WO2016001494A2

WO2016001494A2 - Novel device for securing and removing a stimulation electrode

Info

Publication number: WO2016001494A2
Application number: PCT/FR2015/000130
Authority: WO
Inventors: Laurent BERNEMAN
Original assignee: Berneman Laurent
Priority date: 2014-06-30
Filing date: 2015-06-30
Publication date: 2016-01-07
Also published as: FR3022789B1; FR3022789A1; WO2016001494A3

Abstract

The invention relates to a novel device for securing and removing a stimulation electrode in and from muscle tissue, and novel means of securing and removing one or more stimulation electrodes in and from muscle or nerve tissue (including nerves, nerve endings and the tissues associated with the axons or in the central nervous system). The invention also relates to a device using these novel means, and to a complete system for the implantation and explantation or removal of an electrode. The invention also presents a method of controlling the concerted functioning of a plurality of electrodes without direct communication therebetween.

Description

New device for fixing and removing a stimulation electrode

The present invention relates to a novel 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 for fixing and removing a stimulation 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 implantation and explantation or removal of a leadless or wired stimulation electrode. The present invention finally describes a method of Operating

coordinated between several leadless electrodes which limits the energy consumption of the 2 leadless electrodes. The present invention also relates to a method for controlling the concerted operation between at least two leadless stimulation electrodes with or without fixing and withdrawal means for their

implantation or their explantation of the muscular or nervous tissue.

A leadless 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 described in US Pat.

US published US 5,411,535 or US patent application US 2007/088398 or US 2011/0251660.

A stimulation 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 electric current created by the device or externally supplied to the device or else via an energy recovery system.

A pacing probe is defined as an electrical conductor for connecting a pacing electrode to a pacing box.

control generating a transmittable electrical pulse to the pacing electrode when necessary.

Currently, 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 housing containing the energy and all the parameters necessary for the completion of the device spot as well as a stimulation electrode. Both elements can communicate via a stimulation probe or by non-wire means. The assembly constituted by the housing and the stimulation electrode forms a pacemaker (also called Pacemaker) in the case of the 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 box 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-wire means or via a stimulation probe associated with the electrode. A variant of the leadless electrodes is described without a box with autonomous operation isolated from the electrode. There is currently no means or inexpensive energy to operate two leadless electrodes or multiple leadless electrodes in a coordinated manner.

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 a stimulation probe. 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 heart. 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 US5411535 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 an explantation device of a leadless cardiac stimulation electrode consisting of a probe provided with one or more lassos at its distal end clinging to the stimulation electrode. leadless heart 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 electrode leadless. It is described only passive or active screw type means and barbs. In addition, this device necessarily requires a fastening means for lasso specifically dedicated to 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 pacing lead in the epicardial position which may lead to a loss of luck.

(impossibility of benefiting from the therapy) or the operating complications of cardiac surgery (pericardial effusion, infection, hematoma).

Another disadvantage of current devices (wired and wireless) is that they offer no simple and low-risk solution for

repositioning of the electrode when it is implanted (in

particular for more than six months or if it is covered in whole or in part 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 vein

subclavian, the wall of the right atrium ...) and mobilization of the stimulation probe in a thrombosis of the subclavian vein which presents a significant risk during the mobilization or displacement of the stimulation probe for a repositioning or a 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 of implanted equipment and the volume of initial material left in place).

A final disadvantage of leadless electrodes is the need for coordinated operation of two leadless electrodes according to a programming adapted by those skilled in the art. This operation coordinated 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 cavities (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 lead stimulation electrode or a wire stimulation electrode if inadvertently the stimulation electrode remained fixed in the heart following a break between the body of the probe and the stimulation 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, the title of which is

"Self-contained intracardiac implant of leadiess type with detachable fastening element" describes a "leadiess" pacing device consisting of a pedestal implanted in the myocardial wall and not

mobilizable associated with a stimulation electrode "leadiess". It is not described or suggested the possibility of removing the stimulation base, only the electrode is dissociable from its base. It is also not specified the means / devices used to dissociate the electrode from its base. In this patent application, the leadiess stimulation electrode is not functional without the implanted base, hence a total volume of the material to be implanted greater and an increase in the surgical difficulty of setting up such a device by compared to a device that would have the entire fixation system located on the electrode itself.

The present invention aims to solve these problems

stimulation electrode implantation and explantation and more

particularly with regard to lead electrodes.

