Dynamically adjustable multiphasic defibrillator pulse system and method

Information

  • Patent Grant
  • 9855440
  • Patent Number
    9,855,440
  • Date Filed
    Monday, April 10, 2017
    7 years ago
  • Date Issued
    Tuesday, January 2, 2018
    6 years ago
Abstract
A dynamically adjustable multiphasic pulse system and method are provided. The dynamically adjustable multiphasic pulse system may be used as pulse system for a defibrillator or cardioverter. The dynamically adjustable multiphasic pulse system may include a subsystem that generates a first phase of a pulse, a separate subsystem that generates a second phase of the pulse and a switch element that switches between the subsystem and the separate subsystem to generate a therapeutic pulse having at least one positive phase and at least one negative phase.
Description
FIELD

The disclosure relates to medical devices and in particular to devices and methods that generate therapeutic treatment pulses used in medical devices, such as cardioverters and defibrillators.


BACKGROUND

A primary task of the heart is to pump oxygenated, nutrient-rich blood throughout the body. Electrical impulses generated by a portion of the heart regulate the pumping cycle. When the electrical impulses follow a regular and consistent pattern, the heart functions normally and the pumping of blood is optimized. When the electrical impulses of the heart are disrupted (i.e., cardiac arrhythmia), this pattern of electrical impulses becomes chaotic or overly rapid, and a sudden cardiac arrest may take place, which inhibits the circulation of blood. As a result, the brain and other critical organs are deprived of nutrients and oxygen. A person experiencing sudden cardiac arrest may suddenly lose consciousness and die shortly thereafter if left untreated.


The most successful therapy for sudden cardiac arrest is prompt and appropriate defibrillation. A defibrillator uses electrical shocks to restore the proper functioning of the heart. A crucial component of the success or failure of defibrillation, however, is time. Ideally, a victim should be defibrillated immediately upon suffering a sudden cardiac arrest, as the victim's chances of survival dwindle rapidly for every minute without treatment.


There are a wide variety of defibrillators. For example, implantable cardioverter-defibrillators (ICD) involve surgically implanting wire coils and a generator device within a person. ICDs are typically for people at high risk for a cardiac arrhythmia. When a cardiac arrhythmia is detected, a current is automatically passed through the heart of the user with little or no intervention by a third party.


Another, more common type of defibrillator is the automated external defibrillator (AED). Rather than being implanted, the AED is an external device used by a third party to resuscitate a person who has suffered from sudden cardiac arrest. FIG. 10 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.


A typical protocol for using the AED 800 is as follows. Initially, the person who has suffered from sudden cardiac arrest is placed on the floor. Clothing is removed to reveal the person's chest 808. The pads 804 are applied to appropriate locations on the chest 808, as illustrated in FIG. 10. The electrical system within the base unit 802 generates a high voltage between the two pads 804, which delivers an electrical shock to the person. Ideally, the shock restores a normal cardiac rhythm. In some cases, multiple shocks are required.


Another type of defibrillator is a Wearable Cardioverter Defibrillator (WCD). Rather than a device being implanted into a person at-risk from Sudden Cardiac Arrest, or being used by a bystander once a person has already collapsed from experiencing a Sudden Cardiac Arrest, the WCD is an external device worn by an at-risk person which continuously monitors their heart rhythm to identify the occurrence of an arrhythmia, to correctly identify the type of arrhythmia involved and then to automatically apply the therapeutic action required for the type of arrhythmia identified, whether the therapeutic action is cardioversion or defibrillation. These devices are most frequently used for patients who have been identified as potentially requiring an ICD and to effectively protect them during the two to six month medical evaluation period before a final decision is made and they are officially cleared for, or denied, an ICD.


The current varieties of defibrillators available on the market today, whether Implantable Cardioverter Defibrillators (ICDs) or Automatic External Defibrillators (AEDs) or any other variety such as Wearable Cardioverter Defibrillators (WCDs), predominantly utilize either a monophasic waveform or a biphasic waveform for the therapeutic defibrillation high-energy pulse. Each manufacturer of defibrillators, for commercial reasons, has their own unique and slightly different take on waveform design for their devices' pulses. Multiple clinical studies over the last couple of decades have indicated that use of a biphasic waveform has greater therapeutic value than a monophasic waveform does to a patient requiring defibrillation therapy and that biphasic waveforms are efficacious at lower levels of energy delivery than monophasic waveforms.


