CN107847753B

CN107847753B - Novel biphasic or multiphasic pulse generator and method

Info

Publication number: CN107847753B
Application number: CN201680028694.7A
Authority: CN
Inventors: D.M.雷蒙; P.D.格雷
Original assignee: Cardio Thrive Inc
Current assignee: Cardio Thrive Inc
Priority date: 2015-03-18
Filing date: 2016-03-18
Publication date: 2022-02-08
Anticipated expiration: 2036-03-18
Also published as: CA2980000A1; CN107847753A; EP3271010A1; HK1253039A1; WO2016149617A1; EP3271010A4; KR20170129865A; AU2016232837A1; AU2016232837B2; JP2018508313A

Abstract

A dynamically adjustable biphasic or multiphasic pulse generation system and method are provided. A dynamically adjustable biphasic or multiphasic pulse generator system may be used as a pulse generation system for a defibrillator or other type of electrically stimulated medical device.

Description

Novel biphasic or multiphasic pulse generator and method

Priority statement/related application

This application is in part a continuation of U.S. patent application Ser. No. 14/303,541 filed on 12.6.2014 And entitled "DYNAMICALLY ADASTABLE Multiphasic Defibrillator Pulse System And Method" And entitled to priority thereof according to U.S. code volume 35, item 120, which U.S. patent application Ser. No. 14/303,541 in turn entitled to priority of U.S. provisional patent application Ser. No. 61/835,443 filed on 14.6.2013 according to U.S. code volume 35, item 120 And entitled "DYNAMICALLY ADASTABLE Multiphasic Defibrillator Pulse System And Method" And entitled to the benefit thereof according to U.S. code volume 35, item 119 (e), all of which are incorporated herein by reference in their entirety.

Technical Field

The present disclosure relates to medical devices, and in particular, to devices and methods of generating and delivering therapeutic treatment pulses for use in medical devices, such as cardioverters and defibrillators, neurostimulators, musculoskeletal stimulators, organ stimulators, and neurostimulators. More particularly, the present disclosure relates to the generation of new and innovatively shaped biphasic or multiphasic pulse waveforms by such medical devices.

Background

It is well known that signals having waveforms may have therapeutic benefits when applied to a patient. For example, the therapeutic benefit to the patient may be the treatment provided to the patient. The therapeutic benefit or therapeutic treatment may include stimulation of a portion of the patient's body or treatment of cardiac arrest of the patient. Existing systems that apply signals having waveforms to a patient typically generate and apply well-known signal waveforms and do not provide much or any adjustability or variability of the signal waveforms.

In the context of defibrillators or cardioverters, manual defibrillators today deliver older versions of monophasic pulses (single high energy single polarity pulse) or biphasic pulses (including an initial positive high energy pulse followed by a smaller negative inverted pulse) that are now more common. Today's implantable cardioverter-defibrillators (ICDs), Automated External Defibrillators (AEDs), and wearable cardioverter-defibrillators (WCDs) all deliver biphasic pulses with various pulse phase lengths, high initial starting pulse amplitudes, and various pulse slopes. Each manufacturer of a particular defibrillator, for commercial reasons, has its own unique and slightly different precise timing and shape of biphasic pulses for the pulses of its device, although they are all designed based on a standard biphasic waveform. Various clinical studies during the past decades have indicated that the use of these variations of biphasic waveforms has greater therapeutic value for patients requiring defibrillation therapy than older monophasic waveforms, and that these standard biphasic waveforms are effective at significantly lower energy delivery levels than the original monophasic waveforms and have a higher resuscitation success rate with respect to first shock delivery.

Thus, almost all current defibrillator products that use biphasic waveform pulses have a single high-energy reservoir, which, while simple and convenient, results in severe limitations with respect to the range of variable pulse shapes that can be delivered. Specifically, the second (or negative) phase of the biphasic waveform is characterized rather previously by a lower amplitude onset than the first (or positive) phase of the biphasic waveform, as shown in fig. 4. This is due to the following: during the initial positive phase of delivery, a portion of the high energy reservoir is expended, then, after reversing the polarity of the waveform so that a negative phase can be delivered, there is only the same partially expended amount of energy remaining in the energy reservoir. This lower amplitude onset constrains and results in a lower initial amplitude for the negative phase of the waveform. A typical exponentially decaying discharge is shown by the positive phase of the waveform shown in fig. 4.

