EP1971399A1 - Systeme de stimulation et en particulier regulateur de rythme cardiaque - Google Patents

Systeme de stimulation et en particulier regulateur de rythme cardiaque

Info

Publication number
EP1971399A1
EP1971399A1 EP06829714A EP06829714A EP1971399A1 EP 1971399 A1 EP1971399 A1 EP 1971399A1 EP 06829714 A EP06829714 A EP 06829714A EP 06829714 A EP06829714 A EP 06829714A EP 1971399 A1 EP1971399 A1 EP 1971399A1
Authority
EP
European Patent Office
Prior art keywords
magnetic field
electrode device
electrical
coil
stimulation
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.)
Withdrawn
Application number
EP06829714A
Other languages
German (de)
English (en)
Inventor
Erhard Kisker
Heinrich Wieneke
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.)
Universitaet Duisburg Essen
Original Assignee
Universitaet Duisburg Essen
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
Application filed by Universitaet Duisburg Essen filed Critical Universitaet Duisburg Essen
Publication of EP1971399A1 publication Critical patent/EP1971399A1/fr
Withdrawn legal-status Critical Current

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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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A61N1/3787—Electrical supply from an external energy source

Definitions

  • Stimulation system in particular pacemaker
  • the present invention relates to a stimulation system, in particular a pacemaker, an implantable electrode device or stimulation device for a stimulation system and a method for operating an implantable electrode device or stimulation device, in particular a pacemaker.
  • the present invention is not limited thereto, but generally includes stimulation devices that operate electrically and, in particular, deliver electrical impulses for stimulation.
  • Pacemakers stimulate the heartbeat by means of electrical impulses that are introduced into muscle tissue of the heart.
  • a pacemaker is usually implanted, for example, in the vicinity of the shoulder of the thorax, wherein at least one probe or electrical lead is guided by the implanted pacemaker via a vein into the atrium or the chambers of the heart and anchored there.
  • a problem or disadvantage is the electrical line. It runs with a length of about 30 cm in the bloodstream and can thereby cause unwanted or even fatal body reactions.
  • the risk of failure of the probes or lines is particularly high due to the strong mechanical stress during body movements due to material fatigue. Another complication that often occurs is the probe dislocation that is triggered by the patient's movements.
  • US 5,411,535 A discloses a pacemaker with an implantable controller and a separate electrode device. Between the control device and the electrode device are wireless - in particular electrical signals from 10 MHz to several GHz - transmitted to the control of the electrode device. The actual power supply of the electrode device takes place via a battery integrated into the electrode device. Such pacemakers with separate electrode device have not been successful. This may be because the electrode device has a considerable size and limited operating time due to the battery.
  • the wiring between the implanted coil and the electrodes spaced therefrom causes the same problems as in the conventional pacemaker described above in which at least one electrode is connected via an electrical lead connected to the implanted pacemaker through a vein.
  • the implantation of this pacing system requires the opening of the thorax and provides open heart surgery.
  • the implanted coil is very susceptible to external electromagnetic fields, so that unwanted spurious voltages can be induced to occur at the electrodes.
  • JP 06 079 005 A discloses an implantable cardiac pacemaker whose battery is inductively rechargeable via a coil from the outside.
  • US 5,405,367 A discloses an implantable microstimulator.
  • the microstimulator has a receiving coil, an integrated circuit and
  • Electrodes on. He is about an external magnetic field, that of an outer Coil with an associated Ostilator and an associated stimulation controller is generated, supplied with power and with control information.
  • Such a microstimulator is not suitable for cardiac stimulation or as a pacemaker, since it is built with sufficient capacity relatively large and requires an external power supply.
  • the present invention has for its object to provide a stimulation system, such as a pacemaker, an implantable electrode device or stimulation device for a stimulation system and a method for operating an implantable electrode device or stimulation device, in particular an electrical line to the electrode device in the implanted state is not required a simple and compact construction of the electrode device is made possible and / or wherein an insensitive to external influences energy transfer and / or control are possible.
