with a higher energy capacity for the same application (e.g., the same therapeutic electrical pulse delivery parameters) may result in a lower deformation efficiency factor than a capacitor with a lower energy capacity. Thus, using a capacitor with a higher energy capacity may result in less power required to charge the capacitor for therapeutic electrical pulse delivery over time. In addition, because less power is required, the same power source may be able to charge the capacitor with a higher energy capacity faster over time. Furthermore, because the deformation factor of the capacitor with a higher energy capacity increases at a slower rate, the therapeutic electrical pulse delivery system can last longer. In other words, therapeutic electrical pulse delivery systems and devices that include a pulse generator capacitor with an energy capacity greater than that required for therapeutic pulse delivery as described herein may allow for improved deformation factor, charging time, lifespan, and charging efficiency.

[0020] As used herein, the term "energy capacity" may refer to the nominal maximum energy that a device (e.g., a capacitor) can be charged to or otherwise stored. For example, a 45 joule capacitor may have a nominal maximum energy capacity of 45 joules.

[0021] According to one aspect, a therapeutic electrical pulse delivery system is provided. The therapeutic electrical pulse delivery system may include a power source, a pulse generator, and a controller. The pulse generator may be operably coupled to the power source. The pulse generator may include one or more capacitors. Each of the one or more capacitors may include a first electrode, a second electrode, and a dielectric disposed between the first electrode and the second electrode. The one or more capacitors may have an energy capacity that is at least 10% greater than the maximum energy of the therapeutic electrical pulse delivered by the therapeutic electrical pulse delivery system. The controller may include one or more processors and may be operably coupled to the power source or the pulse generator. The controller may be configured to charge the one or more capacitors of the pulse generator using the power source, and to cause the pulse generator to deliver the therapeutic electrical pulse using the charged one or more capacitors.

[0022] The pulse generator can include any suitable number of capacitors. In one or more embodiments, the one or more capacitors are comprised of a single capacitor. The use of capacitors with higher energy capacity can allow a single capacitor to have the maximum voltage and capacitance to deliver the therapeutic electrical pulses at the desired voltage. The use of a single capacitor can allow for a reduction in the size and cost of the pulse generator and therapeutic electrical pulse delivery system compared to devices and systems using multiple electrolytic capacitors.

[0023] While the pulse generator may be comprised of a single capacitor, an arrangement including multiple capacitors may allow for a variety of pulse generator arrangements and / or dynamic therapeutic electrical pulse delivery. The one or more capacitors may be arranged to be charged in parallel and to deliver therapeutic electrical pulses in parallel. In other words, each of the one or more capacitors may be arranged such that a terminal of each capacitor is coupled to a first voltage node and another terminal of each capacitor is coupled to a second voltage node. The capacitors arranged to deliver therapeutic electrical pulses in parallel may provide redundancy that allows the pulse generator to continue delivering therapeutic electrical pulses as long as one capacitor has not failed and can deliver therapeutic electrical pulses.

[0024] In one or more embodiments, one or more capacitors may be arranged to be charged in parallel and to deliver therapeutic electrical pulses in series. The pulse generator may include an input terminal that is operatively coupled to a power source and configured to charge the one or more capacitors in parallel. The input terminal may include one or more switches to allow power to be received from the power source to charge the one or more capacitors. The input terminal may be controlled by a controller to charge the one or more capacitors. For example, the controller may be configured to open and close one or more switches at the input terminal. The switches at the input terminal may include, for example, one or more relays, transistors, digital switches, or other switching devices.

[0025] The pulse generator may also include an output terminal operatively coupled to one or more capacitors and configured to deliver therapeutic electrical pulses from the one or more capacitors. The output terminal may include one or more switches to allow the use of one or more capacitors to deliver therapeutic electrical pulses. The output terminal may be controlled by a controller to deliver the therapeutic electrical pulses. For example, the controller may be configured to open and close one or more switches at the output terminal. The switches at the output terminal may include, for example, one or more relays, transistors, digital switches, or other switching devices.

[0026] In one or more embodiments, the output can be static, such that therapeutic electrical pulses are delivered from the same arrangement of capacitors at all times. In other words, the output can be configured to deliver therapeutic electrical pulses from capacitors connected in series, in parallel, or a combination of series and parallel. In one or more other embodiments, the output can be dynamic, such that therapeutic electrical pulses can be delivered from different combinations and arrangements of one or more capacitors. In other words, the output can be configured to selectively deliver therapeutic electrical pulses from one or more capacitors connected in series, in parallel, or a combination of series and parallel.