The present invention also relates to a method of moving a stimulation electrode towards its anchoring end point and its anchoring in the target zone. This method comprises a first step of positioning the electrode in the muscle tissue, said electrode comprising a fixing device. A second step of the method consists in fixing the stimulation device in the muscular tissue by implementing a retractable or foldable fastening device on command consisting of a means comprising components functioning in a manner

coordinated such as blades or solid or hollow rods capable of being fixed on command on the target tissue of the electrode that 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 orientable gripper or a "glove" type gripping object allowing

possibly to mobilize or move the electrode. There is thus a union between the pluridigitic forceps and the electrode when the pluridigitic clamp encloses the stimulating electrode. Consequently, the electrode-clamp 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 fastening means and explantation or removal of a stimulation electrode according to the invention is for example constituted by a stimulation electrode comprising blades, rods or microtubes or retractable nanotubes. The slides, microtubes or nanotubes are formed of metallic materials or not. The blades, rods, microtubes or nanotubes can be preformed (or can have a shape memory) and retractable or foldable on

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 efficiency of fixing 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 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 rods or microtubes or nanotubes) which 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 to retract the slides or rods or microtubes or nanotubes to the inside of 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 muscle stimulation electrode having a retractable fastening means on command, in particular a cardiac drive

having a ferromagnetic material or a material

paramagnetic or an association of materials

ferromagnetic and paramagnetic composition in the composition of said electrode, said electrode having a fixing means and

retractable or collapsible explantation device according to the invention,

a leadless muscle stimulation electrode, in particular a cardiac electrode, said electrode having a means of fixation and

retractable explantation on order or foldable according to

the invention,

an orientable probe comprising an electromagnet type material (SEM) an electrostatic generator means external to the body of the patient making it possible to bring the stimulation electrode into contact with an orientable probe having at its distal end the polarization induced by the electrostatic generator by

via electrical wires from the generator

electrostatic and contained in the probe.

a housing comprising all the parameters necessary for the proper functioning of the electrode and allowing the

communication with a system external to the patient's body for modifying the reference operating parameters of the electrode. The housing is connected to the electrode by wired means or by WiFi

a pluridigitated forceps whose fingers can move away or approach on command (34).

an object of form shape glove with shape memory

The complete system for 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 or nervous stimulator type (including the peripheral nerves and the cranial nerves or the central nervous system), for example cardiac.in an implanted endovascular stimulation probe and more particularly a medical or veterinary device comprising implantation equipment and

explantation of a muscular or nervous stimulation system (including the central nervous system, cranial nerves and the 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 included 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 brought to the optimum point of stimulation. This description is not limiting and on the contrary covers all the variants of the invention or functional equivalent: We will now describe a particular mode of operation of the pluridigitée gripper (FIGS. 9A, B, C, 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 system with two distal wheels) via a belt by wheel torque (belts 1 (39) and (44)

respectively). The 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 so that

characteristic (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 (42) and (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 in order to return it to the neutral position (ie with the fingers of the push button). 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 shaft T1 (26) has at its distal end a gear on all of its faces. In this preferred mode, the rod T1 (26) activates a rack which will allow the deployment of the fastening system by pressing the element B through a device that will be described below. In case of several fastening elements, the rod T1 (26) can set in motion several

racks as long as there are fasteners on the electrode). In another preferred embodiment, the rod T1 is in the central axis of the pluridigitée gripper and will allow to activate a push button (31) common to all the fasteners setting in motion each element C1 (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 example of realization and should be understood as encompassing all

functional equivalents.

It is constituted by a push-button type system (31) associated with a column of elements rotating several gears which will be further detailed allowing ultimately the exit and re-entry

of fastening elements of the electrode on the target tissue (33) at each activation of the pushbutton by external solicitation and on command:

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 E1 (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 element A. there is also at E1 (8) a cleat TA (9) perpendicular to the major axis of A (5).

The second element B (6) is at the end E1 (8) of A (5) .ll 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 E1 (8) a complementary depression TA cleat (9) which prevents B (6) out of A (5) by the end E1 (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 E1 (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 C1 (10), the spring K2 (11) would be stressed and C1 would approach C2 When the external applicator would withdraw, C1 would be pushed to the stop (TA) by the spring K2 that the system It is thus possible to ensure hermeticity of the system with each manipulation of the device.

The third element C (7) consists of two wheels R2 (18) and R3 (21) interconnected by a central rod T2 (19), R2 (18) being the closest to B. R2 and R3 are toothed on each of their face closest to E1 (8) .The rod T2 has a degree of freedom at R3 by allowing a rotation around the axis of T2 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). In addition, the diameter of R2 (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 of R2 on R1 which leads to the rotation of C with respect to B. The degree of rotation of C with respect to B is a function of angulation and height (h1 and h2 respectively) and their width (b1 and b2 respectively) 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 CRs.