  • a stimulation system such as a pacemaker, an implantable electrode device or stimulation device for a stimulation system and a method for operating an implantable electrode device or stimulation device, in particular an electrical line to the electrode device in the implanted state is not required a simple and compact construction of the electrode device is made possible and / or wherein an insensitive to external influences energy transfer and / or control are possible.
  • One aspect of the present invention resides in supplying energy to the implantable electrode device for generating electrical impulses, in particular exclusively wirelessly, over a temporally varying magnetic field and / or preferably also directly controlling it.
  • This allows a very simple and compact structure of the electrode device, in particular no cabling of the electrode device is required, so that the implanting simplified and the risk of failure of an electrical line is avoided, and in particular wherein the use of an energy storage device, such as a battery Battery o. The like., Can be avoided in the electrode device.
  • an energy storage device such as a battery Battery o. The like.
  • the magnetic field is preferably generated by an implantable control device, so external control can be avoided. This is special when using the stimulation system as a pacemaker desirable and much safer in use than a control by an external - not implanted - control device.
  • the electrode device is controlled directly by the time-varying magnetic field.
  • direct control is to be understood as meaning that the electrical impulses are generated by the electrode device directly as a function of the magnetic field, for example as a function of the height of the magnetic field, polarity of the magnetic field and / or rate of change of the magnetic field , particularly preferably without the interposition of an active electronic component in the electrode device. Consequently, electrical impulses or stimulations are generated in the preferred immediate control only temporally correlated to the magnetic field. This also allows a very simple and particularly compact construction of the electrode device and / or a very safe, defined control.
  • Another aspect of the present invention is to form the electrode device such that an electrical pulse is generated only when a minimum field strength of the magnetic field is exceeded. This allows in a very simple manner a safe, especially interference-insensitive control with a correspondingly high choice of the minimum field strength, since strong magnetic fields are extremely rare, electromagnetic alternating fields with different frequencies, however, are very common.
  • the electrode device must first be activated before another electrical pulse can be generated.
  • This activation takes place in particular by another signal - preferably by opposite field direction of the magnetic field - shortly before triggering and generating the next electrical pulse.
  • a two-stage control or signal generation is required to generate an electrical pulse by means of the electrode device.
  • This two-stage leads to a particularly safe - so insensitive to disturbance - control.
  • the aforementioned driving safety can be further improved or increased by the fact that the activation of the electrode device always takes place shortly before the generation of the next electrical pulse.
  • a high-turn coil device that is, a multi-turn coil, is employed to provide a high voltage electrical pulse of at least 0.5 V, preferably substantially 1 V or more, and a relatively long duration of time from at least 0.05 to 2 ms.
  • the coil device can in particular also have a soft-magnetic or ultra-soft magnetic core.
  • no continuous or long-lasting, for example, sawtooth rising magnetic field pulse of the control device but a plurality of short magnetic field pulses is generated when switching the magnetic field, in particular so that the coil core of the coil means or electrode means its magnetization always far changes below the state of saturation.
  • a minimum energy consumption can be achieved, especially if during the entire duration of the stimulation pulse (possibly also a coherent sequence of electrical impulses of the electrode device, this sequence is considered in the present invention as a single electrical impulse for stimulation) the greatest possible temporal Flow change takes place in the core of the coil device or electrode device.
  • the magnetic field pulses may be unipolar or bipolar when using soft magnetic core materials. When using bistable materials (especially Wiegand or pulse wires) bipolar magnetic field pulses must be used.
  • a direct electrical stimulation may also be effected by a magnetizable element.
  • the element is in particular a coil core without a coil or the like.
  • an implantable stimulation device comprises the magnetizable, preferably ferromagnetic element, wherein the magnetization of the element is varied by an external or varying magnetic field, so that the magnetic leakage flux of the element leads to the desired electrical stimulation or generation of an electrical pulse in the surrounding tissue.
  • the proposed electrode device or another electrode device can alternatively or additionally also be used to convert the action of the heart, in particular a movement of the heart and / or electrical activity of the heart, into a magnetic pulse or another, in particular electrical, signal preferably can be detected by the stimulation system or other receiving unit.