[0027] For example, the output may include a plurality of switches that may be opened or closed in various arrangements to deliver therapeutic electrical pulses from one or more capacitors. In one or more embodiments, a series of gradually increasing therapeutic electrical pulses may be delivered by three capacitors. A series of gradually increasing therapeutic electrical pulses may include therapeutic electrical pulses delivered by three capacitors in parallel. A series of gradually increasing therapeutic electrical pulses may include another therapeutic electrical pulse delivered by two of the three capacitors in parallel with each other and a third of the three capacitors arranged in series with the two capacitors. A series of gradually increasing therapeutic electrical pulses may include yet another therapeutic electrical pulse delivered by the three capacitors in series. Although three capacitors are used as an example, it should be understood that various arrangements of two capacitors or four or more capacitors may also be utilized.

[0028] The one or more capacitors can have any suitable maximum voltage to provide the therapeutic electrical pulses. Each of the one or more capacitors can have a separate maximum voltage, which can be the same as or different from the separate maximum voltages of the other capacitors in the one or more capacitors. At least one of the one or more capacitors can have a maximum voltage of, for example, at least 100 volts, at least 300 volts, at least 1000 volts, at least 2000 volts, or any voltage therebetween. In one or more embodiments, at least one of the one or more capacitors can have a maximum voltage of at least 1000 volts.

[0029] The one or more capacitors may have any suitable capacitance for providing therapeutic electrical pulses. In other words, the nominal capacitance of the one or more capacitors may depend on the parameters of the therapeutic electrical pulses to be delivered. Each of the one or more capacitors may have a separate capacitance that may be the same as or different from the separate capacitances of the other capacitors in the one or more capacitors. At least one of the one or more capacitors may have, for example, a capacitance of at least 40 microfarads and no more than 300 farads, or any capacitance therebetween. In one or more embodiments, as viewed from the output of the pulse generator, the one or more capacitors may have a capacitance of at least 140 microfarads and no more than 160 microfarads. In other words, the total capacitance of the one or more capacitors may be at least 140 microfarads and no more than 160 microfarads, as viewed from the output of the pulse generator.

[0030] The one or more capacitors may have any suitable energy capacity to store energy and deliver the therapeutic electrical pulses. In other words, the nominal energy capacity of the one or more capacitors may depend on the parameters of the therapeutic electrical pulses to be delivered. Each of the one or more capacitors may have a separate energy capacity that may be the same as or different from the separate energy capacity of the other capacitors in the one or more capacitors. Generally speaking, the energy capacity of the one or more capacitors may be greater than the maximum energy of the therapeutic electrical pulses to be delivered. In other words, the total energy capacity of the one or more capacitors may exceed the maximum energy that the therapeutic electrical pulse delivery system or device is configured to deliver. The energy capacity of the one or more capacitors may be at least 10% greater, at least 15% greater, at least 20% greater, or at least 25% greater than the maximum energy of the therapeutic electrical pulses to be delivered.

[0031] The pulse generator can be configured to deliver therapeutic electrical pulses having any suitable energy level or voltage. Generally speaking, the pulse generator can be configured to deliver therapeutic electrical pulses having an energy of at least 2 joules and no greater than 85 joules. For wearable devices, such as vests, the pulse generator can be configured to deliver therapeutic electrical pulses having an energy of up to 200 joules or up to 300 joules. The pulse generator can be configured to deliver electrical pulses having a voltage of, for example, at least 100 volts, at least 300 volts, at least 1000 volts, at least 2000 volts, or any voltage therebetween. In one or more embodiments, the pulse generator can be configured to deliver electrical pulses having a voltage of at least 1000 volts. The pulse generator can include a boost converter to step up or increase the voltage received from the power source. The boost converter can be configured to increase the voltage received from the power source to the therapeutic pulse voltage. The output voltage of the boost converter can be adjustable based on the desired therapeutic pulse voltage. For example, the controller can be configured to adjust the output voltage of the boost converter based on the desired therapeutic pulse voltage.

[0032] The therapeutic electrical pulse delivery system may include a housing. The pulse generator may be disposed in the housing. In one or more embodiments, the housing may include a wearable device, such as, for example, a vest, a cuff, a headgear, etc. In one or more embodiments, the housing may include a vest. The therapeutic electrical pulse delivery system may include any suitable medical device. In one or more embodiments, an implantable medical device includes the therapeutic electrical pulse delivery system.

