SYSTEM AND METHOD FOR UNIPHASIC AND BIPHASIC SHOCK INVERSION TIME DOMAIN SHIFTING FOR SHOCK ENERGY VECTORING IN TRANSVENOUS AND SUBCUTANEOUS DEFIBRILLATORS WITH TWO OR MORE SHOCK VECTORS
20190381329 ยท 2019-12-19
Inventors
Cpc classification
A61N1/3956
HUMAN NECESSITIES
A61N1/3918
HUMAN NECESSITIES
International classification
Abstract
Method for truncating and summating shock vector energy between at least two shock vectors in a defibrillator, including the procedures of applying at least two biphasic defibrillating shock vectors simultaneously via at least two electrode sets until a voltage inversion point, terminating at least a first one of the biphasic defibrillating shock vectors at the voltage inversion point, and directing a remaining energy of the first one of the biphasic defibrillating shock vectors to a second phase of at least a second one of the biphasic defibrillating shock vectors.
Claims
1. Method for truncating and summating shock vector energy between at least two shock vectors in a defibrillator, comprising the procedures of: applying at least two biphasic defibrillating shock vectors simultaneously via at least two electrode sets until a voltage inversion point; terminating at least a first one of said at least two biphasic defibrillating shock vectors at said voltage inversion point; and directing a remaining energy of said at least first one of said biphasic defibrillating shock vectors to a second phase of at least a second one of said biphasic defibrillating shock vectors.
2. The method according to claim 1, further comprising the procedure of modifying said voltage inversion point of said at least two biphasic defibrillating shock vectors.
3. The method according to claim 2, wherein said procedure of modifying comprises the sub-procedure of modifying said voltage inversion point according to at least one of patient characteristics and defibrillator characteristics.
4. The method according to claim 3, wherein said patient characteristics comprises an anatomy of a patient.
5. The method according to claim 3, wherein said defibrillator characteristics comprises an actual placement of a plurality of electrodes of said defibrillator in a patient.
6. The method according to claim 2, wherein said procedure of modifying comprises the sub-procedure of modifying said voltage inversion point to achieve energy symmetry between said at least two biphasic defibrillating shock vectors.
7. The method according to claim 1, wherein said at least first one of said at least two biphasic defibrillating shock vectors which is terminated at said voltage inversion point exhibits lower impedance compared to said at least second one of said at least two biphasic defibrillating shock vectors.
8. The method according to claim 1, wherein said defibrillator is selected from the list consisting of: an external defibrillator; an intravenous defibrillator; a transvenous defibrillator; and a subcutaneous defibrillator.
9. The method according to claim 1, wherein a defibrillating threshold for effective defibrillation of said defibrillator is as low as possible.
10. Subcutaneous defibrillator for truncating and summating at least two biphasic defibrillating shock vectors, comprising: a body; a plurality of electrodes, positioned on said body, for applying said at least two biphasic defibrillating shock vectors; and a plurality of sensors, positioned on said body, for detecting arrhythmias, said body comprising: at least one capacitor, for storing charge for providing said at least two biphasic defibrillating shock vectors; a processor, coupled with said at least one capacitor; and at least one battery, coupled with said at least one capacitor and said processor, for charging said at least one capacitor and for providing energy to operate said processor, wherein said plurality of electrodes applies at least a first one of said at least two biphasic defibrillating shock vectors and at least a second one of said at least two biphasic defibrillating shock vectors simultaneously until a voltage inversion point; wherein said processor terminates said at least first one of said at least two biphasic defibrillating shock vectors at said voltage inversion point; and wherein said processor directs a remaining energy of said at least first one of said at least two biphasic defibrillating shock vectors to a second phase of said at least second one of said at least two biphasic defibrillating shock vectors.
11. The subcutaneous defibrillator according to claim 10, further comprising a wireless transceiver, coupled with said processor, for programming said processor wirelessly.
12. The subcutaneous defibrillator according to claim 11, wherein said wireless transceiver is selected from the list consisting of: a Bluetooth transceiver; and an infrared transceiver.
13. The subcutaneous defibrillator according to claim 11, wherein said processor can toggle said truncating and summating of said at least two biphasic defibrillating shock vectors on and off via said wireless transceiver.
14. The subcutaneous defibrillator according to claim 13, wherein said subcutaneous defibrillator applies said at least two biphasic defibrillating shock vectors as at least two biphasic defibrillating shock vectors when said processor toggles said truncating and summating off.