  • the implantable electrode device serves, in particular, for generating electrical signals for stimulating a heart.
  • the present invention is not limited thereto. Rather, the electrode device can generally generate any type of electrical pulses or electrical signals in the human or animal body.
  • the terms “electrode device” and “stimulation system” are accordingly to be understood in a very general sense, so that other applications and uses - such as for influencing the brain - to understand. Further advantages, properties, features and aspects of the present invention will become apparent from the following description of preferred embodiments with reference to the drawing. It shows:
  • Figure 1 is a schematic representation of a proposed stimulation system with a control device and an electrode device in the implanted state.
  • Fig. 2 is a schematic representation of the control device
  • FIG. 5 shows a schematic, sectional view of a core element of the electrode device
  • FIG. 6 is a schematic diagram of a magnetization curve of FIG.
  • FIG. 7 is a schematic diagram of the time course of a magnetic field and an induced voltage
  • FIG. 8 shows a schematic section of a further electrode device
  • FIG. 10 shows a schematic block diagram of a further proposed stimulation system with control device and electrode device as well as with a charging device;
  • FIG. 11 is a schematic diagram of the timing of on-drive pulses, a generated magnetic field, and a generated electrical pulse.
  • the same reference numerals are used for the same or similar parts, components and the like, giving corresponding or similar advantages and properties, even though a repeated description is omitted.
  • FIG. 1 shows, in a very schematic sectional view, a proposed stimulation system 1, which in the example shown is designed or operates, in particular, as a pacemaker.
  • the stimulation system 1 may additionally or alternatively also work as a defibrillator or be used for other purposes and in other places in the human or animal body.
  • the stimulation system 1 has a preferably implantable control device 2 and a separate, implantable electrode device 3.
  • the control device 2 is implanted, in particular in the chest space between the skin 4 and ribs 5.
  • the control device 2 can in particular be implanted as usual in modern cardiac pacemakers. However, implantation of the control device 2 is not absolutely necessary. In principle, the control device 2 can also be used in the non-implanted state-that is, as an external device-to control the electrode device 3.
  • the electrode device 3 can also be used independently of the control device 2.
  • the electrode device 3 it is possible in principle for the electrode device 3 to be supplied with energy and / or controlled by another device-possibly even by an MRI scanner or the like-with appropriate coordination. This opens up further application possibilities, which go far beyond the possible applications of previous pacemakers or other stimulation systems.
  • the electrode device 3 is preferably implanted in the heart 6 or the heart muscle of the patient, which is shown only in a very schematic and fragmentary manner.
  • the implantation of the electrode device 3 can be carried out, for example, as described in US Pat. No. 5,411,535 A.
  • 2 shows a schematic sectional representation of the control device 2.
  • the control device 2 a coil 7 for generating a magnetic field H, a controller 8 and preferably an energy storage 9, such as an accumulator on.
  • the coil 7 can optionally be provided with a ferromagnetic, soft or ultra-soft magnetic core or a half-sided sleeve or other shoe or guide element for concentrating the magnetic flux.
  • the control device 2 or controller 8 can preferably receive or record the required cardiac information via means and / or the coil 7, not shown, in order to generate electrical impulses through the electrode device 3 in order to stimulate the heart 6
  • control device 2 or its energy storage 9 is inductively rechargeable in the implanted state.
  • the coil 7, which is already provided for generating the magnetic field H is preferably used.
  • any other induction device, not shown, can be used for charging.
  • the electrode device 3 shows in a very schematic sectional view the proposed electrode device 3.
  • the electrode device 3 is preferably constructed only of passive components and / or without energy storage, such as a battery. In the illustrated embodiment, it preferably has a coil device 10, an otionale pulse shaping device 11 and preferably at least one electrode 12 - preferably at least two electrodes 12 - and preferably a common housing 13. The components and electrodes 12 are preferably integrated into or attached to the particularly electrically insulating housing 13.
