FR3022789A1 - DEVICE FOR FIXING AND REMOVING A STIMULATION ELECTRODE - Google Patents

Abstract

The device consists of a stimulation electrode (7) provided with a retractable fastening system (24) on command in body tissues and a mobilization and displacement means of the stimulation electrode constituted by a steerable catheter (34) whose distal end allows the body of the electrode to be grasped, which serves as a guide for a rod T1 (26) intended to actuate by means of a pushbutton (31) the retractable fastening (24) of the electrode.

Description

The present invention relates to a new device for stimulating muscle tissue or nerve tissue (including nerves, nerve endings and tissues associated with axons or in the central nervous system) and more particularly a system of fixation and removal of a stimulating electrode in muscle or nerve tissue. The present invention describes novel means for attaching and removing one or more stimulation electrodes in muscle or nerve tissue. The subject of the present invention is also a device implementing these new means as well as a complete system for implanting and explanting or removing a stimulation electrode of the probeless or wired type. coordinated method of operation between several electrodes without probe which makes it possible to limit the energy consumption of the 2 electrodes without probe. The present invention also relates to a method of controlling the concerted operation between at least two pacing electrodes without probe, with or without fixation and withdrawal means for their implantation or explantation of the muscular or nervous tissue. A probeless or wireless electrode system is described by way of example in European Patent Application EP 2,537,555. Similarly, for illustrative purposes, a wire electrode system is disclosed in US Patent Publication No. 5 411,535 or US patent application US 2007/088398 or US 2011/0251660. A stimulating electrode is defined as a device for depolarizing cells of the target tissue (e.g., muscle or nerve tissue including peripheral nerves and cranial nerves) by means of an electrical current created by the device or externally supplied to the device or else via an energy recovery system. A stimulation probe is defined as an electrical conductor for connecting a pacing electrode to a control box generating a transmittable electrical pulse to the pacing electrode when necessary. At present, the stimulation of the muscular tissues, and in particular of the striated heart or muscles, involves means external to the body of the individual, human or animal, constituted by a box containing the energy and all the parameters necessary for the treatment. completion of the device spot as well as a stimulation electrode.

The two elements can communicate via a stimulation probe or by non-wire means. The assembly constituted by the housing and by the stimulation electrode forms a pacemaker (also called Pacemaker) in the case of heart. The means described in the prior art generally consist of a box characterized by its ability to control the rhythm of the heartbeats by comparing the data transmitted from the heart to a control element of the housing with the normal values and to apply a regularization of these beats if necessary by sending to the electrode implanted in the tissue in question, adequate instructions by WiFi or any other non-wired means or by means of a stimulation probe associated with the electrode. Wireless or non-probe electrodes are described without a box with standalone operation isolated from the electrode. There is currently no energy or low-cost means for operating two wireless or probeless electrodes or multiple probeless electrodes. in a coordinated way. The electrode is fixed in the prior art by means rigid to the target tissue by means of a screw retractable by a screwing or unscrewing movement applied to the electrode either directly or through Another method of fixing the electrode can be achieved by means of a non-retractable anchor which is fixed within the asperities of the target tissue, for example the core. Such devices comprise in addition to a housing as described above, electrical son and one or more stimulation electrodes. These devices have been the subject of patents or patent applications such as US5 411 535 and US2007 / 088398 or US 2011/0251660. Pacemaker explantation systems have been described for example in the patent application US 2012/0165827 but have many disadvantages and above all have no way to reach the implanted material if it is covered with amorphous tissue in its totality by the development of fibrosis. In the patent application US 2012/0165827, there is described a device for explantation of a wireless or non-probe cardiac pacing electrode constituted by a probe provided with one or more lassos at its distal end hooked on the wireless pacemaker electrode 2 without probe at a dedicated end. In this prior patent application, there is no question of a retractable fastening device, for example of the push-button type, with regard to the means for fixing the wireless electrode or without a probe. It is described only passive or active screw type means and barbs. In addition, this device necessarily requires a fastening means for the specifically dedicated lasso on the electrode. The commercial cord stimulation electrodes do not provide any solution to several major disadvantages that have not yet been solved. Thus, one of the disadvantages of the current devices is the lack of choice and control of the precise area where the stimulation electrode will be implanted, particularly in cardiac resynchronization therapy (CRT) where it is necessary to stimulate a or several areas of the left ventricle via stimulation delivered into the coronary sinus. As a result, the positioning of the stimulated area is directly dependent on the anatomy of the patient's coronary sinus. This can lead to operational difficulties