[0033] According to one aspect, a therapeutic pulse generator is provided. The therapeutic pulse generator may include an input, one or more capacitors, and an output. The input may be operably coupled to a power source. One or more capacitors may be coupled to the input to receive and store energy provided by the power source. The one or more capacitors may have an energy capacity at least 10% greater than the maximum energy of a therapeutic electrical pulse delivered by the therapeutic pulse generator. The output may be operably coupled to the one or more capacitors to deliver a therapeutic electrical pulse using the energy stored in the one or more capacitors.

[0034] The pulse generator can include any suitable number of capacitors. In one or more embodiments, the one or more capacitors are comprised of a single capacitor. The use of capacitors with higher energy capacity can allow a single capacitor to have the maximum voltage and capacitance to deliver the therapeutic electrical pulses at the desired voltage. The use of a single capacitor can allow the size and cost of the pulse generator to be reduced compared to devices and systems using multiple electrolytic capacitors.

[0035] Although the pulse generator can be composed of a single capacitor, an arrangement including multiple capacitors can allow for a variety of pulse generator arrangements and / or dynamic therapeutic electrical pulse delivery. One or more capacitors can be arranged to be charged in parallel and to deliver the therapeutic electrical pulses in parallel. In other words, each of the one or more capacitors can be arranged such that a terminal of each capacitor is coupled to a first voltage node and another terminal of each capacitor is coupled to a second voltage node. In one or more embodiments, the one or more capacitors can be arranged to be charged in parallel and to deliver the therapeutic electrical pulses in series.

[0036] The input terminal can be configured to charge one or more capacitors connected in parallel. The input terminal can include one or more switches to allow power to be received from a power source to charge the one or more capacitors. The input terminal can be controllable to charge the one or more capacitors. For example, the one or more switches can be opened or closed by a controller to control the charging of the one or more capacitors. The switches at the input terminal can include, for example, one or more relays, transistors, digital switches, or other switching devices.

[0037] The output can be configured to deliver therapeutic electrical pulses from one or more capacitors. The output can include one or more switches to allow the use of one or more capacitors to deliver therapeutic electrical pulses. The output can be controllable by a controller to deliver the therapeutic electrical pulses. For example, the one or more switches at the output can be opened or closed by the controller to control the delivery of the therapeutic electrical pulses. The switches at the output can include, for example, one or more relays, transistors, digital switches, or other switching devices.

[0038] In one or more embodiments, the output can be static, such that therapeutic electrical pulses are delivered from the same arrangement of capacitors at all times. In other words, the output can be configured to deliver therapeutic electrical pulses from capacitors connected in series, in parallel, or a combination of series and parallel. In one or more other embodiments, the output can be dynamic, such that therapeutic electrical pulses can be delivered from different combinations and arrangements of one or more capacitors. In other words, the output can be configured to selectively deliver therapeutic electrical pulses from one or more capacitors connected in series, in parallel, or a combination of series and parallel.

[0039] For example, the output may include a plurality of switches that may be opened or closed in various arrangements to deliver therapeutic electrical pulses from one or more capacitors. In one or more embodiments, a series of gradually increasing therapeutic electrical pulses may be delivered by three capacitors. A series of gradually increasing therapeutic electrical pulses may include a therapeutic electrical pulse delivered by three capacitors in parallel. A series of gradually increasing therapeutic electrical pulses may include another therapeutic electrical pulse delivered by two of the three capacitors in parallel with each other and a third of the three capacitors arranged in series with the two capacitors. A series of gradually increasing therapeutic electrical pulses may include yet another therapeutic electrical pulse delivered by the three capacitors in series. Although three capacitors are used as an example, it should be understood that various arrangements of two capacitors or four or more capacitors may also be utilized.

[0040] The one or more capacitors can have any suitable maximum voltage to provide the therapeutic electrical pulses. Each of the one or more capacitors can have a separate maximum voltage, which can be the same as or different from the separate maximum voltages of the other capacitors in the one or more capacitors. At least one of the one or more capacitors can have a maximum voltage of, for example, at least 100 volts, at least 300 volts, at least 1000 volts, at least 2000 volts, or any voltage therebetween. In one or more embodiments, at least one of the one or more capacitors can have a maximum voltage of at least 1000 volts.