  • the electrode device 3 is very compact and in particular substantially rod-shaped or cylindrical. In the illustrated example, the length is 10 to 20 mm, in particular substantially 15 mm or less. The diameter is preferably at most 5 mm, in particular substantially 4 mm or less.
  • a holding device can be attached to the electrode device 3, preferably an anchor or a screw, which makes it possible to anchor the electrode device 3 in the heart muscle.
  • the electrode device 3 is designed to generate electrical pulses for the desired stimulation or signal generation.
  • the electrical pulses are emitted, for example via the electrodes 12.
  • the electrodes 12 are arranged on opposite sides in the illustration example. However, the electrodes 12 may also be arranged, for example, concentrically with each other or otherwise at one end or at the opposite ends of the electrode device 3 or the housing 13.
  • the injection molding device 11 here preferably has a capacitance 14, in particular in the form of a capacitor, and a resistor 15. Additionally or alternatively, an inductance, not shown, such as a coil, can be used for pulse shaping.
  • the pulse shaping device 11 is used to form or reshape a pulse-like induction voltage, which under certain circumstances - as explained in more detail below - is generated or emitted by the induction or coil device 10.
  • the reshaped electrical pulse can then be output directly via the connected electrodes 12 for stimulation.
  • the induction or coil device 10 is preferably designed in such a way that a pulse-like induction voltage is generated when a minimum field strength of the electrode device 3 or coil device 10 is exceeded-ie, the external magnetic field -pulse-like induction voltage is exceeded.
  • the coil device 10 particularly preferably has a coil core 16 which, when the minimum field strength is exceeded, exhibits a sudden change in the magnetization, ie bistable magnetic properties. This abrupt change in the magnetization or magnetic polarization leads in an associated coil 17 to the desired pulse-like induction voltage.
  • the coil core 16 in the illustrated embodiment is preferably made up of at least one core element 18, in particular a plurality of core elements 18.
  • the core elements 18 preferably run parallel to one another, so that the coil core 16 is constructed like a bundle of the core elements 18. However, if necessary, only a single core element 18 can be used to form the coil core 16, in particular if the energy of the electrical pulse to be generated is relatively low or if another arrangement is used, for example with a plurality of coil devices 10.
  • the core element 18 is preferably designed as a wire.
  • the coil core 16 or the core element 18 preferably has a layer arrangement of soft and hard magnetic material.
  • an inner layer, such as a core 19, and an outer layer, such as the shell 20 are made of at least magnetically different materials, namely soft magnetic material, on the one hand, and hard magnetic material, on the other hand.
  • the differences thus lie in the coercive field or in different hysteresis curves of the (magnetically) different materials.
  • the coupling due to the layer structure then leads to the desired magnetically bistable behavior or the desired abrupt change in the magnetization of the core element 18 or of all core elements 18 and thus of the coil core 16.
  • the individual core elements 18 preferably have a diameter of about 50 to 500 .mu.m, in particular substantially 100 .mu.m, and / or a length of 5 to 20 mm, in particular substantially 15 mm.
  • Wiegand wires as core elements 18, as described in US Pat. No. 3,820,090 and / or by HID Corp., 333 St. Street, North, Heaven, CT 06473, USA, under the trade name "Wiegand Effect Sensors , or so-called impulse wires, as offered by Tyco Electronics AMP GmbH, Siemensstr. 13, 67346 Speyer, Germany.
  • the soft and hard magnetic layer are formed from the same material, wherein the different magnetic properties are achieved in particular by mechanical deformation.
  • the electrode device 3 for generating electrical pulses is preferably exclusively wirelessly supplied and / or controllable via a magnetic field H that can be generated, in particular, by the control device 2.
  • the electrode device 3 does not require energy storage, such as a battery that limits the life or usability of the electrode device 3.
  • the electrode device 3 is designed such that an electrical pulse is generated and released only when a (first) minimum field strength of the magnetic field is exceeded. Further, this or other pulse generation or triggering is preferably made possible only after respective previous activation.
