Implantable Pulse Generator Having Rectangular Shock Waveform

Abstract

The present invention relates an implantable pulse generator comprising an electric circuit, wherein the electric circuit comprises: a primary energy store, at least one secondary energy store, and a control unit, wherein the control unit is configured to activate an electric switch in the electric circuit in such a way that, in a first interval of a first phase of a pulse delivery, the primary energy store is discharged via a therapeutic current path, and to activate an electric switch in the electric circuit in such a way that, in a second interval of the first phase of the pulse delivery, the secondary energy store is discharged via the therapeutic current path, wherein the primary energy store and the at least one secondary energy store are fixedly connected, or connectable, in series, and wherein the implantable pulse generator is designed to deliver a shock having an approximately rectangular pulse waveform.

Claims

1. An implantable pulse generator comprising an electric circuit, the electric circuit comprising: a primary energy store; at least one secondary energy store; and a control unit, the control unit being configured: to activate an electric switch in the electric circuit in such a way that, in a first interval of a first phase of a pulse delivery, the primary energy store is discharged via a therapeutic current path, and to activate an electric switch in the electric circuit in such a way that, in a second interval of the first phase of the pulse delivery, the primary energy store and and the at least one secondary energy store are discharged via the therapeutic current path, the primary energy store and the at least one secondary energy store being fixedly connected, or connectable, in series, wherein the implantable pulse generator is designed to deliver a shock having an approximately rectangular pulse waveform, the implantable pulse generator comprising a plurality of secondary energy stores, and the control unit is further configured to activate an electric switch in the electric circuit in such a way that, in the second interval, the primary energy store and, consecutively, all secondary energy stores are discharged via the therapeutic current path, or the primary energy store and in each case one of the plurality of secondary energy stores are discharged via the therapeutic current path.

2. The implantable pulse generator according to claim 1, wherein the electric circuit comprises a plurality of secondary energy stores, the primary energy store and the plurality of energy stores being fixedly connected, or connectable, in series, and the control unit being configured to activate one or more electric switches of the electric circuit in such a way that the secondary energy stores are sequentially or consecutively discharged via the therapeutic current path in the second interval of the first phase of the pulse delivery.

3. The implantable pulse generator according to claim 1, wherein the control unit is further configured to activate at least one electric switch, preferably a plurality of switches of a bridge circuit, in a second phase of the pulse delivery in such a way that the direction of current in the therapeutic current path is reversed.

4. The implantable pulse generator according to claim 1, wherein the primary energy store is composed of a plurality of individual energy stores that are fixedly connected in series or connectable in parallel with one another.

5. The implantable pulse generator according to claim 1, wherein the switch or switches of the electric circuit is or are electronic switches, in particular selected from: an insulated-gate bipolar transistor (IGBT), and anode gated thyristor (AGT), or a combination of the aforementioned electronic switches.

6. The implantable pulse generator according to claim 1, wherein the electric circuit comprises between two and four secondary energy stores.

7. The implantable pulse generator according to claim 1, wherein the primary energy store and/or the secondary energy store or energy stores, independently of one another, are a capacitor or a coil.

8. The implantable pulse generator according to claim 7, whereinn the plurality of secondary energy stores are formed by a capacitor comprising at least one electrode having a first polarity and at least two second electrodes having a second polarity, each electrode being electrically contactable separately from one another from the outside of the capacitor.

9. The implantable pulse generator according to claim 1, wherein: the primary energy store has a capacitance in the range of 150 μF to 300 μF and/or a nominal voltage in the range of 250 V to 255 V, and/or the secondary energy store or the secondary energy stores has or have a capacitance in the range of 180 μF to 360 μF and/or a nominal voltage in the range of 250 V to 255 V, independently of one another.