All of the current products that use a biphasic waveform pulse have a single high-energy reservoir, which, while simple and convenient, results in severe limitation on the range of viable pulse shapes that can be delivered. Specifically, 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 FIG. 3. 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 FIG. 5 and how the reservoir would have continued to discharge (if the polarity had not been switched) is shown as a dashed line in FIG. 5.





BRIEF DESCRIPTION OF THE DRAWINGS


FIGS. 1A and 1B illustrate a multiphasic waveform system with a plurality of independent subsystems each with its own energy reservoir and energy source;



FIG. 2 illustrates another embodiment of the multiphasic waveform system with two independent subsystems each with its own energy reservoir and energy source;



FIG. 3 illustrates a typical H-bridge circuit;



FIG. 4 illustrates an H-bridge circuit in the multiphasic waveform system;



FIG. 5 illustrates a Biphasic pulse waveform where the negative phase of the waveform is smaller in amplitude than that of the positive phase of the waveform;



FIG. 6 illustrates a shape of a Biphasic pulse waveform that may be generated by the systems in FIGS. 1 and 2 where the negative phase of the waveform is identical in amplitude to that of the positive phase of the waveform;



FIG. 7 illustrates a shape of Biphasic pulse waveform that may be generated by the systems in FIGS. 1 and 2 where the negative phase of the waveform is larger in amplitude to that of the positive phase of the waveform;



FIG. 8 illustrates a shape of Multiphasic pulse waveform that may be generated by the systems in FIGS. 1 and 2 where the negative phases of the waveform are interlaced or alternated with those of the positive phases of the waveform, where the amplitudes of each phase steadily decrease;



FIG. 9 illustrates a shape of Multiphasic pulse waveform that may be generated by the systems in FIGS. 1 and 2 where the negative phases of the waveform are interlaced or alternated with those of the positive phases of the waveform, where the amplitudes of each phase remain the same; and



FIG. 10 diagrammatically illustrates an example of a conventional defibrillator.





DETAILED DESCRIPTION OF ONE OR MORE EMBODIMENTS

The disclosure is particularly applicable to a multiphasic pulse system for an external defibrillator and it is in this context that the disclosure will be described. It will be appreciated, however, that the multiphasic pulse system has greater utility since it may be used to generate one or more pulses for other systems. For example, the pulse system may be used to generate therapeutic treatment pulses for other types of defibrillators, cardioverters or other systems. For example, the pulse system may be used to generate therapeutic treatment pulses and then provide the pulses to a patient using paddles or pads. When used for defibrillation, the pulse system may generates the pulses and deliver them to a patient through two defibrillation pads or paddles.


The multiphasic pulse system overcomes the limitation on the amplitude of follow on phases of the pulse waveform by using two or more high-energy reservoirs and/or sources, such as the four shown in FIGS. 1A and 1B. The pulse system 10 is not limited to any particular number of energy reservoirs (such as capacitors) or energy sources (such as batteries). The pulse system 10 may have a plurality or “n” number (as many as wanted) subsystems 12, 14 that together can be utilized to provide the various multiphasic waveforms, examples of which are shown in FIGS. 5-9 and described below. In the example implementation shown in FIG. 1A, 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 a pulse (that may be a positive pulse or a negative pulse.) The two or more subsystems 12, 14 permit the system to shape the various characteristics of a positive phase of the waveform separately from the shaping of the characteristics of the negative phase of the waveform and vice versa. The above described functions may be accomplished through the use of a fast switching high-energy/voltage switch system as described below.


