Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/056—Transvascular endocardial electrode systems
  • A61N1/057—Anchoring means; Means for fixing the head inside the heart

Definitions

• the present invention relates to an electrode catheter for pacemakers for both left and right ventricular electrostimulation.
• a bi-ventricular electrostimulation i.e., a stimulation directed at both ventricles. This occurs in those cases in which it is essential to ensure a perfect synchronism between the contractions of the two ventricles, the right one and the left one.
• the purpose of electrical therapy is to improve the mechanical performance of the heart by means of a re-synchronization of the ventricular activity obtained with a different sequence of activation.
• the right and left ventricles are stimulated in order to minimize intraventricular mechanical delay and synchronize opening of the pulmonary and aortic valves.
• Biventricular electrical stimulation can be guided by a sinus rhythm (DDD mode) or, in patients with atrial fibrillation, can be conducted with the WI mode. Stimulation of the left ventricle can be obtained both with epicardial electrodes and with endocardial electrodes.
• the epicardial approach which is far more invasive and involves greater risks of arrhythmic complications, is not very much used.
• endocardial approach which, notwithstanding the considerable improvement in materials, can present some DE1455PTWO PCT/IB2008/051839
• Pacemakers and defibrillators are apparatuses based upon a parallel-circuit configuration, which simultaneously enables functions of sensing and pacing of the two ventricles, with different programming modes (unipolar or bipolar).
• the therapy of cardiac re- synchronization is technically feasible, safe and reliable, as it is witnessed by the increasing number of implantations.
• the effectiveness of this type of electrical therapy in the marked improvement of the haemodynamic parameters and the left- ventricular-ejection fraction of patients with cardiac decompensation has been ) demonstrated in a series of studies.
• biventricular pacing has proven able to reduce the degree of mitral rigurgitation and reduce the left ventricular volumes, thus configuring a phenomenon of inverse remodelling of the left ventricle.
• biventricular pacemaker has induced other non-negligible positive effects, such as an easier optimization of the multipharmacological therapy, and a significant reduction in hospitalizations due to cardiac decompensation.
• bi- ventricular stimulation requires, in addition to implantation of the atrial electrode catheter, the implantation of two ventricular electrode catheters, one in the right ventricle and the other, for the left ventricle, in a superficial branch of the great cardiac vein, which is reached by the electrode catheter through the coronary sinus.
• DE1455PTWO PCT/H32008/051839
• the second electrode for stimulation of the left ventricle, in the case of a biventricular stimulation, is quite a complex operation.
• Said positioning involves the use of special instruments for the introduction and the use of a contrast liquid for the radiological observation of the operation.
• the aim of the present invention is thus to overcome the aforesaid drawbacks by providing an electrode catheter structured so that its insertion in the right ventricle will enable bi-ventricular electrostimulation without the need for implantation of a second DE1455PTWO PCT/IB2008/051839
• the aim of the electrode catheter according to the invention is to make available a structure made in such a way as to enable bi-ventricular electrostimulation, overcoming the need to use two ventricular electrode catheters, in association, as is the usual case, with the atrial electrode, hi addition, another aim of the present invention is to provide an electrode catheter for bi-ventricular electrostimulation that can be positioned without any difficulty and in a stable way over time, thus solving the inconveniences of the prior art.
• Figure 1 is a side view of the electrode according to the present invention, in a position of use;
• Figure 2 is a cross-sectional view of the electrode catheter; and Figure 3 illustrates the optimal positioning of the electrode catheter within the heart.
• the electrode according to the present invention is a single electrode catheter with sliding coaxial spirals 20, 40, 60 for univentricular and biventricular cardiac stimulation, the electrode comprising the following parts:
• An instrument of this sort enables elimination of the problem linked to the necessary use of two different electrodes, one for the left ventricle, the other for the right ventricle, which complicates considerably application of the pacemaker. It is, in fact, an electrode ) with three coaxial spirals, within which the spindle slides, as indicated in Figure 2.
• Elongation of each spiral according to a pre-set maximum length enables the stimulation tips 1, 2 to position themselves optimally at the right height of the ventricle, thus offering the advantage of a simpler arrangement and hence a more immediate operativeness.
• the maximum distance between the tip 1 and the tip 2 is comprised between 8 mm and 10 mm, which is the usual thickness of the interventricular septum.
• the maximum distance between the tip 2 and the ring 3 is comprised between 25 mm and 35 mm in such a way as to enable an effective return of stimulation signals.
• a spindle 10 of adequate dimensions constitutes the load-bearing shaft of the electrode bestowing thereupon just the right rigidity for introduction of the tip into the interventricular septum.
• the turns 20, 40, 60 are separated by an insulator 30, 50, 70, as illustrated in the cross section represented in Figure 2.
• the bi-ventricular stimulation electrode according to the present invention can be inserted according to normal surgical procedures within the right ventricle and then pushed, via elongation of the turns 20, 40, 60, through the interventricular septum up to the left ventricle.
• this electrode and the presence of the appropriate spindle facilitate said operation.
• the tip 1 can present various configurations: it may be conical, shaped like a fixed screw, or shaped in some other way so as to enable a greater penetration through the interventricular septum.
• the spindle is threaded in the internal part of the tip 1 so as to render it stiffer to facilitate the step of its introduction into the interventricular septum.
• the tip 2 is constituted by a ring having a circumference comprised between 3 mm and 7 mm and is crimped to the spiral 40.
• the ring 3 instead, is crimped to the spiral 60 and has a circumference comprised between 10 mm and 15 mm.
• the optimal configuration of positioning is the one indicated in Figure 3, which is obtained automatically once the tip 1 is well positioned in the interventricular septum.

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• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Electrotherapy Devices (AREA)

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• 2007
  • 2007-05-11 DE DE202007018527U patent/DE202007018527U1/de not_active Expired - Lifetime
• 2008
  • 2008-05-09 WO PCT/IB2008/051839 patent/WO2008139396A2/en active Application Filing
  • 2008-05-09 EP EP08751188A patent/EP2155321A2/de not_active Withdrawn

Non-Patent Citations (1)

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