[0041] The one or more capacitors may have any suitable capacitance for providing therapeutic electrical pulses. In other words, the nominal capacitance of the one or more capacitors may depend on the parameters of the therapeutic electrical pulses to be delivered. Each of the one or more capacitors may have a separate capacitance that may be the same as or different from the separate capacitances of the other capacitors in the one or more capacitors. At least one of the one or more capacitors may have, for example, a capacitance of at least 40 microfarads and no more than 300 farads, or any capacitance therebetween. In one or more embodiments, as viewed from the output of the pulse generator, the one or more capacitors may have a capacitance of at least 140 microfarads and no more than 160 microfarads. In other words, the total capacitance of the one or more capacitors may be at least 140 microfarads and no more than 160 microfarads, as viewed from the output of the pulse generator.

[0042] The one or more capacitors may have any suitable energy capacity to store energy and deliver the therapeutic electrical pulses. In other words, the nominal energy capacity of the one or more capacitors may depend on the parameters of the therapeutic electrical pulses to be delivered. Each of the one or more capacitors may have a separate energy capacity that may be the same as or different from the separate energy capacity of the other capacitors in the one or more capacitors. Generally speaking, the energy capacity of the one or more capacitors may be greater than the maximum energy of the therapeutic electrical pulses to be delivered. In other words, the total energy capacity of the one or more capacitors may exceed the maximum energy that the pulse generator is configured to deliver. The energy capacity of the one or more capacitors may be at least 10% greater, at least 15% greater, at least 20% greater, or at least 25% greater than the maximum energy of the therapeutic electrical pulses delivered by the pulse generator.

[0043] Figure 1 One embodiment of a therapeutic electrical pulse delivery system comprising a capacitor having excess energy capacity as described herein is depicted in . Figure 1 A conceptual diagram illustrating a therapeutic electrical pulse delivery system 100 in conjunction with a patient 10 is shown. Figure 1 As depicted, therapeutic electrical pulse delivery system 100 includes a housing 102 defining the exterior of an implantable medical device. Therapeutic electrical pulse delivery system 100 may be or may be included in any suitable implantable medical device, such as, for example, an implantable pulse generator, an implantable cardioverter-defibrillator, an implantable cardiac contractility modulator, an implantable neurostimulator, an implantable mechanical assist device, or the like.

[0044] The therapeutic electrical pulse delivery system 100 may also include one or more leads 104 to deliver the therapeutic electrical pulses to the desired treatment area of ​​the patient 10. The leads 104 may include one or more electrodes (not shown) to facilitate delivery of the therapeutic electrical pulses to the desired treatment area. In one or more embodiments, the therapeutic electrical pulse delivery system 100 may include one or more electrodes without any leads. For example, when the therapeutic electrical pulse delivery system 100 can be implanted at the desired treatment area, no leads may be required to deliver the therapeutic electrical pulses.

[0045] In addition to implantable medical devices, the therapeutic electrical pulse delivery system 100 may be, or may be housed in, a wearable or other non-implantable device. An example of a therapeutic electrical pulse delivery system 100 housed in a vest 103 is shown in FIG. Figure 2 Other wearable devices may include cuffs, skin patches, etc. When compared to therapeutic electrical pulse delivery systems using capacitors with little or no excess energy capacity, wearable therapeutic electrical pulse delivery systems using capacitors with excess energy capacity may have reduced charging time, increased charging efficiency, and longer life.

[0046] A schematic block diagram of the electronic components of the therapeutic electrical pulse delivery system 100 is shown in FIG. Figure 3 The electronic components of the therapeutic electrical pulse delivery system 100 may be disposed in a housing 102 for implantation into a patient 10, such as Figure 1 As shown, or provided in a wearable device such as Figure 2 The therapeutic electrical pulse delivery system 100 may include a power source 106, a pulse generator 108, and a controller 110.

[0047] The power source 106 can be operatively coupled to the pulse generator 108 to provide energy to charge the pulse generator 108. Generally, the power source 106 can be a voltage source. The power source 106 can be configured to provide energy at a voltage of at least 10 volts to no more than 2000 volts. Thus, the current provided by the power source 106 to the pulse generator 108 can vary based on the charge state of the pulse generator. The power source 106 can include any suitable energy storage and / or power delivery device. The power source 106 can include one or more, for example, batteries, electrochemical cells, fuel cells, supercapacitors, switches, controllers, battery management systems, or other energy storage and / or power delivery devices.