Each subsystem 12, 14 of each side, as shown in FIG. 1B, may have a control logic and heart rhythm sense component 20 (that is connected to a similar component on the other side by a digital control link 30 as shown in FIG. 1A) that may be also coupled to a high voltage switching system component 22. The high voltage switching system component 22 may be implemented using either analog circuits or digital circuits or even some hybrid of the two approaches. Furthermore, the high voltage switching system component 22 may be implemented through the use of mechanical or solid-state switches or a combination of the two. As shown in FIG. 4, the high voltage switching system component 22 may be implemented using one or more semiconductor circuits, such as the insulated gate bipolar transistors. The high voltage switching system component 22 may be coupled to an energy reservoir 24 and the energy reservoir 24 may be coupled to a power source 26, such as a battery. The energy reservoir 24 may further comprise a reservoir 24A, such as for example one or more capacitors or a capacitor array, and a high voltage generator 24B. The energy reservoir 24 may also be coupled, by a high voltage return line 32 to the other side of the system as shown in FIG. 1A. The high voltage return 32 electrically completes the circuit and is present in existing defibrillators, but in a slightly different form since in the existing style of devices it is split into two parts: in the form of the two leads which go from the main defibrillator device to the internal or external surface of the patient.


The control logic and heart rhythm sense component 20 is well known in the art and the component analyzes the ECG signals from the patient for treatable arrhythmias and then chooses to shock the patient when a treatable arrhythmia is detected, along with guiding the operator through both visual and audible means through this process when the device is of the external automated variety. The control logic and heart rhythm sense component 20 also may control and shape the therapeutic pulse as it is delivered from the energy reservoir and ensures that it is as optimal as possible for the individual patient. In the implementations shown in FIGS. 1A and 2, the control logic and heart rhythm sense component 20 may generate the therapeutic pulse using the one or more groups of subsystems since each subsystem may have its own control logic 20 (so that each of them can control just the portion/phase of the pulse/waveform that they deliver. This provides a much higher level of control over what range of waveform shapes can be used/delivered, including many that are not possible with the existing devices. This also provides better weight and size distribution, as well as size and weight reductions, and the ability to have the devices look radically different and be handled in very different ways—ones that are much more operator intuitive. The disclosed system also provides a much higher level of redundancy and fault mitigation for the device embodiments that use it.


In one implementation, each control logic in each subsystem may have a circuit that can be used to adjust the shape of each portion of the therapeutic pulse. The circuit, may be for example, an array of resistors of various strengths and switches so that one or more of the resistor may be selected (as an array of selectable resistors) that can optimize and alter an RC constant of a subsystem's pulse phase generating circuitry in order to dynamically shape one or more pulse phases.


In some embodiments of the system, the system may provide for the recharging of individual energy reservoirs by the energy sources during times (including inter-pulse times) that an individual energy reservoir is not selected for discharge as shown in FIGS. 1A and 2. This provides the opportunity to interlace equivalent amplitude initial multiphasic pulses utilizing several different high energy reservoirs as shown in FIG. 9.


In one implementation, the system 10 may consist of two or more high-energy therapeutic pulse delivery sub-systems 12, 14 as shown in FIG. 2, such as Side A and Side B. In the implementation shown in FIG. 2, the side A may deliver one or more of a Positive phase waveform of the Multiphasic therapeutic pulse and Side B may deliver one or more of a Negative phase waveform of the Multiphasic therapeutic pulse. The subsystem in each side of the system in FIG. 2 may have the same elements as shown in FIG. 1B and described above. As shown in FIGS. 1A and 2, the subsystems may be coupled to the patient 16 by one or more high voltage leads and one or more sense leads wherein the high voltage leads deliver the therapeutic pulse and the sense leads are used to detect the heartbeat by the control unit.


The system 10 may either be pre-programmed to use a specific single multiphasic pulse shape, according to which one is shown to be most efficacious in clinical lab testing/trials, or else it may select the best one for a given purpose from a lookup table where they are listed according to their suitability for optimally resolving different types of arrhythmia that are being screened for and identified or for the different treatments as described above. Regardless, the system and method allows the use and application of a much wider range of pulse shapes than has been previously possible and this will allow the devices which use this invention to keep up with clinical developments as waveforms continue to be improved.