15. The subcutaneous defibrillator according to claim 13, wherein said subcutaneous defibrillator applies said at least two biphasic defibrillating shock vectors as at least one truncated uniphasic defibrillating shock vector and at least one summated biphasic defibrillating shock vector when said processor toggles said truncating and summating on.
16. The subcutaneous defibrillator according to claim 11, wherein said processor can modify said voltage inversion point via said wireless transceiver.
17. The subcutaneous defibrillator according to claim 10, wherein said plurality of electrodes comprises at least three electrodes, wherein at least one of said at least three electrodes is disconnected at a given time during the application of said at least two biphasic defibrillating shock vectors.
18. The subcutaneous defibrillator according to claim 10, wherein said at least first one of said at least two biphasic defibrillating shock vectors has a lower impedance compared to said at least second one of said at least two biphasic defibrillating shock vectors having a higher impedance.
19. The subcutaneous defibrillator according to claim 18, wherein said processor truncates said at least first one of said at least two biphasic defibrillating shock vectors having said lower impedance at said voltage inversion point
20. The subcutaneous defibrillator according to claim 18, wherein said processor electronically switches said remaining energy from a first set of said plurality of electrodes applying said at least first one of said at least two biphasic defibrillating shock vectors having said lower impedance to a second set of said plurality of electrodes applying said at least second one of said at least two biphasic defibrillating shock vectors having said higher impedance.
21. Defibrillator for truncating and summating at least two biphasic defibrillating shock vectors, comprising: a can; and a plurality of leads, coupled with said can, for detecting arrhythmias; said can comprising: at least one capacitor, for storing charge for providing said at least two biphasic defibrillating shock vectors; a processor, coupled with said at least one capacitor; and at least one battery, coupled with said at least one capacitor and said processor, for charging said at least one capacitor and for providing energy to operate said processor, wherein said plurality of leads applies at least a first one of said at least two biphasic defibrillating shock vectors and at least a second one of said at least two biphasic defibrillating shock vectors simultaneously until a voltage inversion point; wherein said processor terminates said at least first one of said at least two biphasic defibrillating shock vectors at said voltage inversion point; and wherein said processor directs a remaining energy of said at least first one of said at least two biphasic defibrillating shock vectors to a second phase of said at least second one of said at least two biphasic defibrillating shock vectors.
22. The defibrillator according to claim 21, wherein said defibrillator is selected from the list consisting of: an external defibrillator; an intravenous defibrillator; and a transvenous defibrillator.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0033] The disclosed technique overcomes the disadvantages of the prior art by providing a novel method and system for optimizing the energy delivered in defibrillators with two or more shock vectors. By optimizing the energy provided to each shock vector, problems relating to energy shunting in multi-vectorial defibrillation pulses can be minimized and lower DFTs can be achieved in external, transvenous and subcutaneous defibrillators. According to the disclosed technique, in defibrillators employing two or more biphasic shock vectors, the shock vector with the lower impedance is truncated at its inversion point such that it is made into a unipolar shock vector having only one phase (similar to a uniphasic shock vector) and terminated at its inversion point. The energy of the second phase of the shock vector with lower impedance is transferred and added to the shock vector with higher impedance. Thus, the remaining energy of the second phase of the shock vector with lower impedance is electronically switched from one set of electrodes and directed to another set of electrodes which deliver the shock vector of higher impedance. The biphasic shock vector of higher impedance now includes additional current and voltage from the other biphasic shock vector (now uniphasic) and thus provides an increase in deliverable energy via the shock vector with higher impedance. According to the disclosed technique, some of the energy being provided to an area of lower impedance in and around the heart is therefore shifted to an area of higher impedance in and around the heart, thus achieving an increase in symmetry in the total energy delivered to the heart by shock vectors having difference impedances.
[0034] Also according to the disclosed technique, further symmetry between the shock vectors can be achieved by moving the inversion point of the shock vector with lower impedance. In this manner, substantially full symmetry and balance of energy delivery between the shock vectors can be achieved. By moving the inversion point sooner in time, more energy can be transferred to the shock vector with higher impedance, whereas extending the inversion point in time will provide less energy transfer to the shock vector with higher impedance. According to the disclosed technique, a physician or clinician can optimize the delivery of energy to the two or more shock vectors of a defibrillator of a patient such that the DFT of the particular patient for achieving effective defibrillation is as low as possible. Lower overall DFTs (which by definition provide effective defibrillation) are better for patient comfort and can increase the battery life of an implanted defibrillator, whether implanted transvenously or subcutaneously. As compared with the prior art, the disclosed technique enables the energy delivery in defibrillators to be dynamically shifted and optimized between two or more shock vectors.