[0048] The pulse generator 108 may be operatively coupled to the power source 106. The pulse generator 108 may be configured to receive energy from the power source 106 within a nominal voltage range of the power source 106. A schematic block diagram of one embodiment of the pulse generator or therapy pulse generator 108 is shown in FIG. Figure 4. The pulse generator 108 may be operatively coupled or operatively coupled to the power source 106 via an input 112. The input 112 may include a switch to allow for control of the energy received from the power source 106. Alternatively, the input 112 may be operatively coupled to an external switch. The external switch may typically be part of the pulse generator 108 or included in the power source 106. The switch, whether internal or external to the pulse generator, may include any suitable device or devices. The switch may include, for example, one or more transistors, an electromechanical switch, a flip-flop, or the like.

[0049] The pulse generator 108 may include one or more capacitors 116. Each of the one or more capacitors 116 may include a first electrode, a second electrode, and a dielectric disposed between the first electrode and the second electrode. The one or more capacitors 116 may have an energy capacity greater than the maximum energy level of the therapeutic electrical pulses delivered by the therapeutic electrical pulse delivery system 100. For example, the therapeutic electrical pulse delivery system 100 may be configured to supply 35 joules to 40 joules of energy per delivered therapeutic electrical pulse, and the one or more capacitors 116 may have an energy capacity of at least 45 joules. In one or more embodiments, the one or more capacitors 116 may have an energy capacity that is at least 10% greater than the maximum energy of the therapeutic electrical pulses delivered by the electrical pulse delivery system. In one or more embodiments, the one or more capacitors 116 may have an energy capacity that is at least 20% greater than the maximum energy of the therapeutic electrical pulses delivered by the electrical pulse delivery system. In one or more embodiments, the one or more capacitors 116 may have an energy capacity that is at least 25% greater than the maximum energy of the therapeutic electrical pulses delivered by the electrical pulse delivery system.

[0050] The one or more capacitors 116 may have any suitable energy capacity to provide therapeutic electrical pulses at any suitable energy for a particular therapeutic electrical pulse delivery system. For example, some implantable therapeutic electrical pulse delivery systems can deliver up to 85 joules of therapeutic electricity. Thus, when the therapeutic electrical pulse delivery system 100 is or includes an implantable medical device, the one or more capacitors 116 may have an energy capacity in the range of at least 93.5 joules up to 106.25 joules. Further, for example, some wearable or external therapeutic electrical pulse delivery systems can deliver up to 300 joules of therapeutic electrical pulses. Thus, the one or more capacitors 116 may have an energy capacity in the range of at least 330 joules up to 375 joules. In one embodiment, the one or more capacitors 116 may have an energy capacity of at least 40 joules to no more than 50 joules.

[0051] The pulse generator 108 may include an output 118 operatively coupled to one or more capacitors to deliver therapeutic electrical pulses using energy stored in the one or more capacitors. The output 118 may include a switch to allow control of the delivery of therapeutic electrical pulses from the one or more capacitors 116. The switch may include any suitable device or devices for controlling the delivery of therapeutic electrical pulses. The switch may include, for example, one or more transistors, an electromechanical switch, a flip-flop, or the like.

[0052] The pulse generator 108 may also include a boost converter 114. The boost converter 114 may be configured to increase the voltage of the energy received from the power source 106. In one or more embodiments, the output voltage of the power source 106 may be lower than the desired voltage for delivering the therapeutic electrical pulses. In such embodiments, the boost converter 114 may increase the voltage provided by the power source 106. In one or more embodiments, the boost converter 114 may be adjustable to allow the pulse generator 108 to deliver therapeutic electrical pulses at various voltages. For example, the boost converter 114 may be configured to adjust the output voltage based on a command or signal received from the controller 110. The boost converter 114 may include any suitable one or more devices for boosting or increasing the voltage provided by the power source 106. The boost converter 114 may include, for example, one or more of a direct current (DC)-DC converter, a switch, a transistor, a transformer, an inductor, and the like.

[0053] The energy transfer from the power source 106 to the pulse generator 108 can be controlled by a controller 110. The controller 110 can be operatively coupled to the power source 106 and / or the pulse generator 108. The controller 110 can be configured to charge one or more capacitors 116 of the pulse generator 108 using the power source 106 and cause the pulse generator 108 to deliver therapeutic electrical pulses using the charged one or more capacitors 116. To charge the one or more capacitors 116, the controller 110 can be configured to close a switch associated with the input 112 and / or the power source 106 to allow current to flow from the power source 106 to the pulse generator 108. To deliver the therapeutic electrical pulses, the controller 110 can be configured to close a switch associated with the output 118 of the pulse generator 108. Additionally, the controller 110 can be configured to open the switch at the input 112 or the power source 106 before closing the switch at the output 118. When the switch of output 118 is closed, energy stored in capacitor 116 may flow through the output to one or more leads / electrodes 104 and ultimately to a therapy delivery site in patient 10 .