FIG. 3 illustrates a typical H-bridge circuit 300 and FIG. 4 illustrates an H-bridge circuit concept used in the multiphasic waveform system. As shown in FIG. 3, an H-bridge circuit is a known electronic circuit that enables a voltage, such as Vin, to be applied across a load, M, in either direction using one or more switches (S1-S4) (see http://cp.literature.agilent.com/litweb/pdf/5989-6288EN.pdf that is incorporated by reference herein for additional details about the H-bridge circuit.) As shown in FIG. 3, the H-bridge circuit may have a first portion 302 and a second portion 304 that form the complete H-bridge circuit.


As shown in FIG. 4, the H-bridge circuit may be part of the control circuits or switching systems shown in FIGS. 1-2. The load of the H-bridge circuit in the multiphasic system is the patient 16 to which the therapeutic pulse is going to be applied to provide treatment to the patient. The treatment to the patient, depending on the power and/or energy level of the therapeutic pulse may be for cardiac pacing, cardioversion, defibrillation, neurological therapy, nerve therapy or musculoskeletal therapy. Each side of the multiphasic system may generate its energy as described above and an H-bridge circuit 400 may be used to apply two (or more) unique energy sources to the single load. In the example shown in FIG. 4, each side of the system (such as side A and side B shown in FIGS. 1A and 2) may have a portion 402, 404 of the H-bridge so that the multiphasic system has a complete H-bridge circuit that is combination of portions 402, 404. The multiphasic system may then be used to deliver the therapeutic pulse through defibrillation paddles, such as Paddle A and Paddle B as shown in FIG. 4) to the patient.


Each portion 402, 404 of the H-bridge has its own energy source, 1600 VDC in the example in FIG. 4. In each portion of the H-bridge, the energy source may be switched using switches 406, 408 to make contact with the patient at a separate but specific time. The switches for each portion may be part of the switching system shown in FIGS. 1-2. In the example in FIG. 4, each portion may have two switches and each switch may be a commercially available insulated-gate bipolar transistor (IGBT.) Each switch may be controlled by a separate trigger signal as shown to discharge the energy to the patient. This provides for the two or more energy sources to discharge their energy to the load (patient) at a precise time, generating a resulting Biphasic discharge pulse or other therapeutic pulse shapes (examples of which are shown in FIGS. 5-9) as defined for an application, or therapeutic condition.


In the system, a therapeutic pulse may comprise one or more positive pulses and one or more negative pulses. As shown in FIGS. 1A and 2, each side (A & B) has one or more independent high-energy subsystems 12, 14 so that the magnitude and the timing for each of the Positive & Negative phases of the Multiphasic therapeutic pulse are independent and can therefore be independently controlled so as to provide a variety of different pulses as shown in FIGS. 5-9. FIG. 5 is typical of the current Biphasic therapeutic pulses available in many defibrillators currently on the market today (with a positive pulse and negative pulse as shown) that may also be generated by the systems in FIGS. 1A and 2. FIG. 6 illustrates a therapeutic pulse generated by the pulse system in which the magnitude of the Positive and Negative phases of the waveform are equal in starting amplitude. Furthermore, because each side or portion of the waveform generating circuit (subsystems A & B) are independent, the amplitude of the Positive phase of the waveform can be smaller in magnitude than the Negative phase of the waveform, as illustrated in FIG. 7. Additionally, due to the independent nature of the two (or more) subsystems in the circuit, it is possible to alternate the Positive and Negative phases at intervals throughout the delivery of the Multiphasic therapeutic pulse as shown in FIGS. 8 and 9, or that the second (or later) phase of the pulse can be of a measurably lower amplitude than would normally be deliverable from a single partially depleted energy reservoir. Further, each of the subsystems may have a dynamically variable and selectable voltage output such that the amplitude of each pulse phase can be individually controlled. In one implementation of the system, the therapeutic pulses in FIGS. 4-9 may be therapeutic defibrillation or cardioversion pulses. In another implementation of the system, the therapeutic pulses in FIGS. 5-9 may be lower energy therapeutic pulses used in the treatment of neurological, nerve or musculoskeletal conditions. Thus, the pulse generation system may generate pulse phases at any of a variety of power and energy levels allowing for the use of the pulses for a variety of purposes such as in cardiac pacing, cardioversion and defibrillation in addition to neurological, nerve or musculoskeletal therapies.