  • the pulse generation and tripping preferably take place in that the external magnetic field H acting on the coil device is varied over time, so that when the first minimum field strength Hl is exceeded a sudden change in the magnetization of the core elements 18 or of the coil core 16 takes place, as in the schematic Magnetization curve indicated in FIG. 6. Due to the inverse Wiedemann effect, this abrupt change in the magnetization leads to a pulse-shaped induction voltage (pulse P in FIG. 7) in the associated coil 11. This first minimum field strength H 1 thus represents a switching threshold.
  • the induced voltage pulses P may have an amplitude of up to about 5 V and are about 5 to 100 ⁇ s long.
  • the optional pulse shaping device 11 is preferably used.
  • the induced voltage pulse P can be extended in time.
  • a longer pulse duration can also be achieved by bundling a plurality of core elements 18 in the coil 17, in particular so that the pulse shaping device 11 can be completely dispensed with.
  • additional core elements 18 may be provided in the spool core 16.
  • a plurality of coil devices 10 can be connected in parallel or in series to hear the pulse power.
  • the coil core 16 also other magnetic see, especially permanent magnetic elements for the realization of each desired magnetic properties of the spool core 16 are used.
  • the size of the minimum field strength H 1 depends on various factors, in particular also on the production conditions of the core elements 18.
  • the minimum field strength H1 is preferably between 0.5 and 20 mT, in particular between 1 and 10 mT, and is very particularly preferably about 2 mT. These values are already considerably higher than the values, which are usually admissible in the public domain, for magnetic fields, so that triggering of an electrical impulse by normally expected interference fields is ruled out.
  • the individual core elements 18 or the coil core 16 with the bistable magnetic properties - in particular in the preferred but not necessarily required structure of layers with alternating soft and hard magnetic properties - can be used in different ways.
  • an asymmetric behavior when passing through the magnetization curve or hysteresis is preferably achieved.
  • the coil core 16 is (completely) repolarized (completely) by the external magnetic field H with opposite field direction when the second minimum field strength H2 is exceeded, like the magnetization curve according to FIG can be seen.
  • the coil core 16 is (completely) repolarized (completely) by the external magnetic field H with opposite field direction when the second minimum field strength H2 is exceeded, like the magnetization curve according to FIG can be seen.
  • the weichmagneti- see material layers are repolarized in the above processes, the magnetization of the hard magnetic material layers are thus preserved. In principle, however, even higher magnetic fields H can be used in order to re-polarize the hard magnetic layers as required.
  • the outer magnetic field H generated in particular by the control device 2 thus serves in the preferred embodiment both to control (trigger) the generation and delivery of an electrical pulse by the electrode device 3 and to supply the electrode device 3 with the energy required to generate the electrical pulse ,
  • the magnetic field H is preferably also used for the aforementioned activation of the electrode device 3 for the possible generation of the aftermath. used most electrical impulse. However, this can also be done in any other way or by another signal.
  • the external magnetic field H preferably runs at least substantially parallel to the longitudinal direction of the coil core 16 or the core elements 18.
  • FIG. 7 schematically shows a preferred time profile V 1 of the external magnetic field H acting on the electrode device 3 and of the corresponding time curve V 2 of the voltage U induced in the electrode device 3 or its coil 17.
  • the magnetic field H is preferably generated intermittently and / or as an alternating field.
  • the magnetic field H has a duty cycle of less than 0.5, in particular less than 0.25, particularly preferably substantially 0, 1 or less.
  • the field strength of the magnetic field H runs - at least during the switch-on times - substantially ramp-like or sawtooth-shaped, as indicated in Fig. 7.
  • the magnetic field H is alternately generated in the opposite field direction for alternately generating an electrical pulse and activating the electrode device 3 before generating the next electrical pulse.
  • the activation takes place only shortly before the generation of the next electrical pulse, as indicated in FIG. 7.
  • the frequency of the magnetic field H is preferably only a few Hz, in particular less than 3 Hz, and corresponds in particular to the desired frequency of the electrical pulses to be generated.