[0035] Reference is now made to
[0036] Reference is now made to
[0037] An example of two shock vectors being provided to heart 182 is shown in
[0038] The imbalance in energy delivery between the two shock vectors in
[0039] A second graph 222B shows a waveform energy curve 236 of a second biphasic shock vector. Second graph 222B includes an x-axis 224B showing time in microseconds and a y-axis 226B showing voltage in volts. As shown, the second biphasic shock vector includes two phases, a first phase 238A wherein the waveform energy is applied using a positive voltage and a second phase 238B wherein the waveform energy is applied using a negative voltage. Like in waveform energy curve 228, an inversion point in time for waveform energy curve 236, shown via an arrow 233, is where the voltage of the applied waveform energy changes from positive to negative. As mentioned above, the area under waveform energy curve 236 represents the amount of energy delivered by the second biphasic shock vector. An area 240A in first phase 238A shows the energy delivered by the first phase of the biphasic shock vector whereas an area 240B in second phase 238B shows the energy delivered by the second phase of the biphasic shock vector.
[0040] First and second biphasic shock vectors, with their waveform energy curves as shown in graphs 222A and 222B, are applied simultaneously. According to the disclosed technique, the waveform of the first biphasic shock vector, as shown in graph 222A, is terminated at the inversion point shown by line 232 such that waveform energy curve 228 is effectively only a unipolar shock vector. The energy of second phase 230B, represented by area 234B and shown by the letter A is directed, shown by an arrow 242, to the second biphasic shock vector, as shown in graph 222B as an addition area 240C to second phase 238B. Since both the first and second biphasic shock vectors are applied simultaneously, terminating the first biphasic shock vector at the end of its first phase and directing the remaining energy to the second biphasic shock vector effectively increases the amount of energy delivered by the second biphasic shock vector. The first biphasic shock vector is thus converted into a uniphasic shock vector whereas the second biphasic shock vector remains biphasic with an increase in energy in its second phase.
[0041] Referring back to the example shown in
[0042] Reference is now made to
[0043] Graph 262A shows a waveform energy curve 272A truncated at an early inversion point 270A. An area 274A represents the energy of the first phase of waveform energy curve 272A whereas an area 276A represents the energy of the second phase of waveform energy curve 272A. Area 274A is designated with the letters A and B showing that the energy in area 274A is delivered by both a first shock vector (zone A) and a second shock vector (zone B). In accordance with the disclosed technique, the first shock vector is terminated and truncated at inversion point 270A and the remaining energy of the first shock vector, area 276A, is added, or summated, to the energy of the second shock vector. Area 276A is thus shown as zone B to indicate that this energy from the first shock vector is added to the energy of the second shock vector.
[0044] Graph 2626 shows a waveform energy curve 2726 truncated at a later inversion point 2706 as compared with inversion point 270A. An area 2746 represents the energy of the first phase of waveform energy curve 2726 whereas an area 2766 represents the energy of the second phase of waveform energy curve 2726. Area 2746 is designated with the letters A and B showing that the energy in area 2746 is delivered by both a first shock vector (zone A) and a second shock vector (zone B). In accordance with the disclosed technique, the first shock vector is terminated and truncated at inversion point 2706 and the remaining energy of the first shock vector, area 2766, is added, or summated, to the energy of the second shock vector. Area 2766 is thus shown as zone B to indicate that this energy from the first shock vector is added to the energy of the second shock vector.
[0045] Graph 262C shows a waveform energy curve 272C truncated at an even later inversion point 270C as compared with inversion points 270A and 270B. An area 274C represents the energy of the first phase of waveform energy curve 272C whereas an area 276C represents the energy of the second phase of waveform energy curve 272C. Area 274C is designated with the letters A and B showing that the energy in area 274C is delivered by both a first shock vector (zone A) and a second shock vector (zone B). In accordance with the disclosed technique, the first shock vector is terminated and truncated at inversion point 270C and the remaining energy of the first shock vector, area 276C, is added, or summated, to the energy of the second shock vector. Area 276C is thus shown as zone B to indicate that this energy from the first shock vector is added to the energy of the second shock vector.