that may lead to failure of the therapy or the need to perform cardiac surgery to implant the left ventricular stimulation probe in the epicardial position which may induce or a loss of luck (impossibility to benefit therapy) or surgical complications of cardiac surgery (pericardial effusion, infection, hematoma). Another disadvantage of current devices (wired and non-wired) is that they offer no simple and low-risk solution for repositioning the electrode when it is implanted (especially for more than six months or if it is covered wholly or partially by fibrosis) or its complete withdrawal which in the first case implies a situation comparable to a definitive sealing of the electrode in whole or in part in the tissue: indeed, there is a risk of adhesion of the stimulation probe to the surrounding tissues (for example the superior vena cava, the subclavian vein, the wall of the right atrium ...) and mobilization of the stimulation probe in thrombosis of the subclavian vein which presents a significant risk when mobilizing or moving the stimulation probe for repositioning or extraction (cardiac or vascular wound or embolic). Thus, practitioners sometimes waive the dysfunctional electrode and prefer to leave the old set in place and prefer to re-implant a new system which can be expensive and increases the risk of infection on the equipment (the risk is proportional to the volume implanted equipment and the volume of initial equipment left in place). A final disadvantage of the electrodes without probe is the need for coordinated operation of two electrodes without probe according to a programming adapted by those skilled in the art. This coordinated operation is very energy-consuming which poses a problem of durability of the implanted devices. The advantage of this coordinated operation is to improve the performance of the heart function by allowing better filling of the heart chambers (due to a contraction order adapted in time) and a better cardiac output in the end. Several patents describe partial removal means stimulation probes such as US 4,574,800 and US 5,011,482, but none suggests or provides solutions to remove the entire stimulation device including the electrode in full in the case of a wireless or probeless pacing electrode or a wire pacing electrode if inadvertently the pacing electrode remained fixed in the heart due to a break between the probe body and the pacing electrode. In addition, the system described in US patent application 2012/0165827 is inoperative in case of total recovery of the system or in case of recovery only the means for attaching the electrode with fibrosis. This is not the case in the present invention where the electrode can still be removed by the implementation of the means of the invention. European Patent Application No. EP 2,537,555, entitled "Self-contained lead-free intracardiac implant with detachable fixing element", describes a probe-free cardiac stimulation device consisting of a pedestal implanted in the associated myocardial and non-mobilizable wall. to a stimulation electrode without probe. It is not described or suggested the possibility of removing the stimulation base, only the electrode is dissociable from its base.11 is also not specified the means / devices used to dissociate the electrode of its base . In this patent application, the wireless or probeless stimulation electrode is not functional without the implanted base, resulting in a total volume of material to be implanted greater and an increase in the surgical difficulty of setting up the implant. such a device with respect to a device that would possess the entire fixation system located on the electrode itself. The object of the present invention is to solve these problems of implanting and explanting stimulation electrodes and more particularly -Ge-which-concerns electrodes without probe. The present invention also relates to a method of moving a car. I-010. 'nal anchoring and its anchoring in the target area. This method comprises a first positioning of the electrode in the muscle tissue, said electrode comprising a de-fixing device. A second step of the method consists in fixing the stimulation device in the muscular tissue by implementing a retractable-ouigable-to-order fixing device constituted by means comprising components operating in a coordinated manner such as blades or solid or hollow rods capable of being fixed on command on the target tissue of the electrode which will be detailed below. The positioning and gripping means of the electrode is constituted by one or more components operating in a coordinated manner such as a multidirectional movable, removable and steerable gripper or a "glove" type gripping object possibly allowing to mobilize or move the electrode. There is therefore a union between the pluridigitée clamp and the electrode when the pluridigitée gripper surrounds the stimulation electrode. Consequently, the clamp-electrode assembly is orientable and movable under the same conditions as the clamp itself, and therefore only forms a single object (FIG. This makes it possible to bring the stimulation electrode to its place of implantation precisely and without limitation as a result of restrictive anatomical considerations (for example an absence of a coronary sinus target vein for cardiac resynchronization). The retractable fixing means and explantation or removal of a stimulation electrode according to the invention is for example constituted by a stimulation electrode comprising slides, rods or microtubes or retractable nanotubes.Les blades, rods, microtubes or nanotubes are formed of metallic or non-metallic materials. Blades, rods, microtubes or nanotubes may be preformed (or may have shape memory) and retractable or foldable upon control. The arrangement of the rods, slides or microtubes or nanotubes on the stimulation electrode is chosen to present the best compromise between steric