  • the ramp-shaped increase of the field strength of the magnetic field H preferably takes place in each case relatively steeply in order to achieve only short switch-on times and only a low switch-on ratio. This is advantageous in terms of minimizing the required energy and to a defined triggering with little interference.
  • the field strength of the magnetic field H in the region of the electrode device 3 at maximum preferably reaches essentially 1 to 20 mT, in particular 2 to 10 mT.
  • Electrodes 3 which are in particular controlled by a common control device 2 and supplied with energy.
  • the electrode devices 3 can then be implanted at different locations, for example.
  • desired phase shifts, energy differences or the like can then also be achieved in the electrical pulses or signals emitted by the individual electrode devices 3.
  • the galvanic can be detected via the housing of the control device 2 or a related electrode - can be realized.
  • the coil device 10 can here have a coil core 16 or core elements 18 made of a soft magnetic or ultra-soft magnetic material - for example in the form of wires or strips. Such material has a very low coercive field strength, which corresponds to the minimum field strength Hl and in particular less than 0, 1 mT. The saturation field strengths of the material are less than about 0.01 to 3 mT.
  • the winding core 16 is made of nonmagnetic or wholly or partly of said soft magnetic or ultra-soft magnetic material or of a combination of different such magnetic materials.
  • the electrode device 3 or coil device 10 here has a coil 17 with a preferably high number of turns, in particular of at least 1,000 turns, particularly preferably of 2,000 turns or more.
  • the coil 17 has in particular substantially 3000 turns or more.
  • the coil inner diameter Dl is preferably 1 to 3 mm
  • the coil outer diameter D2 is preferably 2 to 6 mm
  • the coil length Ll is preferably 10 to 30 mm.
  • ferrites or ferromagnetic metallic powder materials can also be used as core materials or soft magnetic materials.
  • core materials or soft magnetic materials One advantage is that these materials show only low eddy current losses because of the poor electrical conductivity.
  • the yarn bobbin or its bobbin core 16 shown in FIG. 8 or only its center rod or only a rod-shaped core 16 or even a plurality of core elements 18 made of soft or ultra-soft materials in the form of a stack can be electrically insulated from one another Foils to reduce the transverse conductivity to reduce eddy current losses.
  • the proposed electrode device 3 or coil device 10 allows the generation of a relatively strong electrical pulse, in particular a pulse having a voltage of at least 1 V and a time duration of substantially 0, 1 ms or more. This can be achieved in particular by the illustrated yarn package-like design and / or by the high number of turns. In particular, this relatively strong and relatively long-lasting electrical pulse can also be achieved with the soft magnetic core material.
  • a magnetic reset pulse, as in the Wigand wires or the like, is not necessarily required. However, a combination with the other magnetic materials or structures is possible.
  • the exciting magnetic field H can only increase relatively slowly (typically in 0.1 to 5 ms from 0 to a maximum value of, for example, 0.1 to 2 mT).
  • a relatively wide or long-lasting pulse with a duration of at least 0.1 ms, in particular of essentially loan 0.25 to 2 ms be generated. This may possibly be due to the AC characteristics of the LRC device (or coil device 10, large inductance and high winding capacitance of the coil) and / or the feedback of the coil current to the core 16.
  • the electrode device 3 described above is preferably in turn combined with the already described control device 2 or another control device 2 or preferably exclusively controlled and / or supplied with energy via an external or varying magnetic field H, as already described.
  • FIG. 9 shows a further embodiment of the proposed electrode device 3. More specifically, this is not an electrode device 3, but a stimulation device 21, since no electrodes 12 as in the previous embodiments are required.
  • the stimulation device 21 can be used instead of the electrode device 3 or for the above-described stimulation system 1 are used.
  • the previous statements with regard to the use and the use of the electrode device 3 thus apply to the stimulation device 21 in principle accordingly.
  • the stimulation device 21 has a magnetizable element 22, which is preferably surrounded by an optional sleeve 23. Electrodes 12 or the like, as in the electrode device 3, are preferably not required.
  • the element 22 can be magnetized by an external or varying magnetic field H, in particular the magnetic field H is generated by the control device 2 or in any other suitable manner.