Standard biphasic pulse waveforms have been commonly used in manual defibrillators and AEDs since the mid-90 s of the 20 th century, and still result in energy levels at any one point from 120 to 200 joules or more being delivered to the patient in order to be effective. This results in very high current levels through the patient over a short period of time, which can cause skin and flesh damage in the form of burns at the site of the electrode pads or paddles, in addition to the possibility of damage to organs deeper within the patient's body, including the heart itself. The significant amount of energy used for each impact and the large number of impacts these AED devices are designed to be able to deliver during their uptime have also limited the ability to further shrink the size of the device.

WCDs generally need to deliver an impact of 150-200 joules in order to be effective, and this creates a lower limit on the required size of the electrical components and batteries, and thus affects the overall size of the device and the level of comfort for the patient wearing it.

ICDs, given that they are implanted in the body of a patient, must be able to last as many years as possible before their batteries are depleted and they have to be replaced with new units by surgery. ICDs typically deliver biphasic shocks up to a maximum of 30-45 joules, which is lower than that required for effective external defibrillation because the device is in direct contact with the patient's cardiac tissue. Subcutaneous ICDs differ slightly in that they are not in direct contact with the patient's heart, and these typically deliver a biphasic shock of 65-80 joules in order to be effective. Even at these lower energy levels, there is significant pain caused to the patient if the impact is delivered by the device incorrectly. Most existing devices are designed to last between 5-10 years before their batteries are depleted and they need to be replaced.

Another equally common type of defibrillator is an Automated External Defibrillator (AED). Rather than being implanted, an AED is an external device used by a third party to resuscitate a person suffering from cardiac arrest. Fig. 9 illustrates a conventional AED 800, which includes a base unit 802 and two pads 804. Sometimes a slurry with a handle is used instead of pad 804. The pads 804 are connected to the base unit 802 using electrical cables 806.

A typical protocol for using the AED 800 is as follows. Initially, a person suffering from cardiac arrest is placed on the floor. The clothing is removed to reveal the person's chest 808. Pad 804 is applied to the appropriate location on chest 808, as illustrated in fig. 9. The electrical system within the base unit 802 generates a high voltage between the two pads 804 that delivers an electrical impact to the person. Ideally, the shock restores normal heart rhythm. In some cases, multiple impacts are required.

Drawings

FIG. 1 illustrates a medical device having a biphasic or multiphasic waveform generator;

FIG. 2 illustrates a defibrillator medical device having a multiphasic waveform generator with multiple independent subsystems, each with its own energy reservoir and energy source;

FIG. 3 illustrates a defibrillator medical device having a biphasic waveform generator with two independent subsystems, each with its own energy reservoir and energy source;

FIG. 4 illustrates a standard biphasic pulse waveform in which the second (negative) phase of the waveform is smaller in amplitude than the amplitude of the first (positive) phase of the waveform;

5A, 5B, and 5C illustrate different examples of novel biphasic or multiphasic pulse waveforms generated by a biphasic or multiphasic waveform generator, wherein the second (negative) phase of the waveform is greater in amplitude than the amplitude of the first (positive) phase of the waveform;

FIG. 6 illustrates an embodiment of a bi/multiphase waveform generator having a single circuit containing multiple energy reservoirs that can be dynamically charged and then discharged through an H-bridge from a single energy source, respectively;

FIG. 7 illustrates a bi/multiphase waveform generator with a single circuit containing multiple energy reservoirs that can be individually dynamically charged and then discharged through an H-bridge;

FIG. 8 illustrates a circuit for adjusting the capacitance of a bi-or multi-phase waveform generator system;

fig. 9 diagrammatically illustrates an example of a conventional external defibrillator; and

fig. 10 illustrates a circuit for adjusting the resistance/impedance of the waveform generator system.

Detailed Description

The present disclosure is applicable to a variety of medical devices, including all defibrillator types: external (manual, semi-automated, and fully automated), wearable, implantable, and subcutaneously implantable. In addition to defibrillators, the medical devices may also be cardioverters and external/internal pacemakers, as well as other types of electrically stimulating medical devices, such as: neurostimulators, musculoskeletal stimulators, organ stimulators, and nerve/peripheral nerve stimulators, whether external or implanted. The novel biphasic or multiphasic waveform generator may be particularly useful for any type of defibrillator, and for purposes of illustration, examples of the novel biphasic or multiphasic waveform generator system will be described in the context of a defibrillator. However, it will be appreciated that the novel biphasic or multiphasic waveform generator may generate and deliver a much wider range of waveforms than has previously been possible in the art (or as shown in the examples), including a new generation/family of novel biphasic or multiphasic waveforms, as shown in fig. 5A, 5B, and 5C. Thus, the novel biphasic or multiphasic waveform generator has greater utility with existing devices as it can be used to generate one or more of the novel lower energy biphasic pulses of the family. For example, the novel biphasic or multiphasic pulse generator may be configured to generate and deliver a wide variety of new low energy biphasic or multiphasic waveforms with varying pulse timing, phase tilt, and amplitude. Such waveforms may be used in various medical devices as described above. In these devices, a pulse generator system may be used to generate therapeutic treatment pulses and then provide the pulses to a patient using a paddle or pad or other suitable form of electrode.