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 diameter of the body of R3 is less than that of R2 but has at its branches a diameter equal to or discreetly lower than that of A to allow its setting in rotary motion. The teeth of R3 (29) are located at the ends of the branches of R3. Typically, the R3 teeth are flat or beveled or discretely 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 wedges (CA) alternating with the single 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 therefore the element C) so

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 that 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 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 A).

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 makes it possible to pass only T3. The diameter of K1 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 K1 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 K1 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 allows to multiply by the points of attachment of the electrode on the target tissue. In addition, in a preferred embodiment, numerous variants of the invention can be included without limiting its scope: for example, it is possible to add a tight and fixed or integral film on the element A at the level of E1 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 leadless stimulation electrode covered with fibrosis in association with the device according to the invention:

It is possible to use a steerable probe (S1) routinely used 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 contacting of said probe with the stimulation electrode containing a ferromagnetic or paramagnetic element or both materials.

Another variant according to the invention relates to another means of bringing the stimulation electrode into contact with a probe S2 which is

orientable and similar in nature to the electrophysiological probes marketed (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 S2 probe 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 covered in whole or in part by an electrical insulating element which allows when the probe S2 comes close to the insulated area, to polarize the electrode and to fix or make the electrode and the probe S2 integral.

It is 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 fixation between the probe S1 (or S2) and the electrode is carried out, the probe S1 (or S2) can be used as an internal guide for a sheath sufficiently large to allow to encompass the formed assembly by a stimulation electrode always implanted and the 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 T1 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 retracted, we can thanks to the pluridigitée clip remove

the entire stimulation electrode without leaving at the implantation site any trace of the implanted device

previously.

The 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 leadless electrode.

Body of the pluridigitée forceps (1), finger 1 for fixing the forceps

pluridigitée (2), clamping finger V of the pluridigitée clamp (3), leadless electrode (4), tricuspid valve (53).

Figure 2 A: longitudinal section 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), C1 (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), C1 (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 area 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 E1 (8) under initial pulse of K1 (22).

Figure 4: section perpendicular to the major axis of the fastening element 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 T1.

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 position

"return" 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 leadless stimulation electrode using the pluridigit clamp. Example with 2 fixing elements positioned on the periphery of the electrode.

T1 (26), Support Rod (30), Central Push Button (31), Element B

(6), Element C (7), T3 (24), Body of the stimulating electrode (contains the whole electrode except the fixation system), Target tissue to stimulate (33), Pluridipitous forceps (34) ).

Figure 9B: section perpendicular to the major axis of the electrode

stimulation passing through the central push button (case of the support rod) with 3 fixing elements positioned on 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 electrode

stimulation 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 Y (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, several electrodes with or without a fixing system and means for fixing or removing a leadiess electrode (wireless).

The assembly constitutes a leadiess cardiac stimulation device comprising one or more electrodes making it possible to function optimally with respect to the needs of the patient.

The method for controlling the coordinated operation of at least two lead 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 heart 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 a low amperage of less than 40 milliamps (mA). This electrical activity of the electrode 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 electrical activities

different: one spontaneous and the other artificial in both their duration of emission and their voltage.Cette differentiation is for example carried out using a suitable filter incorporated in the system of the 2 electrodes or any other treatment of 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 an electrode

leadiess. 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.

By way of illustration, the case of two lead electrodes is described, one electrode of which is positioned in an atrium (right or left) and the other leads in a ventricle (right or left). The method is applicable for a multitude of electrodes operating in a

coordinate. The leadless 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 (DAVS) to define when the electrode positioned in the ventricle must emit a current of

stimulation. The electrode positioned in the ventricle then determines a ventricular-atrial (VA) delay which corresponds to the moment when the electrode positioned in the atrium should emit a stimulation current again. If the electrode placed in the atrium (or atrium) emits a current of stimulation again, we start again on the same

operations. If no pacing current is detected by the ventricular electrode, the ventricular electrode will consider that an activity

electrical spontaneous will have been detected by the electrode positioned in the atrium and will have caused its inhibition. The electrode positioned in the ventricle will then reduce its operating cycle (i.e. increase its discharge frequency) according to a set parameter, for example 1 beat per minute and trigger ventricular pacing earlier than its programming. does not provide for it. The electrode positioned in the atrium will then sense the stimulation current of the electrode positioned in the ventricle and emit a VA cycle to determine when a current in the electrode positioned in the atrium is to 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 ceases the decrement 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 electrode positioned in the atrium, it is deduced that the spontaneous frequency of the atria (or auricles) varies downward and the electrode positioned in the ventricle proceeds in an inverse manner to determine what is the new operating frequency which must be adopted.