hindrance in or on the electrode and the fixing efficiency of said electrode with the target tissue to be stimulated. The present invention relates to a set of devices comprising at least one stimulation electrode having at least at one of its ends a retractable or foldable hooking means according to the invention, a housing containing all the parameters necessary for the operation of the device. device and communicating with the stimulation electrode in a slave / master relationship respectively and possibly stimulation probes and means for gripping or moving the stimulation electrode. Once the fixation site is reached, a T1 rod (26) is brought to the electrode to activate the deployment of slides (24) (or stems, or microtubes or nanotubes) that can be preformed by via a pushbutton (31) having a locked position (blades / rods / microtubes / nanotubes in the out-of-electrode position) and an unlocked position (blades / rods / microtubes / nanotubes in the retracted and incorporated position) in whole or in part in the electrode). A new application of the rod T1 (26) makes it possible to move the fixing system from one position to another in an alternative way to deploy out of the body of the electrode or retract the slides or rods or microtubes or nanotubes inside the body of the electrode in whole or in part. The T1-activated fastening means (26) is of the push-button type (31). The following description comprises and describes advantageous variants of the invention without being considered as reducing or limiting the invention but on the contrary illustrate certain implementations. The entire device according to the present invention is constituted by at least two of the following elements: a muscular stimulation electrode having a retractable fastening means on command especially cardiac comprising a ferromagnetic material or a paramagnetic material or a combination of ferromagnetic materials and paramagnetic in the composition of said electrode, said electrode having a retractable or collapsible fixation and explantation means according to the invention, 6 -a muscular stimulation electrode without a probe, in particular a cardiac catheter, said electrode having a fixing means and a retractable explantation on command or foldable according to the invention, a steerable probe comprising an electromagnet type material (SEM) -a means of electrostatic generator type external to the body of the patient for contacting the stimulation electrode with a probe orientable having at its end di stale the polarization induced by the electrostatic generator by means of electrical wires from the electrostatic generator and contained in the probe. a box comprising all the parameters necessary for the proper functioning of the electrode and enabling communication with a system external to the patient's body making it possible to modify the reference operating parameters of the electrode. The box is connected to the electrode by a wired means or by WiFi -a multididigitée pliers whose fingers can deviate or approach on command (34). an object of shape-type shape-memory glove The complete system of fixing and retracting comprises the following means by way of illustration of the invention: According to a preferred embodiment, the present invention relates to a medical or veterinary device of the muscular stimulator type or nervous (including peripheral nerves and cranial nerves or the central nervous system), for example cardiac, without implanted endovascular stimulation probe and more particularly a medical or veterinary device comprising apparatus for implantation and explantation of a system muscle or nervous stimulation (including the central nervous system, cranial nerves and peripheral nervous system) concerning the portion of the implanted system in contact with the target tissue to be stimulated by the human or animal patient (including cardiac or nervous tissue ). A particular embodiment of the invention will now be described with a description of the means for mobilizing the electrode (the multi-digittal gripper (34)) and a description of the retractable fastening system of the invention. electrode provided at the point of optimal stimulation.This description is not limiting and on the contrary covers all variants of the invention or functional equivalent: We will now describe a particular mode of operation of the pluridigitée clamp (Figures 9A, 9B, 9C, FIG. 10, FIG. 1): The pluridigitated forceps (34) consists of a coating analogous to orientable electrophysiology probes. It also has a cylindrical push button (35) at its end closest to the operator that is out of the patient's body. This push button (35) typically has a portion of its length indentation so that it can play the role of rack on this part.Au level of the rack portion of the push button there are several independent gears playing the pinion gear in the rack / pinion system formed with the pushbutton.These same wheels are each connected via a belt to complementary wheels located at the other end of the clamp so that each wheel / pinion is connected to a pinion. distal wheel (F1 (40) and F1 '(50) in the case of a 2-wheel distal system) via a belt by wheel torque (belts 1 (39) and 1' (44) respectively). Distal wheels typically have a diameter equal to each other and smaller than that of the wheels acting as a pinion. The wheels F1 (40) and F1 '(50) form a gear with another wheel G1 (48) and G1' (49). ) respectively in a characteristic manner ue (in the case of a 2-wheel system). Again, the diameter of the wheels G1 (48) and G1 '(49) is less than or equal to that of F1 (40) and F1' (50). The wheels G1 (48) and G1 '(49) have an equal diameter. Characteristically, the wheels G1 (48) and G1' (49) are connected with the fingers 1 (42) and 1 '(46) respectively. so that the movement of the push button (35) will deviate from its axis the finger of the clamp or return it to its original position.