The novel biphasic or multiphasic waveform generator may be embodied in many different ways to constitute a range of different potential circuit designs, all of which are within the scope of the present disclosure, as any of the circuit designs will be capable of generating and delivering a wide variety of biphasic and/or multiphasic waveforms, including a new family/generation of low energy biphasic and/or multiphasic waveforms, wherein a first phase of the waveform has a lower amplitude than a second phase of the waveform.

Fig. 1 illustrates a medical device system 100 having a novel biphasic or multiphasic waveform generator 104. As described above, the medical device system may be any type of defibrillator system or any of the other types of medical devices described above. The medical device system 100 may include a medical device 102 that generates and delivers a novel biphasic or multiphasic pulse waveform 110 to a patient 112. The novel biphasic or multiphasic pulse waveform 110 may be a therapeutic pulse, a defibrillation pulse, or the like. As shown in fig. 1, the medical device 102 may include a novel multiphase or biphasic waveform generator 104, an energy source 106, and control logic 108. The novel multiphasic or biphasic waveform generator 104 may use the energy stored/generated by the energy source 106 to generate the novel biphasic or multiphasic pulse waveform 110.

The novel biphasic or multiphasic pulse waveform 110 may have one or more first phases and one or more second phases, where the first and second phases may be of opposite polarity. In one biphasic waveform example, the first phase may be a positive phase, the second phase may be a negative phase, and the second phase of the waveform may be greater in amplitude than the amplitude of the first phase of the waveform, as shown in fig. 5A and 5B. Additionally, as shown in fig. 5C, a novel multiphasic pulse waveform is shown that may be generated by the multiphasic or biphasic waveform generator 104, where the biphasic or multiphasic pulse waveform 110 has more than one first phase and more than one second phase of the pulse waveform. In the example in fig. 5C, each first phase has a positive polarity and each second phase has a negative polarity. For example, the amplitude of the second phase may be less than 2500 volts and the first phase will be less than the second phase. The multiphasic or biphasic waveform generator 104 may deliver between 0.1 and 200 joules of energy to the patient during the first and second phases of the generated pulse waveform and the inter-pulse period between the first and second phases. The multiphase or biphasic waveform generator 104 may deliver a waveform to the patient during a 2ms to 20ms time period.

The control logic unit 108 may be coupled to and/or electrically connected to the multiphasic or biphasic waveform generator 104 and the energy source 106 to control each of those components to generate various versions of the biphasic or multiphasic pulse waveform 110. Energy source 106 may be one or more power sources and one or more energy reservoirs. The control logic unit 108 may be implemented in hardware. For example, the control logic 108 may be a plurality of lines of computer code that may be executed by a processor that is part of the medical device. The plurality of lines of computer code may be executed by a processor such that the processor is configured to control the multiphasic or biphasic waveform generator 104 and the energy source 106 to generate the biphasic or multiphasic pulse waveform 110. In another embodiment, the control logic unit 108 may be a programmable logic device, an application specific integrated circuit, a state machine, a microcontroller, which then controls the multiphase or biphasic waveform generator 104 and the energy source 106 to generate the biphasic or multiphasic pulse waveform 110. When the high voltage switch assembly 109 is part of the control logic unit 108, the control logic unit may also include analog or digital switching circuitry.

As shown in fig. 1, one or more patient contact devices may be used to deliver a biphasic or multiphasic pulse waveform 110 to a patient 112. The one or more patient contact devices can be, for example, electrodes, leads, pastes, pads, or anything else capable of delivering a biphasic or multiphasic pulse waveform 110 to the patient 112. To further illustrate the medical device having the multiphasic or biphasic waveform generator 104 and the energy source 106, an example of a defibrillator having the multiphasic or biphasic waveform generator 104 and the energy source 106 will now be described in more detail.