[0054] The controller 110 may include any suitable analog or digital circuitry to charge the one or more capacitors 116 and deliver the therapeutic electrical pulses. The controller may include, for example, one or more processors, logic gates, operational amplifiers, transistors, analog-to-digital converters, sensors, or other circuits or devices that control the power source 106 and / or the pulse generator 108. The controller 110 may include a data storage device for data storage and access to processing programs or routines that may be used to implement techniques, processes, and algorithms for charging the one or more capacitors 116 and delivering the therapeutic electrical pulses. For example, the processing programs or routines may include programs or routines for pulse delivery timing, pulse delivery triggering, opening and closing switches, determining output voltage, adjusting output voltage, filtering background noise, computational mathematics, matrix mathematics, Fourier transforms, compression algorithms, calibration algorithms, inversion algorithms, signal processing algorithms, normalization algorithms, deconvolution algorithms, averaging algorithms, standardization algorithms, comparison algorithms, vector mathematics, or any other processing necessary to implement one or more embodiments as described herein.

[0055] The controller 110 may also include a communication interface for communicating with one or more external devices. The communication interface may include any suitable hardware or device that provides wired or wireless communication with one or more external devices. For example, the communication interface may include one or more of a receiver, a transmitter, a transceiver, an Ethernet port, a universal serial bus (USB) port, a cable, a controller, or other devices that facilitate wired or wireless communication. The communication interface may use any suitable one or more protocols to facilitate communication. For example, the communication interface may utilize Ethernet, Recommended Standard 232, a universal asynchronous receiver transmitter or a universal synchronous asynchronous receiver transmitter (UART / USART), USB, Bluetooth, Wi-Fi, near field communication (NCF), etc. The communication interface may allow communication between the therapeutic electrical pulse delivery system 100 and a computing device.

[0056] The present invention is defined in the claims. However, a non-exhaustive list of non-limiting examples is provided below. Any one or more of the features of these examples may be combined with any one or more features of another example, embodiment, or aspect described herein.

[0057] Example Ex1: A therapeutic electrical pulse delivery system for delivering therapeutic electrical pulses, the therapeutic electrical pulse delivery system comprising: a power source; a pulse generator operatively coupled to the power source, the pulse generator comprising one or more capacitors for storing and delivering energy, the one or more capacitors having an energy capacity at least 10% greater than the maximum energy of the therapeutic electrical pulses delivered by the therapeutic electrical pulse delivery system; and a controller comprising one or more processors and operatively coupled to the power source or the pulse generator, the controller being configured to: charge the one or more capacitors of the pulse generator using the power source; and cause the pulse generator to deliver the therapeutic electrical pulses using the charged one or more capacitors.

[0058] Example Ex2: A therapeutic electrical pulse delivery system according to Example Ex1, wherein the pulse generator further comprises: an input end, which is operatively coupled to the power source and configured to charge the one or more capacitors in parallel; and an output end, which is operatively coupled to the one or more capacitors and configured to selectively deliver the therapeutic electrical pulses from the one or more capacitors in series, parallel, or a combination of series and parallel.

[0059] Embodiment Ex3: The therapeutic electrical pulse delivery system according to any one of the preceding embodiments, wherein the one or more capacitors consists of a single capacitor.

[0060] Embodiment Ex4: The therapeutic electrical pulse delivery system according to any one of the preceding embodiments, wherein the one or more capacitors have a maximum energy capacity of at least 40 joules and no greater than 50 joules.

[0061] Embodiment Ex5: The therapeutic electrical pulse delivery system according to any one of the preceding embodiments, wherein the pulse generator is configured to deliver the therapeutic electrical pulse having at least 30 joules and no greater than 40 joules.

[0062] Embodiment Ex6: The therapeutic electrical pulse delivery system according to any one of the preceding embodiments, wherein the one or more capacitors have an energy capacity that is at least 20% greater than the maximum energy of the therapeutic electrical pulse delivered by the therapeutic electrical pulse delivery system.

[0063] Embodiment Ex7: The therapeutic electrical pulse delivery system according to any one of the preceding embodiments, further comprising a housing, wherein the pulse generator is disposed in the housing.