While the foregoing has been with reference to a particular embodiment of the invention, 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 multiphasic pulse generator, comprising: a subsystem that generates a first phase of a pulse, the subsystem having a power source and an energy reservoir, wherein the first phase has a shape and is one of a positive phase of the pulse and a negative phase of the pulse;a separate subsystem that generates a second phase of the pulse, the separate subsystem having a second power source and a second energy reservoir, wherein the second phase is shaped independently from the shape of the first phase and is an opposite polarity phase to the first phase; anda switch element that switches between the subsystem and the separate subsystem to generate a therapeutic pulse having at least one positive phase and at least one negative phase.
  • 2. The generator of claim 1, wherein each of the subsystem and the separate subsystem further comprises a circuit that adjusts a shape of the first phase of the pulse and the second phase of the pulse, respectively.
  • 3. The generator of claim 2, wherein the circuit includes an array of selectable resistors.
  • 4. The generator of claim 2, wherein the circuit includes an array of selectable capacitors.
  • 5. The generator of claim 1, wherein the switch element further comprises a high voltage switch element.
  • 6. The generator of claim 5, wherein the high voltage switch element further comprises one or more semiconductor circuits.
  • 7. The generator of claim 6, wherein the one or more semiconductor circuits further comprises one or more insulated gate bipolar transistors.
  • 8. The generator of claim 1, wherein each of the subsystem and the separate subsystem further comprises control logic to control, respectively, the first and second phase of the pulse.
  • 9. The generator of claim 8, wherein each of the control logic further comprises a lookup table to select the pulse shape.
  • 10. A method for generating a therapeutic pulse, comprising: generating one or more positive phases for a pulse using a power source and an energy reservoir;generating one or more negative phases for a pulse using a second power source and a second energy reservoir; andswitching between the one or more positive phases and the one or more negative phases to generate a therapeutic pulse having at least one positive phase and at least one negative phase.
  • 11. The method of claim 10, further comprising adjusting a shape of each of the one or more negative phases and independently adjusting a shape of each of the one or more positive phases.
  • 12. The method of claim 10, further comprising individually selecting an amplitude of one or more of the one or more positive phases and one or more negative phases of the pulse.
  • 13. The method of claim 10, further comprising recharging the energy reservoir when the energy reservoir is not being discharged.
  • 14. The method of claim 10, further comprising recharging the second energy reservoir when the second energy reservoir is not being discharged.
  • 15. The method of claim 10, further comprising alternating between the one or more positive phases and the one or more negative phases when generating the therapeutic pulse.
  • 16. The method of claim 10, wherein generating the therapeutic pulse further comprises selecting a shape of the therapeutic pulse using a lookup table.
PRIORITY CLAIMS/RELATED APPLICATIONS

This application claims priority to under 35 USC 120 and a continuation of U.S. patent application Ser. No. 14/303,541, filed Jun. 12, 2014 and titled “Dynamically Adjustable Multiphasic Defibrillator Pulse System And Method” (issued as U.S. Pat. No. 9,616,243) which in turn claims priority under 35 USC 120 and claims the benefit under 35 USC 119(e) to U.S. Provisional Patent Application Ser. No. 61/835,443 filed Jun. 14, 2013 and titled “Dynamically Adjustable Multiphasic Defibrillator Pulse System and Method”, the entirety of all of which are incorporated herein by reference.