In addition, at the inner end of the push button, there is typically a spring K5 (51) which exerts a restoring force on the push button to return it to the neutral position (ie with the fingers of the forceps closest to the central axis of the forceps). The push button can not be pushed out of the gripper by means of an anti-return cleat (47). Finally, in a particular embodiment, there exists inside the clamp, one or more passages for rods T1 and T1 '(in the case of 2 rods) or more that will specifically press each of the push buttons of the element B (6) of the electrode fixing system which will be described below (there may be a passage through element B to activate the stimulation electrode). In a preferred embodiment, the stem T1 (26) has at its distal end a gear on all of its faces. In this preferred embodiment, the rod T1 (26) activates a rack which will allow the deployment of the fastening system. pressing the element B through a device that will be described below.In case of several fasteners, the rod T1 (26) can put in motion several racks as there are elements of fixation on the electrode). In another preferred embodiment, the rod T1 is in the central axis of the pluridigitée clamp and will allow to activate a push button (31) common to all the fasteners setting in motion each element Cl (10) positioned at the periphery of the electrode of each of the fastening elements by means of a support rod (30) making them integral with the pushbutton (Figure 9B). In a last preferred mode, the rod T1 (26) will press a push button (31) in the central position of the electrode.The latter will activate all the different elements of each of the fastening systems positioned near the central axis of the electrode (FIG. 9C). Of course, it is mentioned above that a description with 2 fingers to the clip but the invention relates to all possible variants comprising, inter alia, a larger number of fingers and the manner of their implementation. movement. We will now define precisely the operating mode of the fixing system of the stimulation electrode. The description is an exemplary embodiment and should be understood to encompass all functional equivalents. It is constituted by a push-button type system (31) associated with a column of elements rotating a plurality of toothed wheels which will be further detailed later allowing the exit and retraction of the fastening elements of FIG. the electrode on the target tissue (33) at each activation of the push button by external and command solicitation: The push button system consists of five elements described below (Figures 2A and 2B, Figure 3): The first element A (5) is constituted by a cylindrical cavity of variable diameter at both ends. The cavity is open at both ends denoted El (8) and E2 (25). By definition, E1 (8) has a larger diameter than E2 (25). Within the cavity of A (5) are the other 4 elements of the device. Within the cavity of A are crenellated portions CR (27) having the same height and width from one slot to the other. The slots are located in the same major axis as that of the element A. There is also at El (8) a cleat TA (9) perpendicular to the major axis of A (5). The second element B (6) is at the end El (8) of A (5) .11 has a diameter equal to that of the cylinder. It has a solid cylindrical shape whose coating is marked by complementary depressions to crenels CR (27) so that B can slide in A between CRs under the impulse of an external thrust (FIG. 4, FIG. 5, FIG. . In fact, CR slots (27) have a longitudinal guiding role of B (6) within A (5) and no degree of rotational freedom from B to A is possible. In addition, B has in its portion in contact with El (8) a complementary depression TA cleat (9) which prevents B (6) out of A (5) by the end El (8). At the other end of B (6) is a toothed wheel R1 (12) whose teeth D1 (28) are all inclined on the same side. One can imagine a variant of B advantageous where the element B would be separated into 2 elements (one close to El (8) named C1 (10), and another close to the element C (7) described hereinafter named C2 (12) of the same size and whose characteristics are unchanged (size, depressions ...) compared to their description above.These 2 elements would be connected by a spring K2 (11) .Thus, during the push of the external applicator on Cl (10), the spring K2 (11) would be stressed and Cl would approach C2 When the external applicator would withdraw, Cl would be pushed to the stop (TA) by the spring K2 that the system The third element C (7) is constituted by two wheels R2 (18) and R3 (21) connected to each other by a rod. central T2 (19), R2 (18) being the closest to B. R2 and R3 are toothed on each of their face the Closer to El (8) .Tub T2 has a degree of freedom at R3 by allowing rotation around the T2 axis by definition. Element C (7) is located in series following element B (6). R2 (18) has an indentation complementary to that of R1 (52). The angulation, the width of the base b2 (17) and the height of the teeth D2 (52) of R2 h2 (16) may be different from D1 (b1 (13) and h1 (14) respectively). R2 diameter (18) is less than or equal to that of R3 (21) (Fig 7, Fig 2, Fig 3). In an advantageous case, the teeth of R2, D2 (52) have a height smaller than that of R1 or the teeth of R2 are beveled. Thus, in a characteristic element of the invention, when B is in thrust, R1 and R2 are found face to face, resulting in the sliding of the tooth R2 on RI which leads to the rotation of C with respect to B. degree of rotation of C with respect to B is a function of the angulation and the height (h1 and h2 respectively) and their width (bl and b2 respectively) of the teeth of R1 and R2. In addition, typically, the slots (CR) stop at the T2 level. At this level, the CRs have a shape inclined in a direction identical to the teeth of R1. The rotation of R2 on R1 is calculated so that the pitch of rotation is less than or equal to the space between each slot CR so that R2 can slide again between CR slots. Indeed, when B is no longer in thrust, the teeth of R2 will again slide on the inclined reliefs CR until arriving in the space separated by 2 consecutive CR (that is to say the groove of Thus, the element C will move from a space between 2 CR to the next following each setting in motion of the system. When the thrust of T1 on B puts in longitudinal movement R2, the rotation occurs when R2 exceeds the upper part of the CR The second wheel R3 (21) of C has half the number of teeth D3 (29) present in R2.R3 has a star shape with a circular body and branches. The body of R.sub.3 is smaller than that of R.sub.2 but has at its branches a diameter equal to or discreetly smaller than that ofA