[0046] As shown in graphs 262A, 262B and 262C, the inversion point of the waveform energy curve can be shifted in the time domain to change when the first shock vector is truncated and its remaining energy is summated to the energy of the second shock vector. Graph 262A shows an early inversion point and thus a significant amount of energy transfer to the second shock vector whereas graph 262C shows a later inversion point and closer to the energy transfer shown above in
[0047] Reference is now made to
[0048] In addition, processor 310 may be programmed with an option for changing or shifting the inversion point of the applied shock vectors. As explained above in
[0049] Subcutaneous defibrillator 320 includes a body 322 and a plurality of electrodes 324A and 324B, similar to subcutaneous defibrillator 52 (
[0050] In one embodiment of the disclosed technique, for example with a subcutaneous defibrillator including a plurality of electrodes such as three or more electrodes (not shown), at least one of the electrodes can be disconnected at any given time during the delivery of a shock vector. By disconnecting at least one of the electrodes the energy distribution of the shock vectors to the heart can be directed as desired. Such an embodiment is possible when there are more than two electrodes.
[0051] By changing the inversion point timing sequence, the relative amount of energy delivered to each respective shock vector can be dynamically adjusted with the total amount of energy applied by the defibrillator remaining the same yet with its energy distribution being different for each shock vector. Using a numerical example, in a subcutaneous defibrillator which can apply electrical shocks of around 70 joules (i.e., the capacitor can hold sufficient energy to apply 70 joules in a given therapy session of applying electrical shocks), time domain shifting of the inversion point can allow 10 joules to go to one shock vector and 60 joules to the other shock vector, or 35 joules to each shock vector. The energy delivery balance between the two shock vectors can be adjusted such that the DFT is as low as possible while still remaining effective.
[0052] As mentioned above, processor 328 may be programmable with options for changing or shifting the inversion point of the applied shock vectors and turning the truncating/summating option of the two shock vectors on or off. Body 322 may include Bluetooth and/or infrared technology (not shown) for enabling a clinician to communicate with processor 328 via software. The software may be a computer application, smartphone application and the like. The decision regarding whether the truncating/summating option of the two shock vectors should be used and to what degree the inversion point should be shifted in time is patient specific and can be determined by the clinician. A number of visits by the patient to the clinician as well as follow-up sessions by the patient after implantation of his/her defibrillator can aid the clinician in determining if the truncating/summating option reduces the DFT and if time domain shifts of the inversion point reduce the number of arrhythmias experienced by the patient.
[0053] It is noted that the examples given above of the disclosed technique relate to defibrillators providing two shock vectors, however the disclosed technique can be applied to defibrillators providing three or more shock vectors. According to the disclosed technique, in a defibrillator applying more than two biphasic shock vectors, at least one or more of the biphasic shock vectors can be made uniphasic and terminated at its inversion point, with the remainder of its energy diverted and summated to the other biphasic shock vectors being applied. Furthermore, the inversion point in time of the shock vectors can be shifted for balancing the energy distribution between shock vectors traversing paths of different impedance.
[0054] Reference is now made to
[0055] In a procedure 356, the voltage inversion point of the biphasic defibrillating shock vectors is modified according to patient and defibrillator characteristics. Depending on the anatomy of the patient and the specific placement of the electrodes of the defibrillator (whether external, intravenously or subcutaneously), the truncating and summating of the energy of the first shock vector to the second shock vector may not be sufficient to balance the energy distribution between the shock vectors to lower the DFT and effectively defibrillate various parts of the heart. In this procedure, the voltage inversion point is shifted in the time domain, either forwards or backwards in time, to transfer either less or more energy from the truncated part of the second phase of the first shock vector to the second phase of the second shock vector. The amount of shifting of the inversion point is dependent on the patient's anatomy and the placement of the electrodes of the defibrillator in or around the patient's heart which can change the impedance of the path the shock vectors take between given sets of electrodes. Modifying the inversion point enables more energy to be delivered to the shock vector having to cross a path of higher impedance. After procedure 356, the method returns to procedure 350.
[0056] Procedure 356 can be applied many times until an ideal balance of energy between the two shock vectors is obtained and the DFT for effective defibrillation of a given patient is attained. As mentioned above, even though
[0057] It will be appreciated by persons skilled in the art that the disclosed technique is not limited to what has been particularly shown and described hereinabove. Rather the scope of the disclosed technique is defined only by the claims, which follow.