10. A method for delivering an electrical pulse having a substantially rectangular voltage waveform (pulse waveform), comprising the following steps: connecting a charged primary energy store to a discharge current path in a first interval of a first phase of a pulse delivery; and connecting a plurality of secondary energy stores to the discharge current path in a second interval of the first phase of the pulse delivery, the primary energy store and the at least one secondary energy store being fixedly connected, or connectable, in series, and in the second interval, the primary energy store and, consecutively, all secondary energy stores being discharged via the therapeutic current path, or the primary energy store and in each case one of the plurality of secondary energy stores being discharged via the therapeutic current path.

11. The method according to claim 10, wherein a plurality of secondary energy stores are connected to the discharge current path in the second interval of the first phase of the pulse delivery.

12. The method according to claim 11, wherein: only one secondary energy store at a time is connected to the discharge current path, in particular each of the plurality of secondary energy stores being consecutively connected to the discharge current path, or the plurality of secondary energy stores are sequentially connected to the discharge current path, in particular all secondary energy stores being consecutively connected to the discharge current path.

13. The method according to claim 10, wherein the connection of the primary energy store and of the at least one secondary energy store or of the plurality of secondary energy stores is carried out in each case by way of a switch, and in particular by way of an electronic switch.

14. The method according to claim 10, wherein the direction of current in the therapeutic current path is reversed in a second phase of the pulse delivery.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0088] Further features and advantages of the present invention are described hereafter based on the description of the figures of exemplary embodiments. In the drawings:

[0089] FIG. 1 shows various shock waveforms of implantable defibrillators and the effect on the transmembrane voltage of cardiac muscle cells;

[0090] FIG. 2A shows an embodiment of a circuit according to the present invention comprising primary and secondary energy stores that can be connected in series;

[0091] FIG. 2B shows the associated voltage waveform of the therapy voltage and of the energy stores (top), and the effect thereof on the transmembrane voltage of the cardiac muscle cells (bottom);

[0092] FIG. 2C shows a detailed representation of the embodiment shown in FIG. 2A;

[0093] FIG. 3A shows an alternative embodiment of a circuit according to the present invention comprising primary energy stores connectable in series and secondary energy stores connectable in parallel;

[0094] FIG. 3B shows the associated voltage waveform of the therapy voltage and of the energy stores (top), and the effect thereof on the transmembrane voltage of the cardiac muscle cells (bottom); and

[0095] FIG. 4 shows an alternative embodiment of a circuit according to the present invention, using capacitors comprising multi-anodes contactable from the outside.

DETAILED DESCRIPTION

[0096] FIG. 1 shows the state of the art (top graph, classic) of the shock waveform of an implantable defibrillator (applicable both to transvenous and subcutaneous ICDs). The therapy voltage results from the discharge of effectively only one capacitor and therefore drops exponentially. This has the disadvantage that the process has to begin with considerably higher starting voltages so as to generate the same effect in the heart. For comparison, the ideal waveform of a shock having a rectangular first phase is shown (rectangular), as well as the shock waveforms of the approach according to the present invention, which approximate the rectangular waveform.

[0097] FIG. 2A shows a preferred embodiment of the circuit according to the present invention, in which the energy stores C.sub.1 to C.sub.6 are capacitors that are connected, or can be connected, in series. The capacitors C.sub.1 to C.sub.3, which form the primary energy store according to the present invention, can also be implemented as a capacitance C.sub.0. All capacitors C.sub.1 to C.sub.6 can essentially be charged simultaneously by a charging circuit. The switches S.sub.1 to S.sub.4 are switched consecutively in ascending order for delivering the therapy. Switch i is opened again in the process before switch i+1 is closed. This circuit further feeds the H-bridge for the generation of the second phase (not shown). One of the switches, preferably S.sub.4, is closed in the second phase. Instead of switch S4, it is also possible for a diode to be arranged, which blocks the current in the direction C.sub.0/C.sub.4. FIG. 2B shows the voltage waveform of the therapy voltage achievable with this electric circuit, as well as at the capacitors C.sub.0, C.sub.4, C.sub.5, C.sub.6 in the top illustration, and the corresponding effect on the transmembrane voltage of the cardiac muscle cells in the bottom illustration. The primary energy store C.sub.0, which is formed of three individual energy stores C.sub.1 to C.sub.3, preferably has an overall capacitance in the range of 150 μF to 300 μF, and each of the secondary energy stores C.sub.4 to C.sub.6 preferably has a capacitance in the range of 180 μF to 360 μF.

