WO2016149620A1 - Nouvelle forme d'onde à impulsion biphasique ou multiphasique et procédé associé - Google Patents

Nouvelle forme d'onde à impulsion biphasique ou multiphasique et procédé associé Download PDF

Info

Publication number
WO2016149620A1
WO2016149620A1 PCT/US2016/023140 US2016023140W WO2016149620A1 WO 2016149620 A1 WO2016149620 A1 WO 2016149620A1 US 2016023140 W US2016023140 W US 2016023140W WO 2016149620 A1 WO2016149620 A1 WO 2016149620A1
Authority
WO
WIPO (PCT)
Prior art keywords
phase
waveform
biphasic
pulse
polarity
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2016/023140
Other languages
English (en)
Inventor
Douglas M. RAYMOND
Peter D. Gray
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiothrive Inc
Original Assignee
Cardiothrive Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/662,137 external-priority patent/US9833630B2/en
Application filed by Cardiothrive Inc filed Critical Cardiothrive Inc
Publication of WO2016149620A1 publication Critical patent/WO2016149620A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/3615—Intensity
    • A61N1/36153—Voltage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3906—Heart defibrillators characterised by the form of the shockwave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3625—External stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3904—External heart defibrillators [EHD]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3906—Heart defibrillators characterised by the form of the shockwave
    • A61N1/3912—Output circuitry therefor, e.g. switches

Definitions

  • the second (or Negative) phase of the Biphasic waveform is currently characterized by a lower amplitude starting point than the first (or Positive) phase of the Biphasic waveform, as shown in Figure 2.
  • This is due to the partial draining of the high-energy reservoir during delivery of the initial Positive phase and then, after inverting the polarity of the waveform so that the Negative phase is able to be delivered, there is only the same partially drained amount of energy remaining in the energy reservoir.
  • This lower amplitude starting point constrains and causes the lower initial amplitude of the Negative phase of the waveform.
  • the typical exponential decay discharge is shown by the Positive phase of the waveform shown in Figure 2.
  • the standard biphasic pulse waveform has been in common usage in manual
  • defibrillators and in AEDs since the mid-1990s, and still results in energy levels of anywhere from 120 to 200 joules or more being delivered to the patient in order to be efficacious.
  • WCDs generally need to deliver shocks of 150-200 joules in order to be efficacious, and this creates a lower limit on the size of the electrical components and the batteries required, and hence impacts the overall size of the device and the comfort levels for the patient wearing it.
  • FIG. 9 illustrates a conventional AED 800, which includes a base unit 802 and two pads 804. Sometimes paddles with handles are used instead of the pads 804. The pads 804 are connected to the base unit 802 using electrical cables 806.
  • Figure 1 illustrates a medical device that may generate and deliver a biphasic or multiphasic waveform
  • Figure 2 illustrates a standard biphasic pulse waveform where the second (negative) phase of the waveform is smaller in amplitude than that of the first (positive) phase of the waveform.
  • Figures 4A and 4B illustrate the shape of a biphasic pulse waveform where the first phase of the waveform is slightly smaller in amplitude than that of the second phase of the waveform.
  • Figure 5 illustrates the shape of a biphasic pulse waveform where the first phase of the waveform is significantly smaller in amplitude than that of the second phase of the waveform.
  • Figure 6 illustrates the shape of a biphasic pulse waveform where the first phase of the waveform is significantly smaller in amplitude than that of the second phase of the waveform, and where the first phase is a negative phase and the second phase is a positive phase.
  • Figure 10 illustrates a biphasic waveform where the first phase of the waveform is significantly smaller in amplitude than the amplitude of the second phase of the waveform and a range of phase tilt variables for each of the phases are shown diagrammatically.
  • the novel biphasic or multiphasic waveform pulse is a distinctly different family of waveforms compared to the standard biphasic waveforms (see Figure 2) which has been used for the past several decades for defibrillators where the second phase's leading edge amplitude is the same as the first phase's trailing edge amplitude.
  • the novel biphasic or multiphasic waveform pulse is also substantially different from the even higher energy dual capacitor biphasic waveform (see Figure 3) that was explored in the 1980s.
  • the novel biphasic or multiphasic waveform pulse allows for an efficacious pulse waveform to be delivered to the patient at a substantially lower level of total energy than ever before.
  • successful defibrillation has been demonstrated using the novel biphasic or multiphasic waveform pulse, repeatedly, and at significantly lower levels of total delivered energy than the energy required by any current external defibrillators using either the original monophasic pulse or the now traditional biphasic pulse.
  • the novel biphasic or multiphasic waveform pulse may deliver 0.1 to 200 joules to a patient.
  • the time for the waveform pulse delivery is between 1-20 ms and preferably 8-10 ms for the combined first and second phases of the waveform, although for triphasic and quadriphasic waveforms this is preferably in the 8-16 ms range for the entire waveform.
  • the waveform period may be on the order of microseconds or shorter.
  • the novel biphasic or multiphasic waveform pulse also significantly reduces both the total energy and the current levels that must be discharged into the patient, thus reducing the chance of either skin burns or other damage to the skin, tissue or organs of the patient.
  • the novel biphasic or multiphasic waveform pulse also reduces the maximum amount of energy that a device is required to store and deliver, and it increases the maximum lifespan of any battery powered device due to a more frugal use of the energy stored within it.
  • the novel biphasic or multiphasic waveform pulse also enables the production of smaller devices as a lower total amount of energy is needed to be stored and delivered to the patient.
  • the first phase (that may be a positive polarity as shown in Figure 4B or a negative polarity) may have a rise time of the leading edge A and an amplitude of the leading edge A, a time of decay slope B and a phase tilt of the decay slope B, a fall time of trailing edge C and an amplitude of the trailing edge C.
  • the second phase (that may be a negative polarity as shown in Figure 4B or a positive polarity, but is an opposite polarity of phase A) may have a rise time of leading edge D, an amplitude of the leading edge D, a time of decay slope E, a phase tilt of the decay slope E, a fall time of trailing edge F and an amplitude of the trailing edge F.
  • the decay slope/tilt, for example, for each phase of the waveform may be between 0% and 95%.
  • Each of the above characteristics of the pulse waveform may be adjusted and optimized depending on the exact therapeutic use to which the waveform is being put, as well as upon the nature and positioning of the device (external or implantable) and also upon the specifics of the patients themselves.
  • a biphasic waveform is shown in Figure 4B, a multiphasic waveform may have multiple phases (each phase with its own duration and amplitude) and multiple inter-phase periods. Each phase of the multiphasic waveform may have independent or the same adjustable rise time, slope time and fall time characteristics.
  • Figures 5 and 6 illustrate additional examples of a biphasic waveform.
  • the example in Figure 5 of the waveform has a first positive polarity phase and a second negative polarity phase.
  • the example in Figure 6 of the waveform has a first negative polarity phase and a second positive polarity phase.
  • the first phase has a polarity and then the second phase has an opposite polarity.
  • Figure 7 illustrates an example of a multiphasic waveform that has a plurality of positive polarity phases (3 in this example) and a plurality of negative polarity phases (3 in this example).
  • the amplitude of the first phase is small than the amplitudes of the subsequent positive phases and the negative phases.
  • the novel biphasic or multiphasic waveform pulse may have different phase tilts for either or both phases as shown in Figure 10.
  • the novel biphasic or multiphasic waveform pulse may be generated and delivered to the patient in a lower energy manner, by only delivering portions of the pulse waveform to the patient. This can be done with the whole waveform (see Figure 11 and Figure 12) or else with individual phases of the waveform according to the energy conservation needs and the therapeutic needs. This can be accomplished via multiple means, including internal and external shunting of the current using high speed switching.
  • a medical device 102 may have a biphasic or multiphasic waveform generator 104 and an energy source 106 that may be coupled to a control logic unit