in order to allow it to be set in rotary motion.The teeth of R.sub.3 (29) are located at the ends of the branches. of R3, typically the teeth of R3 are flat o beveled or discreetly inclined. The shims CA (20) are aligned with the teeth of R1 by construction and are located at the wall of A facing the element C. They have in their center means for housing the teeth D3 of R3 in the locked position , for example a depression in their center.The thickness of the wedges CA is calculated to allow the passage of the circular body of R3 during the thrust of the element C by the element B. The branches of R3 are arranged so that when the element C is in the free position, that is to say without stress (and the internal fixing elements to the electrode), they are not located in the same alignment along the longitudinal axis of A that the shims CA. Conversely, once the thrust of C by B and thus the rotation of C carried out, the branches of R3 become aligned with the shims CA along the longitudinal axis of A once in 2 (there are twice as many R3 teeth than R2 teeth and the number of AC wedges is identical to that of teeth D3). Thus, typically, when C is in rotation (following a thrust of B), the teeth D3 are in this position aligned with shims (CA) alternating with the only wall of A. (Figure 2, Figure 3, Figure 8a and Figure 8b) .The role of the wedges CA is to block in the pushed position the teeth of R3 (and thus the element C) alternatively a push on 2.Thus, alternatively, the element C is found in the locked position (when the teeth of R3 are in front of CA) and in the free position (when the teeth of R3 are not in front of CA and the element C can slide in the space between 2 CR) . The element 4 (D) (FIGS. 2A and 2B, FIG. 3) consists of a rod T3 (24) which may be metallic or not or formed of a composite material. T3 is formed of a pre-formed blade or tube or micro tube or nanotube. T3 ideally has a hook or anchor shape or any other means of attachment to the target tissue (33) .T3 is in solidarity with C at the level of R3, ideally at its center. The other end of T3 is at the E2 end (25) of A. At this point, E2 has a hole communicating the inside of A with the outside. The diameter of this hole is characterized by a diameter equal to 12 that of T3 making it possible to completely occlude the cavity containing T3 blocking in the free position of the system (that is to say when the rod T3 is in the retracted position in ). The element 4 receives an element 5 which is a spring K1 (22) situated around T3 and which extends along T3 between the upper pole of R3 and a TB orifice (23) situated on the path of T3, of which the diameter allows us to pass only Tate diameter_cie_Kt is between the diameter of A and that of E2. Thus, in the locked position, the spring K1 is stressed and the rod T3 is out of the element A taking its native form (hook for example). The spring has a stiffness such that the return force is less than the resistance of blocks (CA) blocking R3. On the other hand, in the open position (that is to say at the next external activation), the spring Ki provides mechanical energy to bring the rod T3 into the element A and push the element C into position It is noted that the energy provided by the spring KI makes it possible to release the rod T3 from adhesions that could be present at the attachment site. In an advantageous form of the invention, the electrode contains several fastening systems according to the type of the invention which makes it possible to multiply all the attachment points of the electrode on the target tissue. In addition, in a preferred embodiment, it is possible to include numerous variants of the invention without limiting the scope thereof: for example, it is possible to add a tight and fixed or integral film on the element A at El which allows to mobilize B with a tightness of the system. In another preferred mode, in the "retracted" position, T3 has a length such that it is equal to the distance between E2 and the center of the toothless end of R3. Another advantageous variant of the invention relates to the use of means for locating and mobilizing a wireless stimulation electrode or without a fibrotic-coated probe in association with the device according to the invention: It is possible to use a probe (Sil steerable used routinely by those skilled in the art in electrophysiology.This probe S1 further comprises a contacting means between the probe S1 and the stimulation electrode according to the invention which can be achieved by means of an electromagnet positioned at the distal end of the probe S1 and activated on demand which allows the contact of said probe with the stimulation electrode containing a ferromagnetic or paramagnetic element or both materials. the invention relates to another means for bringing the stimulation electrode into contact with a probe S2 which is orientable and of a similar nature to the probes marketed in electrodes. ophysiology (for example the "Mariner" probe produced by Medtronic USA) and having the characteristic of being associated with an electrostatic generator which activates the distal end of the probe S2 by polarizing it or with positive or negative charges This polarization makes it possible to establish an attachment with the electrode if the electrode is entirely or partially covered by an electrical insulating element, which makes it possible, when the probe S2 comes close to the insulated area, to polarize the electrode and to fix or make integral the electrode and the probe S2. It being understood that the heating obtained distally either with the electromagnet or with the electrostatic generator can be controlled by an irrigation of this distal end well known to those skilled in the art. When the fixing between the probe Si (or S2) and the electrode is carried out, the probe S1 (or S2) can be used as an internal guide for a sheath large enough to allow to encompass the assembly formed by an electrode. always implanted stimulation and probe S1 (or S2). Once this set has been put in place, it is possible to bring the pluridigated forceps into the lumen of the sheath in contact with the implanted electrode and then the rod Ti of the present invention is brought into the vicinity of the stimulation electrode as described herein. -above. It is then possible to repeat the reverse operations to those described above to obtain the retraction of the electrode fixation system to the target tissue. Once these have been retracted, it is possible thanks to the pluridigitated forceps to withdraw the whole of the stimulation electrode without leaving at the site of implantation any trace of the device implanted previously.