US Referenced Citations (136)
Number Name Date Kind
4441498 Nordling Apr 1984 A
5199429 Kroll et al. Apr 1993 A
5240995 Gyory Aug 1993 A
5290585 Elton Mar 1994 A
5338490 Dietz Aug 1994 A
5362420 Itoh Nov 1994 A
5402884 Gilman et al. Apr 1995 A
5489624 Kantner Feb 1996 A
5536768 Kantner Jul 1996 A
5573668 Grosh Nov 1996 A
5643252 Waner et al. Jul 1997 A
5658316 Lamond et al. Aug 1997 A
5660178 Kantner Aug 1997 A
5733310 Lopin et al. Mar 1998 A
5800685 Perrault Sep 1998 A
5871505 Adams Feb 1999 A
5987354 Cooper Nov 1999 A
6004312 Finneran et al. Dec 1999 A
6006131 Cooper et al. Dec 1999 A
6056738 Marchitto et al. May 2000 A
6141584 Rockwell et al. Oct 2000 A
6197324 Crittenden Mar 2001 B1
6251100 Flock et al. Jun 2001 B1
6256533 Yuzhakov et al. Jul 2001 B1
6266563 Kenknight et al. Jul 2001 B1
6315722 Yaegashi Nov 2001 B1
6329488 Terry Dec 2001 B1
6379324 Gartstein et al. Apr 2002 B1
6477413 Sullivan Nov 2002 B1
6576712 Feldstein Jun 2003 B2
6596401 Terry Jul 2003 B1
6597948 Rockwell et al. Jul 2003 B1
6611707 Prausnitz Aug 2003 B1
6690959 Thompson Feb 2004 B2
6714817 Daynes et al. Mar 2004 B2
6797276 Glenn Sep 2004 B1
6803420 Cleary Oct 2004 B2
6908453 Fleming Jun 2005 B2
6908681 Terry Jun 2005 B2
6931277 Yuzhakov Aug 2005 B1
7072712 Kroll et al. Jul 2006 B2
7108681 Gartstein Sep 2006 B2
7215991 Besson et al. May 2007 B2
7226439 Pransnitz Jun 2007 B2
7463917 Martinez Dec 2008 B2
7645263 Angel et al. Jan 2010 B2
7797044 Covey et al. Sep 2010 B2
8024037 Kumar et al. Sep 2011 B2
8527044 Edwards et al. Sep 2013 B2
8558499 Ozaki et al. Oct 2013 B2
8615295 Savage et al. Dec 2013 B2
8781576 Savage et al. Jul 2014 B2
9089718 Owen et al. Jul 2015 B2
9101778 Savage et al. Aug 2015 B2
9616243 Raymond Apr 2017 B2
9656094 Raymond May 2017 B2
20010031992 Fishler et al. Oct 2001 A1
20010051819 Fishler et al. Dec 2001 A1
20020016562 Cormier et al. Feb 2002 A1
20020045907 Sherman et al. Apr 2002 A1
20020082644 Picardo et al. Jun 2002 A1
20030017743 Picardo et al. Jan 2003 A1
20030055460 Owen et al. Mar 2003 A1
20030088279 Rissmann et al. May 2003 A1
20030125771 Garrett Jul 2003 A1
20030167075 Fincke Sep 2003 A1
20030197487 Tamura et al. Oct 2003 A1
20040105834 Singh Jun 2004 A1
20040143297 Ramsey, III Jul 2004 A1
20040166147 Lundy Aug 2004 A1
20040247655 Asmus Dec 2004 A1
20050055460 Johnson et al. Mar 2005 A1
20050107713 Van Herk May 2005 A1
20050123565 Subramony Jun 2005 A1
20060136000 Bowers Jun 2006 A1
20060142806 Katzman et al. Jun 2006 A1
20060173493 Armstrong et al. Aug 2006 A1
20060206152 Covey et al. Sep 2006 A1
20070016268 Carter et al. Jan 2007 A1
20070078376 Smith Apr 2007 A1
20070135729 Ollmar et al. Jun 2007 A1
20070143297 Recio et al. Jun 2007 A1
20070150008 Jones et al. Jun 2007 A1
20070191901 Schecter Aug 2007 A1
20080082153 Gadsby et al. Apr 2008 A1
20080097546 Powers et al. Apr 2008 A1
20080154110 Burnes et al. Jun 2008 A1
20080154178 Carter et al. Jun 2008 A1
20080177342 Snyder Jul 2008 A1
20080312579 Chang et al. Dec 2008 A1
20080312709 Volpe et al. Dec 2008 A1
20090005827 Weintraub et al. Jan 2009 A1
20090076366 Palti Mar 2009 A1
20090210022 Powers Aug 2009 A1