Fig. 2 illustrates a defibrillator medical device 10 having a multi-phase waveform generator with multiple independent subsystems each having its own energy reservoir and energy source, and fig. 3 illustrates a defibrillator medical device 10 having a biphasic waveform generator with two independent subsystems each having its own energy reservoir and energy source. In the novel multiphase or biphasic waveform generator 104 and energy source 106 embodiment, the assembly may employ two or more physically and electrically

distinct subsystems

12, 14, each having a waveform generator 104, an energy source 106, and control logic 108, as shown in fig. 2-3. The storage of stored electrical energy may be in two or more different circuits (see fig. 2 and 3) that function together in a coordinated manner to generate and deliver a pulse waveform, where each phase of the waveform results from a separate storage of stored energy. The energy reservoirs may be of the same size/number or otherwise of widely different sizes and may be supplied by one or more energy sources.

Energy source 106 is not limited to any particular number of energy reservoirs (such as capacitors) or energy sources (such as batteries). Thus, the medical device system 10 may have a plurality or "n" number (as many as desired) of

subsystems

12, 14 that together may be used to generate various multiphasic or biphasic waveforms. In the example embodiment shown in fig. 2 and 3, there may be two sides, such as side a and side B as shown, and each side may have one or more of the

subsystems

12, 14, and each subsystem may generate phases of a pulse waveform to generate a biphasic or multiphasic waveform having one or more first phases and one or more second phases. The two or

more subsystems

12, 14 permit the system to shape various characteristics of the first and second phases separately from one another. For example, in one example, a first phase may have a positive polarity and its characteristics may be shaped independently of a second phase and its characteristics, which may have a negative polarity. The above described functionality may be achieved through the use of a fast switching high energy/voltage switching system as described below. The fast switching high energy/voltage switching system 109 may be part of the control logic unit 108 or the generator 104.

Each

subsystem

12, 14 of each side, as shown in fig. 2 and 3, may have a control logic and rhythm sensing component 108 (which is connected to a similar component on the other side, as shown in fig. 2 and 3, by a digital control link 30), which control logic and rhythm sensing component 108 may also be coupled to a high voltage switching system component 109. The high voltage switching system component 109 may be implemented using analog circuitry or digital circuitry or even some mix of the two schemes. Additionally, the high voltage switching system assembly 109 may be implemented through the use of mechanical or solid state switches, or a combination of both. The energy storage may also be coupled to the other side of the system by a high voltage return line 32, as shown in fig. 2 and 3. The high voltage return 32 electrically completes the circuit and is present in existing defibrillators, but in a slightly different form because in the existing version of the device it is split into two parts in the form of two leads going from the main defibrillator device to the internal or external surface of the patient.

Fig. 5A-5C illustrate examples of biphasic or multiphasic waveforms that may be generated by the systems shown in fig. 2-3 and the systems shown in fig. 6-8. In the example in fig. 5A-5B, the first phase may be positive and the second phase may be negative. However, the biphasic or multiphasic waveform may also have a negative first pulse and a positive second pulse. As shown in fig. 5A and 5B, the first phase pulse amplitude may be less than the second phase amplitude. FIG. 5C illustrates a multiphase waveform in which the waveform has two or more positive polarity phases and two or more negative polarity phases.

In another embodiment (see fig. 6), the system 10 utilizes two or more reservoirs of stored electrical energy 501 (such as high voltage generator and reservoir 1061, high voltage generator and reservoir 1062, and high voltage generator and reservoir 106 n) that are statically or dynamically allocated from within the single circuit 502 and that act together in a coordinated manner to generate and deliver a final waveform, where each phase of the waveform is produced from a separate reservoir of stored energy. The energy reservoirs 501 may be of the same size/number or otherwise of widely different sizes and may be supplied by one or more energy sources. The system 10 may also have a high voltage switch 109 and an H-bridge switch 110 for each reservoir 501, which may be part of the control logic unit 108 or the generator 104. The H-bridge circuit is a known electronic circuit that enables a voltage to be applied across the load M in either direction using one or more switches (see http:// cp. lithium. agilent. com/litweb/pdf/5989-.