14 Legends of the Figures Figure 1: frontal cut centered on the right heart with example of setting in situation of the pluridigitée gripper containing a cordless electrode or without probe. Body of the pluridigitée forceps (1), finger 1 for fixation of the pluridigitée forceps (2), finger 1 'for fixing the pluridigitée forceps (3), wireless electrode or without probe (4), tricuspid valve (53). Figure 2 A: longitudinal section passing through the major axis of a variant of a fastener in the locked position where the element B is subdivided into 3 parts C1, C2 and K2. Element A (5), Element B (6), Element C (7), E1 (8), TA (9), Cl (10), K2 (11), R1 / C2 (12), b1 (13), h1 (14), guide groove (15), h2 (16), b2 (16), R2 (17), T2 (19), CA (20), R3 (21), k1 (22), TB (23) ), T3 (24), E2 (25), T1 (26), D1 (28), D2 (52), D3 (29). Figure 2B: longitudinal section passing through the major axis of an electrode fixing element in the extended / locked position. Element A (5), Element B (6), Element C (7), E1 (8), TA (9), Cl (10), K2 (11), R1 / C2 (12), b1 (13), h1 (14), guide groove (15), h2 (16), b2 (17), R2 (18), T2 (19), CA (20), R3 (21), k1 (22), TB (23) ), T3 (24), E2 (25), T1 (26), D3 (29). Figure 3: Longitudinal section passing through the long axis of a fastening element of the electrode in the retracted / free position. R3 has the same diameter as R2 because of the rotation along the major axis of the induced electrode to move from the "output" position to the "retracted" position. The zone of R3 (D3) in contact with CA (20) is no longer in the plane of section and allows element C to be able to pass below the limit of (20) in the direction of El (8) under initial pulse of K1 (22).

Figure 4: Section perpendicular to the major axis of the fastener A through C1. The guide zone of the element B is noted thanks to the CRs (27). CR (27), TA (9). Figure 5: section perpendicular to the major axis of the fastener A through R1. Note the guide area delimited by the CR (27) not allowing rotation of the element B during the thrust of Ti. CR (27), R1 (12) Figure 6: section perpendicular to the major axis of the fastening element A passing through the teeth D1 of R1. The teeth D1 are present in the guide space of the element B. D1 (28), CR (27). Figure 7: section perpendicular to the major axis of the fastening element passing through R2 (18). We note the empty spaces (53) of the same size as the CR at the levels of R2 in the continuity of the CR in the retracted position. Figure 8a: section perpendicular to the major axis of A in the "locked" position passing through CA. The teeth D3 are confused with the shims CA. Figure 8b: section perpendicular to the major axis of A in "retracted" position with R3 at the same level as CA. Note that the teeth D3 are in the free position with respect to the CAs, which allows the whole of the element C to be able to pass below the level of the CAs. Figure 9 A: Diagrammatic representation of the deployment of the wireless or probeless stimulation electrode with the help of the multidirectional clamp. Example with 2 fixing elements positioned at the periphery of the electrode.