Landscapes

  • Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne une nouvelle forme d'onde à impulsion biphasique ou multiphasique thérapeutique et un procédé associé. La nouvelle forme d'onde à impulsion biphasique ou multiphasique thérapeutique peut être utilisée dans un défibrillateur ou dans un autre dispositif médical qui délivre des impulsions de stimulation électriques thérapeutiques à un patient.
PCT/US2016/023140 2015-03-18 2016-03-18 Nouvelle forme d'onde à impulsion biphasique ou multiphasique et procédé associé Ceased WO2016149620A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/662,137 2015-03-18
US14/662,137 US9833630B2 (en) 2013-06-14 2015-03-18 Biphasic or multiphasic pulse waveform and method

Publications (1)

Publication Number Publication Date
WO2016149620A1 true WO2016149620A1 (fr) 2016-09-22

Family

ID=56920141

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/023140 Ceased WO2016149620A1 (fr) 2015-03-18 2016-03-18 Nouvelle forme d'onde à impulsion biphasique ou multiphasique et procédé associé

Country Status (1)

Country Link
WO (1) WO2016149620A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120259382A1 (en) * 2011-04-07 2012-10-11 Greatbatch, Ltd. Charge balancing for arbitrary waveform generator & neural stimulation application

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120259382A1 (en) * 2011-04-07 2012-10-11 Greatbatch, Ltd. Charge balancing for arbitrary waveform generator & neural stimulation application

Similar Documents

Publication Publication Date Title
US11083904B2 (en) Bisphasic or multiphasic pulse waveform and method
US6438418B1 (en) Method and apparatus for reduction of pain from electric shock therapies
US9656094B2 (en) Biphasic or multiphasic pulse generator and method
US9907970B2 (en) Therapeutic system and method using biphasic or multiphasic pulse waveform
US3738370A (en) Method of defibrillating a malfunctioning heart by means of electrodes located within the atrium
US10773090B2 (en) Dynamically adjustable multiphasic defibrillator pulse system and method
ES2376516T3 (es) Sistema generador de impulsos.
JP7015693B2 (ja) マルチベクトル患者電極システム及び使用方法
US6002962A (en) Implantable triphasic waveform defibrillator
AU2016232837B2 (en) Novel biphasic or multiphasic pulse generator and method
WO2016149623A1 (fr) Système thérapeutique et procédé associé faisant appel à une forme d'onde à impulsion biphasique ou multiphasique
US20260069875A1 (en) Rotating electric field apparatus and method for eliminating high frequency arrhythmic electrical states of biological organs and tissues
Hopps Cardiac Resuscitation—The Present Status of Defibrillation and Stimulation Techniques
Santos et al. Transdermal atrial defibrillation with bipolar low-tilt pulses
HK1223876B (en) Dynamically adjustable multiphasic defibrillator pulse system

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16765828

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16765828

Country of ref document: EP

Kind code of ref document: A1