In another embodiment (see fig. 7), the system utilizes at least one storage 601 of stored electrical energy, configured as follows: the configuration divides from within a single circuit and statically or dynamically allocates into two or more portions of stored energy 602 and generates and delivers a final waveform in a coordinated fashion, where each phase of the waveform results from a separate portion of the stored energy. The portions of energy 602 may be of the same size/quantity or otherwise of widely different sizes and may be supplied by one or more energy sources. Essentially, this involves charging one or more groups/arrays of capacitors (the number of capacitors in a statically or dynamically created group is based on the voltage and energy requirements for the phases of the waveform or the waveform to be generated and delivered), and then discharging a select number of capacitors in the group that are configured as needed to provide the desired waveform or phases of the waveform. The charging and discharging of capacitors in parallel and series is well known in the art. By the configuration of the switches (mechanical or solid state), one can disconnect a certain number of capacitors from the original group/array of capacitors, thus splitting the stored energy into two (or more) parts/reservoirs feeding the H-bridge switch 110, allowing the creation of a wide variety of waveform phases with different amplitudes, shapes and timing.

Another embodiment of the system utilizes a direct current generation source to generate an initial phase of the waveform and then uses one or more reservoirs of stored electrical energy to generate a second phase of the waveform and any additional phases of the waveform. The energy storage used may be supplied by one or more energy sources.

Another embodiment of the system utilizes a direct current generation source to generate an initial phase of the waveform and then uses one or more additional direct current generation sources configured separately, together or otherwise in combination with a storage of stored electrical energy, to generate a second phase of the waveform and any additional phases of the waveform. The energy storage used may be supplied by one or more energy sources.

In additional embodiments, the pulse generator may be configured with the circuitry, processors, programming, and other control mechanisms necessary to separate and individually vary phase timing, inter-phase pulse timing(s), phase tilt, and phase amplitude, necessary to customize and optimize the waveform for the patient at hand and for the particular therapeutic purpose for which the waveform is being used.

The above described functions may be achieved by the use of a fast switching high energy/voltage switching system 109, which fast switching high energy/voltage switching system 109 may be analog or digital in nature or even some mix of the two schemes, as shown in fig. 2 and 3. Switching may be achieved through the use of mechanical or solid state switches or a combination of both.

Other embodiments of the system discharge portions of the initial phase energy of the waveform (see fig. 10) through the use of statically or dynamically assigned groups of resistive power dividers that step down the initial phase amplitude of the waveform across the groups of resistors and in this manner deliver a smaller remaining amplitude of the initial phase of the waveform to the patient while still delivering the full amplitude of the second phase (and any additional phases) to the patient.

Many embodiments of the system may utilize one or more additional circuit modules or subsystems intended to alter the RC constant of the pulse delivery circuit for one or more of the pulse phases, and thus alter the tilt of the phase of the pulse waveform involved. These modules or subsystems may include capacitor arrays or resistor arrays, or a combination of both (see fig. 8 and 10).

In some embodiments of the system, the system may provide recharging of each energy reservoir by the energy source during times when the individual energy reservoir is not selected for discharge (including inter-phase pulse times). This provides the opportunity to interleave the initial polyphase pulses of equal amplitude with several different high energy reservoirs.

Although the foregoing has been with reference to a particular embodiment of the disclosure, it will be appreciated by those skilled in the art that changes in this embodiment may be made without departing from the principles and spirit of the disclosure, the scope of which is defined by the appended claims.

Claims

1. A pulse generator, comprising:

a pulse waveform generator that generates a pulse waveform having at least one first phase of the pulse waveform and at least one second phase of the pulse waveform, wherein the first phase has an amplitude that is less than an amplitude of the second phase, and wherein the first phase has a polarity and the second phase has an opposite polarity to the first phase;

at least a first subsystem generating at least a first phase of the pulse waveform, the subsystem having a power source, an energy storage, and an adjustment component that adjusts a slope of the first phase of the pulse waveform or an amplitude of the first phase of the pulse waveform;

at least a second subsystem generating at least a second phase of the pulse waveform, the second subsystem having a second power source, a second energy reservoir, and an adjustment component that adjusts a slope of the second phase of the pulse waveform or an amplitude of the second phase of the pulse waveform;

a control logic unit controlling the first and second subsystems to generate a pulse waveform having the at least one first phase and the at least one second phase; and

wherein the adjustment component in each of the first and second subsystems further comprises an array of capacitors and an array of resistors.

2. The generator of claim 1, wherein the control logic unit further comprises a switching component that switches between the first and second subsystems to generate a pulse waveform having the at least one first phase and the at least one second phase.

3. The generator of claim 1, wherein the generated pulse waveform has a plurality of first phases and a plurality of second phases to generate a multiphasic pulse waveform.

4. The generator of claim 1, wherein the generated pulse waveform has a single first phase and a single second phase to generate a biphasic pulse waveform.

5. The generator of claim 1, wherein the generated pulse waveform has a first phase with a positive polarity and a second phase with a negative polarity.