16 T1 (26), Support Rod (30), Central Push Button (31), Element B (6), Element C (7), T3 (24), Stimulator Electrode Body (contains the set of the electrode except the fixation system) (32), target tissue to stimulate (33), pluridigitated forceps (34). Figure 9B: section perpendicular to the major axis of the stimulation electrode passing through the central pushbutton (case of the support rod) with 3 fixing elements positioned at the periphery of the electrode. Support Rod (30), Central Push Button (31), Stimulation Electrode (32). Figure 9C: section perpendicular to the major axis of the stimulation electrode passing through the central button (case of the push button common to all fasteners which are located near the central axis of the electrode). In this case, the support rod is virtual and the total steric hindrance is reduced. Figure 10: Longitudinal section passing through the long axis of the pluridigitic forceps (example with 2 gripping fingers). Push-button of the clamp (35), rack (36), gear 1 (37), pinion 1 (38), belt 1 (39), Wheel F1 (40), gear 2 (41), finger 1 (42) , gear 1 '(43), belt 1 (44), gear 2' (45), finger 1 '(46), spring K5 (51), anti-return cleat (47). The present invention relates to a method of controlling the coordinated operation, consuming a low energy level, of several electrodes including or not a fixing system and means for fixing or removing a wireless electrode or without probe (wireless ). The assembly is a wireless cardiac stimulation device or without probe having one or more electrodes to operate optimally to the needs of the patient. The method for controlling the coordinated operation of at least two wireless or sensorless electrodes according to the invention makes it possible to reduce the energy consumption of the electrodes concerned. The current emitted by each electrode is much higher in energy compared to the current produced by the core to produce a depolarization. In general, it is characterized by a Voltage of 1 to 2 Volts emitted by the electrode for a duration of 0.5 milliseconds (ms) with low amperage less than 40 milliamps (mA). This electrical activity of the electrode 17 is very different from that which the heart spontaneously emits via a potential of physiological action (cell resting potential at -70 mV (milli volts) which becomes positive with a maximum towards 30 mV during 1 to 2 ms). This makes it easy to differentiate between two different electrical activities: one spontaneous and the other artificial, both in their duration of emission and their voltage. This differentiation is for example carried out using a suitable filter incorporated into the system of 2 electrodes or any other treatment of the electrical signal detected by the electrodes. This detection will be performed by a system known to those skilled in the art and equipping devices currently marketed or any other device more suitable in the case of a wireless electrode or without probe. The signal thus detected will benefit from a signal processing making it possible, for example, to differentiate a detected signal greater than 0.5 V for a duration greater than 0.3 ms and less than 1 ms, of a signal less than 0.2 V. and greater than 0.01V emitted for a duration greater than 1.1 ms. The energy emitted by one of the electrodes is detected by the other or the others regardless of their location in the heart given the fact of the importance in developed energy. As an illustration is described the case of two wireless or probeless electrodes, one electrode is positioned in an atrium (right or left) and the other wireless electrode or without probe in a ventricle (right or left). The method is applicable for a multitude of electrodes operating in a coordinated manner. The wireless or sensorless electrode of the atrium, when it stimulates, will emit a stimulation current that will be detected by the electrode positioned in the ventricle. The ventricle electrode will then emit a stimulated atrioventricular delay (AVAD) to define when the electrode positioned in the ventricle must emit a stimulating current. The electrode positioned in the ventricle then determines a ventricular-atrial delay ( VA) which corresponds to the moment when the electrode positioned in the atrium should emit a stimulating current again. If the electrode positioned in the atrium (or atrium) emits again a current of stimulation, one starts again on the same If no pacing current is detected by the ventricular electrode, the ventricular electrode will assume that a spontaneous electrical activity has been detected by the electrode positioned in the atrium and will have caused its inhibition. in the ventricle will then reduce its operating cycle (ie increase its discharge frequency) according to a challenge setting for example, 1 beats per minute and trigger ventricular pacing earlier than its initial programming predicts. The electrode positioned in the atrium will then detect the stimulation current of the electrode positioned in the ventricle and issue a VA cycle to determine when a current in the electrode positioned in the atrium must be emitted. At the same time, the electrode positioned in the ventricle then emits in the same way, a VA (constant) delay but compared to the initial cycle will induce a shorter delay between 2 stimulation currents of the electrode positioned in the atrium. : It induces an acceleration of the stimulation frequency of the 2 electrodes gradually without the 2 electrodes communicating with each other directly. The moment when the electrode positioned in the atrium again produces a stimulation current, corresponds to the spontaneous cycle of the patient reduced by the decrement set up by the electrode positioned in the ventricle according to the method defined above. The electrode positioned in the ventricle then stops decrementing and returns to the previous frequency to be able to follow the spontaneous rate of the atrium.The VA delay remains the same and if the electrode positioned in the ventricle again detects a current of stimulation of the the electrode positioned in the atrium, it is deduced that the spontaneous frequency of the atria (or atria) varies downward and the electrode positioned in