[0098] FIG. 2C shows an implementation of the embodiment shown in FIG. 2A comprising electronic switches and up to 6 capacitors as energy stores C.sub.1 to C.sub.6 of the pulse generator according to the present invention. Of these, 3 capacitors C.sub.1, C.sub.2, C.sub.3 ensure the sufficiently high starting voltage, and the remaining 3 capacitors C.sub.4, C.sub.5, C.sub.6 generate the desired approximately rectangular pulse waveform (saw tooth curve), which in the present case can have up to 4 spikes. So as to render the shock biphasic, an H-circuit comprising the electronic switches (IGBTs) Q05 to Q08 is conventionally used. This circuit is fed via the electronic switches (IGBTs) Q01 to Q04, which activate the capacitors C.sub.4, C.sub.5, C.sub.6. The IGBTs Q02 to Q04 are preferably protected against polarity reversal by way of the diodes D7 to D9. The shock is conducted into the body via the terminals HV1 to HV2. The capacitors are charged via a high voltage source, which is connected to HVin and ground.

[0099] FIG. 3A shows a further preferred embodiment of the electric circuit according to the present invention comprising capacitors C.sub.1 to C.sub.6 as energy stores, wherein the activated, or activatable, energy stores C.sub.4 to C.sub.6 are connected, or connectable, in parallel with one another. The capacitors C.sub.1 to C.sub.3 can also be implemented as a capacitance C.sub.0 here. All capacitors are essentially charged simultaneously by a charging circuit. The switches S.sub.1 to S.sub.4 are switched consecutively in ascending order for delivering the therapy. Switch i is opened again in the process before switch i+1 is closed. This circuit further feeds the H-bridge for the generation of the second phase. One of the switches, preferably S.sub.1, is closed in the second phase. FIG. 3B shows the voltage waveform of the therapy voltage achievable with the electric circuit, as well as at the capacitors C.sub.0, C.sub.4, C.sub.5, C.sub.6 in the top illustration, and the corresponding effect on the transmembrane voltage of the cardiac muscle cells in the bottom illustration.

[0100] FIG. 4 shows a preferred embodiment of the electric circuit according to the present invention comprising a parallel approach, using capacitors comprising multi-anodes K, A.sub.1, A.sub.2, A.sub.3 as the primary energy stores C.sub.0, C.sub.1, C.sub.2, C.sub.3 and multiple secondary energy stores C.sub.4 to C.sub.6. In particular, capacitors are used in the process which each comprise a cathode K and, for example, three anodes A.sub.1, A.sub.2, A.sub.3, wherein the cathode K can advantageously be contacted from the outside by an electrically conductive housing, and the anodes can be contacted from the outside separately from one another, and electrically insulated from one another and from the housing G, for example via feedthroughs D.sub.1, D.sub.2, D.sub.3. The multiple secondary energy stores according to the present invention are thus implemented as a capacitor, which provides three capacitances that can be discharged separately from one another with the three separately contactable anodes A.sub.1, A.sub.2, A.sub.3 thereof

[0101] However, it would also be conceivable that the capacitors C.sub.1 to C.sub.3, which form the primary energy store according to the present invention, are designed in such a way that the anodes A.sub.1, A.sub.2, A.sub.3 are electrically connected in the interior of the housing G, and can be electrically contacted from the outside via a shared anode wire, which is routed to the outside via a feedthrough, for example.

[0102] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.