Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2001-03-23
2002-11-26
Bockelman, Mark (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S060000, C324S207160, C604S891100
Reexamination Certificate
active
06487452
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to “active medical devices,” and in particular to “active implantable medical devices,” as such devices are defined by the Jun. 20, 1990 Directive 90/385/CE of the Council of the European Communities. This definition includes cardiac pacemakers, defibrillators, cardiovertors and/or multisite devices, and neurological apparatus, diffusion pumps for delivering medical substances, cochlear implants, implanted biological sensors, etc., as well as devices for measurement of pH or intracorporeal impedance (such as transpulmonary or intracardiac impedance measurements). The invention also can apply in an advantageous manner to non-implanted active medical devices such as Holter recorders, which are portable recorders that are carried by the patient for a long period of time to allow the uninterrupted recording of electrocardiographic signals.
BACKGROUND OF THE INVENTION
Many active medical devices are designed to be sensitive to the placement of a permanent magnet in proximity to the device, which action causes the device to be placed in a predetermined operating mode or configuration. This may be done in order to test the device (or the patient) or to allow programming of the device (for example, by telemetry in the case of an implant).
This particular mode, often called a “magnet mode”, is a temporary operating mode, because many or at least certain of the otherwise established operating functions of the device are inhibited during the magnet mode. Typically also, the device does not present an optimum operation during the magnet mode phase.
It is essential for these active devices to detect the presence of the magnet in a reliable manner (i.e., with the best possible rejection of any disturbing phenomena), while minimizing the power consumption, which is an essential factor for autonomous (portable) medical implants that need to have the longest possible lifespan.
A first known technique for the detection of the presence of the permanent magnet uses a switch with a flexible shaft (known as a “reed switch”). The shaft moves in response to a magnet in proximity to switch a circuit within the device.
Another technique, to which the present invention refers, is taught by the U.S. Pat. No. 4,611,127, which uses an inductor-capacitor (“LC”) oscillating circuit in which the value of the inductance of the inductor coil decreases in the presence of a magnetic field. This resonant circuit is excited by a signal pulse and a circuit measures the oscillation frequency resulting from the LC circuit. In the presence of a magnet, the value of the inductance is reduced and as a result the oscillation frequency increases. Consequently, by monitoring the zero-crossing characteristic of the current in the resonant circuit within a defined sensing window, or by measuring, for example, the time it takes a voltage stored on the capacitor to pass to zero for the first cycle or half cycle of the pulse response, one can deduce a diminution in the value of the inductance, and, consequently, the presence of a magnet proximate to the inductor (also referred to herein as a coil).
The disadvantage of this known technique is its sensitivity to magnetic or electric interference. Indeed, strong intensity fields, such as those which are produced, for example, by anti-theft protection devices or microwave ovens, are able to produce a large magnetic field component that can be detected by the detecting circuit. This is because the magnetic interference component generated by these devices typically has the same effect on the coil and its associated circuit as the quasi-continuous field produced by a magnet.
The problem is made worse by use of the principle of measurement by sampling, which is adopted for reasons of saving energy, specific to active implants. Thus, in the case of an apparatus such as pacemaker, the determination of the presence of a magnet is carried out once each cardiac cycle. However, there is a risk that the implant, deluded by an alternate magnetic interference field of sufficient strength to modify the value of inductance, changes to operate in the magnet mode in a manner that is inappropriate, and perhaps harmful for health of the patient bearing the apparatus.
A strong intensity electric field also can induce interferences that are superimposed on the pulse response of the oscillating circuit, and in the same way, delude the circuit that measures the period of the cycle or half cycles, and affect its response.
OBJECTS AND SUMMARY OF THE INVENTION
It is, therefore, an object of the present invention to propose a circuit for detecting the presence of a magnet which eliminates, or at least substantially reduces the above-mentioned disadvantages.
The circuit of the present invention is of a known general type according to U.S. Pat. No. 4,611,127 mentioned above, i.e., including: a coil, able to cooperate with the aforementioned magnet so as to present a decreased value of its inductance in the presence of the magnet; a resonant LC circuit including the aforementioned coil; means for pulse excitation of the resonant circuit; means for analzing the pulse response of the resonant circuit; and discriminating means able to evaluate the inductance value of the coil from the analyzed pulse response and, correlatively, to determine the presence or the absence of the magnet. Suitable circuits for the foregoing are all described in the U.S. Pat. No. 4,611,127.
According to the invention, the pulse excitation means includes circuit means able to deliver to the resonant circuit a burst of N successive pulses, and the analyzing means includes circuit means able to determine the N corresponding pulse responses, and the discriminating means includes means able to determine the presence of the magnet if, among N analyzed pulse responses, a number M of them correspond to a decreased value of inductance of the coil. Preferably, M≦N, and more preferably M≧N/2.
More advantageously, the excitation means is operated in a manner whereby after having delivered a first pulse, it will continue thereafter to deliver the N−1 following pulses of the burst only if in response to the first pulse the analysis means has detected a pulse response corresponding to a decreased inductance value.
The excitation means optionally can include means for varying the moment of the delivery of the first pulse of the burst, and/or the intervals between the moments of delivery of the successive pulses of the same burst. The variation is preferably a pseudo-random variation and aids in discriminating interference.
When the active medical device is an implantable pacemaker, defibrillator, cardiovertor and/or multisite device, the successive pulses of the burst are preferably delivered over a duration that is shorter than the duration of a detected or stimulated cardiac cycle, as determined by the implant device.
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Bockelman Mark
Ela Medical S.A.
Orrick Herrington & Sutcliffe LLP
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