[0064] Embodiment Ex8: The therapeutic electrical pulse delivery system of embodiment Ex7, wherein the housing comprises a vest.

[0065] Example Ex9: A therapeutic pulse generator for delivering therapeutic electrical pulses, the therapeutic pulse generator comprising: an input end, which is capable of being operably coupled to a power source; one or more capacitors, which are used to store and deliver energy, and the one or more capacitors have an energy capacity that is at least 10% greater than the maximum energy of the therapeutic electrical pulses delivered by the therapeutic pulse generator; and an output end, which is operably coupled to the one or more capacitors to deliver therapeutic electrical pulses using the energy stored in the one or more capacitors.

[0066] Example Ex10: A therapeutic pulse generator according to Example Ex9, wherein the input end is configured to charge the one or more capacitors in parallel, and the output end is configured to selectively deliver the therapeutic electric pulses from the one or more capacitors in series, parallel, or a combination of series and parallel.

[0067] Embodiment Ex11: The therapeutic pulse generator according to any one of embodiments Ex9 or Ex10, wherein the one or more capacitors consist of a single capacitor.

[0068] Embodiment Ex12: The therapeutic pulse generator according to any one of Embodiments Ex9 or Ex11, wherein the one or more capacitors include a plurality of capacitors in a stacked arrangement.

[0069] Embodiment Ex13: The therapeutic pulse generator according to any one of Embodiments Ex9 to Ex12, wherein the one or more capacitors have a maximum energy capacity of 40 joules and no greater than 50 joules.

[0070] Embodiment Ex14: The therapeutic pulse generator according to any one of Embodiments Ex9 to Ex13, wherein the pulse generator is configured to deliver the therapeutic electrical pulses having at least 30 joules and no greater than 40 joules.

[0071] Embodiment Ex15: The therapeutic pulse generator according to any one of Embodiments Ex9 to Ex15, wherein the one or more capacitors have an energy capacity that is at least 20% greater than the maximum energy of the therapeutic electrical pulses delivered by the therapeutic pulse generator.

[0072] Embodiment Ex16: According to any one of embodiments Ex9 to Ex15, the therapeutic pulse generator further includes a boost converter, which is operatively coupled to the input terminal and the one or more capacitors to boost the voltage received from the power source.

[0073] Example Ex17: An implantable medical device for delivering therapeutic electrical pulses, the implantable medical device comprising: a housing suitable for being implanted in a patient; a power source disposed in the housing; a pulse generator operatively coupled to the power source, the pulse generator comprising one or more capacitors for storing and delivering energy, the one or more capacitors having an energy capacity at least 10% greater than the maximum energy of the therapeutic electrical pulses delivered by the implantable medical device; and a controller comprising one or more processors and operatively coupled to the power source or the pulse generator, the controller being configured to: charge the one or more capacitors of the pulse generator using the power source; and cause the pulse generator to deliver the therapeutic electrical pulses using the charged one or more capacitors.

[0074] Example Ex18: An implantable medical device according to Example Ex17, wherein the pulse generator further comprises: an input end, which is operatively coupled to the power source and configured to charge the one or more capacitors in parallel; and an output end, which is operatively coupled to the one or more capacitors and configured to selectively deliver the therapeutic electrical pulses from the one or more capacitors in series, parallel, or a combination of series and parallel.

[0075] Embodiment Ex19: The implantable medical device of embodiment Ex17 or Ex18, wherein the one or more capacitors consist of a single capacitor.

[0076] Embodiment Ex20: The implantable medical device of any one of Embodiments Ex17 to Ex19, wherein the one or more capacitors have a maximum energy capacity of at least 40 Joules and no greater than 50 Joules.

[0077] Embodiment Ex21: The implantable medical device according to any one of Embodiments Ex17 or Ex20, wherein the pulse generator is configured to deliver the therapeutic electrical pulses having at least 30 joules and no greater than 40 joules.

[0078] Embodiment Ex22: An implantable medical device according to any one of Embodiments Ex17 or Ex21, wherein the one or more capacitors have an energy capacity at least 20% greater than the maximum energy of the therapeutic electrical pulses delivered by the implantable medical device.

[0079] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense, including "and / or," unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0080] Unless otherwise expressly stated, it is not intended that any method described herein be construed as requiring that its steps be performed in a specific order. Therefore, if a method claim does not actually recite the order in which its steps are to be followed, or if the steps are not otherwise specifically stated in the claims or specification to be limited to a specific order, no specific order is intended to be inferred. Any recited feature or features or aspects in any claim may be combined or substituted with any other recited feature or aspect in any other claim or claims.