the ventricle proceeds in an inverse manner to determine what is the new operating frequency which must to be adopted. In the case where neither the electrode positioned in the atrium nor that positioned in the ventricle produce stimulation current, the patient is in spontaneous rhythm leads and each of the electrodes remains in standby mode only (respectively AAIR and WIR according to the international pacemaker nomenclature for the electrode positioned in the atrium and ventricle respectively). The maximum tracking frequency of each of the electrodes is determined by the initial programming. In the case where the patient has a high atrial rate suggestive of atrial fibrillation or atrial fibrillation or focal atrial tachycardia, for example, an atrial rate greater than 180 beats 19 per minute, the electrode positioned in the atrium sends an order to the electrode positioned in the ventricle to stop the atrial rate determination algorithm.This stop signal lasts until the detection by the electrode positioned in the atrium of a stop atrial fibrillation, flutteratrial-or- focal atrial atrial heart failure (that is, a passage of the atrial rate below the threshold frequency determined by programming or any other system such as an endocardial acceleration sensor). At this time, the electrode positioned in the atrium sends a new signal to the electrode positioned in the ventricle to restore the initial operation. Thus, the parameters and the steps for controlling the coordinated operation of two wireless or non-probe electrodes positioned in two different cardiac cavities have been determined with a minimization of the communication currents between the two electrodes. This reduces the energy consumption. between the two elements and allows optimized operation of the stimulation system. The method of controlling the concerted operation between at least two wireless or non-probe stimulation electrodes, one of which is located in one atrium of the heart and the other stimulation electrode is in a ventricle of the heart, is characterized in it comprises at least: a step of use, for each of the implanted electrodes, of a direct means for detecting the electrical activity of each electrode, and a step of using a treatment means of the electrical signal received in the first step in order to differentiate the physiological or spontaneous electrical activity from the artificial or stimulated activity, said comparison of the two activities making it possible to define the atrial frequency, whether it is spontaneous or stimulated with an atrio- precise ventricular to ensure optimum operation of the electrodes without transfer of information between them said operation control method conce It does not use direct communication between the electrodes. The control method according to the invention may be applicable to any configuration of stimulation electrodes, in particular in the case of multiple intraventricular electrodes implanted in the left ventricle or the right or left or right ventricle. In this case it is sufficient to determine which electrode must be the reference electrode from which the decrement will begin. The invention is not limited to the variants that have also been described above but must be considered in its most flexible aspects taking into account the desired functions and technical solutions made comparable to those of the present invention. 21

Claims (5)

REVENDICATIONS1. Device for fixing and removing a muscular stimulation electrode or nervous tissue characterized by an assembly obtained by the combination of a stimulation electrode having a retractable fastening system (5) on command, and a means of mobilization (34) or displacement of the stimulation electrode. 2. Device according to claim 1 characterized in that the mobilization means / displacement of the stimulation electrode is constituted by a steerable catheter on command whose distal end is formed by a pluridigitée clamp whose fingers deviate and move closer to the central axis of the probe to control, the fingers of the clamp to capture the body of the stimulation electrode. 3. Device according to claim 2 characterized in that the spacing or the approximation of the fingers of the pluridigitée gripper is obtained by a rack / pinion system (40,50,48,49) associated in series with gears via a belt (39), the rack / pinion system being activated to order. 4. Device according to claim 2, characterized in that the mobilization / displacement means may be a catheter whose distal end is constituted by a shape-memory glove type object. 5. Device according to claims 2 or 3 characterized in that the mobilization / displacement means comprises a guide function for a rod T1 according to the invention actuating the retractable fastening system of the electrode. 22. Device according to claim 1 characterized in that the fixing system of the stimulation electrode comprises a push button with at least 2 equilibrium positions for out and return to order the fixing elements of the electrode of stimulation in direct contact with the target tissue. 7. Device according to claim 6 characterized in that said push button is constituted by a column of elements rotating in a manner determined according to the invention one or more gears (40, 50,48,49) when an initial push applied to the push button. 8. Device according to any one of the preceding claims, characterized in that the stimulation electrode is constituted in part or in whole by a magnetic or paramagnetic type material. 9. Device according to any one of the preceding claims 1,3,4,5,6,7 or 8 characterized in that it further comprises: a steerable catheter having at its distal end an electromagnet, the catheter allowing a temporary fixation with the body of the implanted electrode to extract. a rod T1 according to the invention activating the push button of the electrode according to the invention. 10. Device according to any one of claims 1,3,4,5,6,7 or 8 characterized in that it further comprises a steerable catheter having a means of biasing its distal end via an electrostatic generator external to the patient's body, the catheter allowing a temporary fixation with the body of the implanted electrode to extract. 23