20090318988 Powers Dec 2009 A1
20090326400 Huldt Dec 2009 A1
20100063559 McIntyre et al. Mar 2010 A1
20100160712 Burnett et al. Jun 2010 A1
20100181629 Hoefler et al. Jul 2010 A1
20100191141 Aberg Jul 2010 A1
20100241181 Savage et al. Sep 2010 A1
20100249860 Shuros et al. Sep 2010 A1
20110028859 Chian Feb 2011 A1
20110071611 Khuon et al. Mar 2011 A1
20110208029 Joucla et al. Aug 2011 A1
20110237922 Parker, III et al. Sep 2011 A1
20110288604 Kaib et al. Nov 2011 A1
20110301683 Axelgaard Dec 2011 A1
20120101396 Solosko et al. Apr 2012 A1
20120112903 Kalb et al. May 2012 A1
20120136233 Yamashita May 2012 A1
20120158075 Kaib et al. Jun 2012 A1
20120158078 Moulder et al. Jun 2012 A1
20120203297 Efimov et al. Aug 2012 A1
20120259382 Trier Oct 2012 A1
20130018251 Caprio et al. Jan 2013 A1
20130144365 Kipke et al. Jun 2013 A1
20140005736 Geheb Jan 2014 A1
20140039593 Savage et al. Feb 2014 A1
20140039594 Savage et al. Feb 2014 A1
20140221766 Kinast Aug 2014 A1
20140276183 Badower Sep 2014 A1
20140277226 Poore et al. Sep 2014 A1
20140317914 Shaker Oct 2014 A1
20140371566 Raymond et al. Dec 2014 A1
20140371567 Raymond et al. Dec 2014 A1
20140371805 Raymond et al. Dec 2014 A1
20140371806 Raymond et al. Dec 2014 A1
20150297104 Chen et al. Oct 2015 A1
20150327781 Hernandez-Silveira Nov 2015 A1
20160206893 Raymond et al. Jul 2016 A1
20160213933 Raymond et al. Jul 2016 A1
20160213938 Raymond et al. Jul 2016 A1
20160296177 Gray et al. Oct 2016 A1
20160361533 Savage et al. Dec 2016 A1
20160361555 Savage et al. Dec 2016 A1
Foreign Referenced Citations (15)
Number Date Country
10 2006 02586 Dec 2007 DE
1 530 983 May 2005 EP
1 834 622 Sep 2007 EP
2000-093526 Jan 1917 JP
2011-512227 Sep 1917 JP
2005-144164 Jun 2005 JP
2007-530124 Nov 2007 JP
2008-302254 Dec 2008 JP
2010-511438 Apr 2010 JP
2010-529897 Sep 2010 JP
2012-135457 Jul 2012 JP
2012-529954 Nov 2012 JP
WO 03020362 Mar 2003 WO
WO 2010146492 Dec 2010 WO
WO2010151875 Dec 2010 WO
Non-Patent Literature Citations (35)
Entry
Claims of U.S. Appl. No. 14/661,949, filed Dec. 15, 2016 (now U.S. Pat. No. 9,656,094).
Yamanouchi, Yoshio, et al. “Optimal Small-Capacitor Biphasic Waveform for External Defibrillation: Influence of Phase-1 Tilt and Phase-2 Voltage.” Jul. 30, 1998. Journal of the American Heart Association, vol. 98. pp. 2487-2493.
CN 201080021650.4, First Office Action dated Jul. 24, 2013 (English and Chinese) (19 pgs.).
CN 201080021650.4, Second Office Action dated Jan. 16, 2014 (English and Chinese) (16 pgs.).
CN 201080021650.4, Third Office Action dated Jun. 17, 2014 (English and Chinese) (18 pgs.).
JP 2012-500855, Notification of Reason for Rejection dated Feb. 17, 2014 (English and Japanese) (3 pgs.).
JP 2014-545921, Notification of Reason for Rejection dated Jun. 1, 2015 (English and Japanese) (7 pgs.).
EP 2408521—Extended European Search Report dated Jul. 10, 2012 (8 pgs.).
PCT/EP2007/009879—PCT International Preliminary Report on Patentability dated May 19, 2009 (7 pgs.).
PCT/EP2007/009879—PCT International Search Report dated Apr. 29, 2008 (3 pgs.).
PCT/EP2007/009879—PCT International Written Opinion dated Apr. 29, 2008 (6 pgs.).