  • the magnetic field H By varying the magnetic field H, a change in the magnetization of the element 22 is effected. Accordingly, the stray magnetic flux of the element 22 in the tissue surrounding the stimulation device 21 in the implanted state, such as the heart 6, is varied over time, whereby an electric field strength or an electrical stimulation is generated. Consequently, without electrodes 12, an electrical stimulus is generated in the tissue, such as the heart 6.
  • the element 22 is ferromagnetic, in particular made at least substantially or exclusively of ferromagnetic material.
  • the element 22 may also be constructed as described with reference to FIG. 5 and / or constructed as a Wigand wire or the like and / or from a plurality or a bundle of core elements 18.
  • the stimulation device 21 effects a reinforcement of the external magnetic field H at the location of the stimulation device 21, that is to say at the implanted point. This allows a targeted electrical stimulation in the desired range and / or in dependence on the magnetic field H.
  • the control device tion during the duty cycle of the magnetic field H - ie during the switch-on phases - each generate a plurality of short magnetic field pulses as a result.
  • the coil assembly 10 or its coil core 16 always changes its magnetization far below the state of saturation.
  • a minimal energy consumption can be achieved because during the entire duty cycle of the magnetic field H and thus substantially during the generation of the electrical pulse as large a flux change in the core of the coil assembly 10 of the electrode device 3 is present or produced.
  • the magnetic field pulses may be unipolar or bipolar when using soft magnetic core materials. When using the bistable materials bipolar magnetic field pulses are used.
  • bipolar magnetic field pulses are preferably generated by means of a bridge of switching transistors M1 to M4 (for example MOSFETS, also in complementary execution) or other switching semiconductor components.
  • the coil 7, the controller 8 and the energy storage 9 of the control device 2 are indicated.
  • the controller 8 may, for example, have one or two signal generators V2 and V4.
  • a smoothing capacitor 25 is connected in parallel to the energy store 9.
  • a disconnect electronics 26, such as a switch or the like, may be provided.
  • the control device 2 or its coil 7 is preferably designed such that the control device 2 or its energy storage 9 in the implanted state inductively, in particular via the coil 7, is rechargeable.
  • the charging device 24 with a suitable coil 27 and a corresponding power supply, in particular AC power supply 28, equipped.
  • Fig. II a shows a schematic diagram of a possible pulse sequence (voltage over time t), which is generated by the controller 8 and allows optimal control of the bridge.
  • the drive pulses - here for the bridge of switching transistors - are preferably only during the switch-on time t on to t off , that is, during the activation of the magnetic field H, testifies.
  • the drive pulses each last less than 50 ⁇ s.
  • a first pulse 1 (shown in solid lines) and a certain delay time of, for example, ⁇ t
  • Exclusive- ter pulse 2 which reverses the primary coil voltage (voltage of the coil 7) via the bridge.
  • This alternating generation of drive pulses repeats n times until a sufficient number of pulses consisting of positive and negative, paired individual pulses has been delivered.
  • the illustrated drive pulses or pulse sequences result in a sequence of, in particular, at least substantially sawtooth-shaped, preferably bipolar magnetic field pulses (shown as current through the coil 7 over the time t in FIG. 11 b) which are applied to the electrode device 3 or their coil device 10 (secondary coil) act as a magnetic field H in the context of the present invention and there cause the generation of an electrical pulse (or a series of electrical pulses for a single stimulation) for stimulation.
  • Fig. 11 c) shows schematically as a voltage over the time t one of the magnetic field pulses or the pulse-like varying magnetic field H generated electrical see pulse (in particular an overlay of partially smoothed individual pulses).
  • the length of the electrical pulse depends on the length of the duty cycle of the drive pulses or the magnetic field pulses, and particularly preferably corresponds essentially to the duty cycle.
  • the time duration between two drive pulses .DELTA.t should be selected so that the second pulse is triggered when the primary quasi-initially decreasing quasi-linearly in the direction of zero reaches the zero level.