In the case where neither the electrode positioned in the atrium nor that

positioned in the ventricle do not 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 nomenclature pacemakers for the electrode

positioned in the atrium and ventricle respectively).

The maximum frequency of tracking of each of the electrodes is

determined by the initial programming.

If the patient has a high atrial rate suggestive of atrial fibrillation or atrial flutter or focal atrial tachycardia, for example, an atrial rate greater than 180 beats 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.Atrial flutter or focal atrial tachycardia (that is, a passage of the atrium frequency below the

threshold frequency determined by programming or any other system such as an endocardial acceleration sensor). At this moment, 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 of control of the coordinated operation of two lead electrodes positioned in two different cardiac cavities with a minimization of the communication currents between the two electrodes have been determined. This makes it possible to reduce 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 lead stimulation electrodes, one of which is located in an atrium of the heart and the other stimulating electrode is located in a ventricle of the heart.is characterized in that has at least:

a step of use, for each of the electrodes

implemented, a direct means of detecting the activity

each electrode, and

a step of using an electrical signal processing means 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. it is spontaneous or stimulated with a precise atrio-ventricular delay to ensure optimal functioning of the electrodes without transfer of information between them said concerted operation control method does not use direct communication between the electrodes.

The control method according to the invention may be applicable to any configuration of stimulation electrodes, particularly in the case of multiple intraventricular electrodes implanted in the left ventricle or the right or left or right intraatrial ventricle. In this case, it is sufficient to determine which electrode must be the reference electrode from which will start the decrement.

The invention is not limited to the variants which have also been described above but must be considered in its most

modular in taking into account the desired functions and technical solutions made comparable to those of the present invention.

Claims

1. Device for fixing and removing a muscular stimulation electrode or nervous tissue characterized by a set obtained by the combination of a stimulation electrode

having a retractable fastening system on command, a means of mobilization or displacement of the stimulation electrode.

2. Device according to claim 1 wherein the mobilization means / displacement of the stimulation electrode is constituted by a steerable catheter on command whose distal end is formed by a pluridigitée gripper whose fingers deviate and are closer to the central axis of the probe to order, 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 multi-purpose gripper is obtained by a rack / pinion system associated in series with gears via a belt according to the invention. The rack and pinion system is activated to order.

4. Device according to claim 2, wherein the gripping 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 according to which the

gripping means comprises a guide function for a rod T1 according to the invention actuating the retractable fastening system of the electrode.

6. The assembly of claim 1 characterized in that the means for fixing the stimulation electrode comprises a push button with at least 2 equilibrium positions.

allowing the fastening elements of the stimulation electrode to come out and return to control in direct contact with the target tissue.

7. retractable fastening system according to one of claims 1, 2,5 or 6 characterized in that it belongs to the stimulation electrode and is constituted by a push button type system for the output and the retraction of the electrode fixing elements by having at least 2 equilibrium positions successively attained at each external activation of the system, said pushbutton being characterized in that it is constituted by a column of element rotating in rotation; determined according to the invention one or more gears during the initial thrust applied to the push button.

8. Assembly according to one of claims 1, 6 or 7 characterized in that the stimulation electrode is constituted in part or in whole by a magnetic type material or

paramagnetic.

9. Device for removing an implanted stimulation electrode

according to one of claims 1, 3,4,5,6,7 or 8, characterized in that it consists of

An implanted stimulation electrode having a retractable attachment system.

an orientable catheter having at its distal end an electromagnet. The catheter for temporary fixation with the body of the implanted electrode to be extracted. -a detachable gripping means of the electrode according to claims 3,4 or 5 pluridigit gripper type or shape-memory glove type.

a rod T1 according to the invention activating the push button of the electrode according to the invention.

10. Device for removing an implanted stimulation electrode according to one of claims 1, 3,4,5,6,7 or 8, characterized in that it consists of:

An implanted stimulation electrode having a retractable fastening system according to the invention.

an orientable catheter having a means of biasing its distal end via an electrostatic generator external to the body of the patient. Catheter for fixation

temporary with the body of the implanted electrode to extract, -a detachable gripping means of the electrode according to claims 3,4 or 5 pluridigitée clip type or shape-memory glove.

A method of controlling the concerted operation between at least two leadless stimulation electrodes, one of the electrodes of which is located in one atrium of the heart and the other stimulation electrode, is located in a ventricle of the heart, characterized in that has at least

a step of use, for each of the electrodes

implemented, a direct means of detecting the activity

each electrode, and

a step of using an electrical signal processing means 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. it is spontaneous or stimulated with a precise atrio-ventricular delay to ensure optimal functioning of the electrodes without transfer

information between them and

said concerted operation control method does not use direct communication between the electrodes.