PCT/US2010/027346—PCT International Preliminary Report on Patentability, dated Sep. 20, 2011 (12 pgs.).
PCT/US2010/027346—PCT International Search Report dated Oct. 14, 2010 (4 pgs.).
PCT/US2010/027346—PCT Written Opinion of the International Searching Authority dated Oct. 14, 2010 (7 pgs.).
PCT/US2012/065712—PCT International Search Report dated Mar. 29, 2013 (2 pgs.).
PCT/US2012/065712—PCT Written Opinion dated Mar. 29, 2013 (5 pgs.).
PCT/US2012/65712—PCT International Preliminary Report on Patentability dated Jun. 10, 2014 (6 pgs.).
PCT/US2014/42355—PCT International Search Report dated Nov. 3, 2010 (2 pgs.).
PCT/US2014/42355—PCT Written Opinion dated Nov. 3, 2014 (6 pgs.).
PCT/US2014/42356—PCT International Search Report dated Nov. 3, 2010 (2 pgs.).
PCT/US2014/42356—PCT Written Opinion dated Nov. 3, 2014 (6 pgs.).
PCT/US2014/42360—PCT International Search Report dated Nov. 4, 2010 (2 pgs.).
PCT/US2014/42360—PCT Written Opinion dated Nov. 4, 2014 (4 pgs.).
PCT/US2014/42409—PCT International Search Report dated Nov. 4, 2010 (2 pgs.).
PCT/US2014/42409—PCT Written Opinion dated Nov. 4, 2014 (4 pgs.).
Changes in the passive electrical properties of human stratum corneum due electroporation, dated Dec. 7, 1994. By U. Pliquett, R. Langer, and J. C. Weaver (11 pgs.).
Electrical properties of the epidermal stratum corneum, dated Aug. 12, 1974. By T. Yamamoto and Y. Yamamoto (8 pgs.).
Insertion of microneedles into skin: measurement and prediction of insertion force and needle facture force, dated Dec. 10, 2003. By S. P. Davis, B. J. Landis, Z. H. Adams, M. G. Allen, and M. R. Prausnitz (9 pgs.).
Lack of Pain Associated with Microfabricated Microneedles, dated Oct. 10, 2000. By S. Kaushik, A. H. Hord, D. D. Denson, D. V. McAlliser, S. Smitra, M. G. Allen, and M. R. Prausnitz (3 pgs.).
Microneedle Insertion Force Reduction Using Vibratory Actuation, dated 2004. By M. Yang and J. D. Zahn (6 pgs.).
Non-invasive bioimpedance of intact skin: mathematical modeling and experiments, dated May 2, 2010. By U. Birgersson, E. Birgersson, P. Aberg, I. Nicander, and S. Ollmar (19 pgs.).
Optimal Small-Capacitor Biphasic Waveform for External Defibrillation; Influence of Phase-1 Tilt and Phase-2 Voltage, By Yoshio Yamanouchi, et al. , Journal of the American Heart Association, Dec. 1, 1998, vol. 98, pp. 2487-2493 (8 pgs.).
Polymer Microneedles for Controlled-Release Drug Delivery, dated Dec. 2, 2005. By J-H. Park, M. G. Allen, and M. R. Prausnitz (12 pgs.).
Two Dimensional Metallic Microelectrode Arrays for Extracellular Stimulation and Recording of Neurons, dated 1993. By A. B. Frazier, D. P. O'Brien, and M. G. Allen (6 pgs.).
Utilizing Characteristic Electrical Properties of the Epidermal Skin Layers to Detect Fake Fingers in Biometric Fingerprint Systems-A Pilot Study, dated Dec. 1, 2004. By O. G. Martinsen, S. Clausen, J. B. Nysaether, and S. Grimnes (4 pgs.).
Related Publications (1)
Number Date Country
20170216612 A1 Aug 2017 US
Provisional Applications (1)
Number Date Country
61835443 Jun 2013 US
Continuations (1)
Number Date Country
Parent 14303541 Jun 2014 US
Child 15484055 US