  • This period of time depends both on the R / L value of the coil 7 and on the R / L value of the secondary circuit, in particular of the coil arrangement 10.
  • the primary circuit control device 2
  • essentially the winding resistance and the inductance of the coil device 10 determine the R / L ratio, while the resistance of the coil device 10 is determined by the winding resistance.
  • the resistance and stress resistance tissue resistance of the stimulated part of the heart muscle or the like, which abuts the electrodes 12
  • the inductance is determined by the winding inductance taking into account the preferably ferromagnetic core 16.
  • R here generally denotes the electrical resistance
  • L the inductance.
  • the pulses induced in the coil means 10 have different signs in the times t and t ', respectively.
  • This results in a pulse train of bipolar pulses (both in unipolar and in bipolar excitation by magnetic field pulses).
  • unipolar electrical impulses are needed or generated.
  • the rectifier is preferably connected between the terminals of the coil device 10 and the electrodes 12, as indicated in Fig. 10.
  • a small smoothing capacitor C2 (of, for example, 1 to 100 nF) connected in parallel with the stimulation electrodes can smooth this pulsating voltage sequence, if necessary.
  • the capacity value can be optimally adapted to the properties of the overall system.
  • the electrode device 3 is preferably constructed only of passive, in particular a few components, such as one or more diodes, in particular Schottky diodes D2, D5, D8, D9, for forming the rectifier and / or the capacitor C2.
  • the duration of the respective electrical pulse (of a single stimulation) generated by the electrode device 3 depends on the respective switch-on duration of the magnetic field H, in particular on the number of drive pulses generated in a sequence, and thus also on the number of pulses the control device 2 generated magnetic field pulses. Consequently, the control device 2 controls the generation of the electrical impulses or the electrode device 3 by the magnetic field H directly in the aforementioned sense of the present invention.
  • the schematic diagram according to FIG. 11 c) shows the influence of the rectification and the R / L ratio of the coil device 10 of the electrode device 3.
  • the coil voltage follows the derivative of the primary coil current d 1 / dt , which preferably increases or decreases in a linear manner as a result of the smaller R / L ratio of the primary coil (coil 7) when the primary coil voltage is reversed.
  • a low RTL ratio of the coil means 10 including the tissue resistance applied to the electrodes 12
  • this increases induced coil voltage (as a voltage at the load resistance of the coil 17 - in particular so at the voltage applied to the electrodes 12 tissue resistance - measured) only relatively slowly.
  • the proposed method relatively short, closely spaced rectified electrical impulses due to a sequence of short magnetic field pulses or drive pulses shown in FIG. 1 1 to stimulate a single heartbeat or the like.
  • Use also offers the possibility of an external influence on the with at least a suitable sensor equipped control 8 the stimulation pulse duration (total length of the electrical pulse during a duty cycle of the magnetic field H, substantially on time t o "to t off ) to adapt to the needs of each patient by the number n of the pulse pairs of the drive pulses is set accordingly.
  • the stimulation pulse duration total length of the electrical pulse during a duty cycle of the magnetic field H, substantially on time t o "to t off
  • the described induction pacemaker technology can also be used in combination with conventional pacemaker technology.
  • the use for left ventricular stimulation in the context of resynchronization therapy makes sense.

Abstract

L'invention concerne un système de simulation, un dispositif d'électrodes implantable et un procédé de conduite d'un dispositif d'électrodes implantable. L'invention permet de simplifier l'implantation avec une structure simple et une commande sûre par le fait que le dispositif d'électrodes est alimenté et commandé exclusivement sans fil par un champ magnétique qui varie dans le temps. Le champ magnétique est créé par un dispositif de commande implanté.
EP06829714A 2006-01-13 2006-12-18 Systeme de stimulation et en particulier regulateur de rythme cardiaque Withdrawn EP1971399A1 (fr)

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US20120179219A1 (en) 2012-07-12
WO2007087875A1 (fr) 2007-08-09
US20090024180A1 (en) 2009-01-22
US8321021B2 (en) 2012-11-27

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