6. The generator of claim 1, wherein the generated pulse waveform has a first phase with a negative polarity and a second phase with a positive polarity.

7. The generator of claim 1, wherein the generated pulse waveform has an energy of between 0.1 and 200 joules of energy delivered to the patient during the first and second phases and the inter-pulse period between the first and second phases of the generated pulse waveform.

8. The generator of claim 7, wherein energy of the generated pulse waveform is delivered to the patient during a 2ms to 20ms time period.

9. The generator of claim 1, wherein the array of capacitors is one of series connected capacitors, parallel connected capacitors, and series-parallel connected capacitors.

10. The generator of claim 1, further comprising an array of capacitors that adjust a slope of at least one phase of the pulse waveform.

11. The generator of claim 10, wherein the array of capacitors is one of series connected capacitors, parallel connected capacitors, and series-parallel connected capacitors.

12. The generator of claim 1, wherein the adjustment component is an array of resistors, wherein one or more resistors are selected to adjust a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

13. The generator of claim 12, wherein the array of resistors is one of series connected resistors, parallel connected resistors, and series-parallel connected resistors.

14. The generator of claim 1, wherein the control logic unit adjusts timing for at least one phase of the pulse waveform.

15. The generator of claim 14, wherein the control logic unit adjusts the timing for at least one phase of the pulse waveform based on the measurement of the patient.

16. The generator of claim 1, wherein the control logic unit adjusts a timing of an inter-phase period between the first phase and the second phase of the pulse waveform.

17. The generator of claim 16, wherein the control logic unit adjusts the timing for the inter-phase period based on measurements of the patient.

18. A biphasic or multiphasic pulse generator comprising:

a first subsystem to generate at least a first phase and a second phase of a pulse waveform, the first subsystem having an array of power sources and an array of energy reservoirs assignable into first and second groups to separately generate the first and second phases of the pulse waveform using the first and second groups of the first subsystem, respectively;

each of the first and second groups of the first subsystem having an adjustment component that adjusts a slope of a phase of a pulse waveform generated by the first or second group or an amplitude of a phase of a pulse waveform generated by the first or second group;

a control logic unit that controls the distribution of the first and second groups from the first subsystem to generate a pulse waveform having the at least one first phase and the at least one second phase; and

19. The generator of claim 18, wherein the control logic unit further comprises a switching component that switches between the first group and the second group of the first subsystem to generate a pulse waveform having the at least one first phase and the at least one second phase.

20. The generator of claim 18, wherein the generated pulse waveform has a plurality of first phases and a plurality of second phases to generate a multiphasic pulse waveform.

21. The generator of claim 18, wherein the generated pulse waveform has a single first phase and a single second phase to generate a biphasic pulse waveform.

22. The generator of claim 18, wherein the generated pulse waveform has a first phase with a positive polarity and a second phase with a negative polarity.

23. The generator of claim 18, wherein the generated pulse waveform has a first phase with a negative polarity and a second phase with a positive polarity.

24. The generator of claim 18, wherein the generated pulse waveform has an energy of between 0.1 and 200 joules of energy delivered to the patient during the first and second phases and the inter-pulse period between the first and second phases of the generated pulse waveform.

25. The generator of claim 24, wherein energy of the generated pulse waveform is delivered to the patient during a 2ms to 20ms time period.

26. The generator of claim 18, wherein the array of capacitors is one of series connected capacitors, parallel connected capacitors, and series-parallel connected capacitors.

27. The generator of claim 18, further comprising an array of capacitors that adjust a slope of at least one phase of the pulse waveform.

28. The generator of claim 27, wherein the array of capacitors is one of series connected capacitors, parallel connected capacitors, and series-parallel connected capacitors.

29. The generator of claim 18, wherein the adjustment component is an array of resistors, wherein one or more resistors are selected to adjust a slope of at least one phase of the pulse waveform or an amplitude of at least one phase of the pulse waveform.

30. The generator of claim 29, wherein the array of resistors is one of series connected resistors, parallel connected resistors, and series-parallel connected resistors.

31. The generator of claim 18, wherein the control logic unit adjusts timing for at least one phase of the pulse waveform.

32. The generator of claim 31, wherein the control logic unit adjusts the timing for at least one phase of the pulse waveform based on the measurement of the patient.

33. The generator of claim 18, wherein the control logic unit adjusts a timing of an inter-phase period between the first phase and the second phase of the pulse waveform.

34. The generator of claim 33, wherein the control logic unit adjusts the timing for the inter-phase period based on measurements of the patient.