[0081] It will be apparent to those skilled in the art that various modifications and variations can be made to the technology of the present invention without departing from the spirit and scope of the present disclosure. Since those skilled in the art can make modifications, combinations, sub-combinations and variations of the disclosed embodiments that incorporate the spirit and substance of the technology of the present invention, the technology of the present invention should be interpreted as including all things within the scope of the appended claims and their equivalents.

Claims

1. A therapeutic electrical pulse delivery system for delivering therapeutic electrical pulses, the therapeutic electrical pulse delivery system comprising: Power source; a pulse generator operatively coupled to the power source, the pulse generator comprising one or more capacitors for storing and delivering energy, the one or more capacitors having an energy capacity at least 10% greater than a maximum energy of a therapeutic electrical pulse delivered by the therapeutic electrical pulse delivery system; and a controller comprising one or more processors and operatively coupled to the power source or the pulse generator, the controller being configured to: charging the one or more capacitors of the pulse generator using the power source; as well as The pulse generator is caused to deliver therapeutic electrical pulses using the charged one or more capacitors.

2. The therapeutic electrical pulse delivery system of claim 1 , wherein the pulse generator further comprises: an input operatively coupled to the power source and configured to charge the one or more capacitors in parallel; and An output is operatively coupled to the one or more capacitors and configured to selectively deliver the therapeutic electrical pulses from the one or more capacitors in series, parallel, or a combination of series and parallel.

3. The therapeutic electrical pulse delivery system of claim 1 or 2, wherein the one or more capacitors consist of a single capacitor.

4. The therapeutic electrical pulse delivery system of any one of claims 1 to 3, wherein the one or more capacitors have an energy capacity that is at least 20% greater than the maximum energy of the therapeutic electrical pulses delivered by the therapeutic electrical pulse delivery system.

5. The therapeutic electrical pulse delivery system according to any one of claims 1 to 4, further comprising a housing, wherein the pulse generator is disposed in the housing.

6. A therapeutic pulse generator for delivering therapeutic electrical pulses, the therapeutic pulse generator comprising: an input operatively coupled to a power source; one or more capacitors for storing and delivering energy, the one or more capacitors having an energy capacity at least 10% greater than a maximum energy of therapeutic electrical pulses delivered by the therapeutic pulse generator; and An output operatively coupled to the one or more capacitors for delivering therapeutic electrical pulses using energy stored in the one or more capacitors.

7. A therapeutic pulse generator according to claim 6, wherein the input end is configured to charge the one or more capacitors in parallel, and the output end is configured to selectively deliver the therapeutic electrical pulses from the one or more capacitors in series, parallel, or a combination of series and parallel.

8. The therapeutic pulse generator according to claim 6 or 7, wherein the one or more capacitors consist of a single capacitor.

9. The therapeutic pulse generator of claim 6 or 7, wherein the one or more capacitors comprise a plurality of capacitors arranged in a stack.

10. The therapeutic pulse generator according to any one of claims 6 to 9, further comprising a boost converter operatively coupled to the input terminal and the one or more capacitors to boost the voltage received from the power source.

11. An implantable medical device for delivering therapeutic electrical pulses, the implantable medical device comprising: a housing adapted to be implanted in a patient; a power source, the power source being disposed in the housing; a pulse generator operatively coupled to the power source, the pulse generator comprising one or more capacitors for storing and delivering energy, the one or more capacitors having an energy capacity at least 10% greater than a maximum energy of therapeutic electrical pulses delivered by the implantable medical device; and a controller comprising one or more processors and operatively coupled to the power source or the pulse generator, the controller being configured to: charging the one or more capacitors of the pulse generator using the power source; as well as The pulse generator is caused to deliver therapeutic electrical pulses using the charged one or more capacitors.

12. The implantable medical device of claim 11 , wherein the pulse generator further comprises: an input operatively coupled to the power source and configured to charge the one or more capacitors in parallel; and An output is operatively coupled to the one or more capacitors and configured to selectively deliver the therapeutic electrical pulses from the one or more capacitors in series, parallel, or a combination of series and parallel.

13. The implantable medical device of claim 11 or 12, wherein the one or more capacitors consist of a single capacitor.

14. The implantable medical device of any one of claims 11 to 13, wherein the one or more capacitors have an energy capacity that is at least 20% greater than the maximum energy of the therapeutic electrical pulses delivered by the implantable medical device.

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