Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1998-12-22
2001-06-26
Layno, Carl H. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S005000
Reexamination Certificate
active
06253106
ABSTRACT:
FIELD OF THE INVENTION
The present invention concerns “active implantable medical devices” such as those defined by the Jun. 20, 1990 directive 90/385/EEC of the European Community Council, particularly devices such as cardiac pacemakers, defibrillators and/or cardiovertors capable of delivering a low energy electrical stimulus to the heart for the treatment of the so-called “troubles of the cardiac rhythm,” namely cardiac arrhythmias.
The invention concerns more particularly the so-called “multisite” prostheses, that is prostheses in which electrodes are placed in a plurality of distinct respective sites, of which at least two are ventricular sites. These prostheses can be of the “single chamber” (double ventricular stimulation), triple chamber (right atrial stimulation and double ventricular stimulation) or even quadruple chamber (double atrial stimulation and double ventricular stimulation) type. The electrodes are connected to independent outputs of the pacemaker in a manner that permits the detection of depolarization potentials, as well as the application of stimulation pulses.
BACKGROUND OF THE INVENTION
Multisite cardiac pacemakers are known. EP-A-0 030 897 describes such multisite pacemakers, in which there are two outputs and the corresponding stimulation electrodes are implanted in two predetermined sites belonging to the same cardiac cavity, notably the ventricle. A switching device allows one to choose the functioning mode of the pacemaker among various modes (bipolar, double unipolar, double unipolar or bifocal ventricular), nevertheless without modifying the implantation of electrodes and the choice of stimulation sites.
OBJECTS AND SUMMARY OF THE INVENTION
It is an object of the present invention to propose a cardiac pacemaker (or a stimulation circuit for a defibrillator or cardiovertor) of the multisite type allowing, without any notable increase of the complexity of the pacemaker circuit, to modify the choice from among the installed sites by researching, (i.e., evaluating and/or determining) an optimal stimulation configuration. Indeed, when one modifies the configuration of stimulation sites after a certain time, one detects (observes) a best recovery of the muscular tonus of the myocardium, and therefore a reduction of the effort required to be provided by the muscle.
For the treatment of dilated cardiomyopathy, the goal is to have several poles of stimulation. The ability to be able to modify the configuration is a distinct practical advantage provided by the present invention.
The multiplication of the number of sites normally would entail a correlative multiplication of the number of stimulation circuits and detection circuits, that would reach rapidly the constraints imposed by the available space inside (volume) the case of the pacemaker, given the increase of the number of components. In addition and especially, the increase of the number of components would induce a significant increase of the current consumption of the pacemaker, susceptible to reduce the nominal life duration of the pacemaker to below the required limit (or require more powerful and likely larger batteries).
The present invention aims to solve these aforementioned difficulties, by proposing a configurable multisite, active implantable medical device, preferably a pacemaker, endowed with a stimulation/detection capacity that is susceptible to stimulate and to detect according to multiple configurations, and modifiable at will, while minimizing the quantity of necessary components. Thus, the invention seeks to realize a compromise between, on the one hand, clinical requirements and, on the other hand, constraints of volume inside the implant case and constraints of circuit construction and energy consumption.
To this end, the present invention is directed to an active implantable medical device, in which electrodes are placed in at least three distinct myocardial sites for stimulation, of which at least one site is a ventricular stimulation and ventricular detection site. These electrodes are connected to independent outputs of the device in a manner to allow the application of stimulation pulses produced by a plurality of distinct stimulation stages (i.e., low energy pulse generating circuits), which circuits are in number at most equal to the number of stimulation sites. The invention is characterized in that it also comprises a commutation means, i.e., a network of switches, to connect selectively and according to one of a number of various possible stimulation configurations, the stimulation stages, or selected ones of the stimulation stages, to the various stimulation sites, or to selected ones of the stimulation sites, and a means of controlling the commutation means, to modify the stimulation configuration in a manner as to research the configuration considered to be optimal.
This device also can comprise at least two distinct detection stages (cardiac event detection circuits) for the detection of spontaneous electrical activity in a cardiac cavity, in which the commutation means comprises, in addition, means for connecting selectively and according to one of a number of various possible detection configurations the detection stages, or selected ones of the detection stages, to the various stimulation sites or to selected ones of the stimulation sites which connection(s) to a detection stage may or may not be concurrent with a connection to a stimulation stage. In other words, a detection stage may be connected to the same site as a stimulation stage, but not every site connected to a stimulation stage is also connected to a detection stage.
Advantageously, the means of control of the commutation means can operate dynamically during functioning of the device, in a manner as to modify the configurations for the stimulation and/or detection, and the device comprises in addition means for evaluation of the result obtained by each selected configuration to perform the aforementioned research of an optimal configuration.
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Bouhour Anne
Legay Thierry
Ripart Alain
ELA Medical S.A.
Layno Carl H.
Orrick Herrington & Sutcliffe LLP
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