LBB defibrillation probe

Abstract

The object of the present invention relates to a cardiac defibrillation lead comprising a lead body, an anode, and a distal tip implantable in the upper septum of the heart, characterized in that said cardiac lead is configured to fit in a loop in the apical region of the heart. Abstract figure: Figure 2

Description

Title of the invention: LBB defibrillation probe

[0001] The object of the present invention relates to a cardiac defibrillation lead comprising a lead body, an anode and a distal end implantable in the upper septum of the heart, characterized in that said cardiac lead is configured to fit in a loop in the apical region of the heart. EARLIER ART

[0002] Historically, right ventricular (RV) pacing has been used for the treatment of patients with heart failure via pacemaker and / or defibrillator. However, in some cases, RV pacing has been shown to induce electrical and mechanical dyssynchrony.

[0003] One of the solutions adopted in the art in order to overcome this technical problem is the so-called "LBBAP" technique (for "left bundle branch area pacing" in English) developed to directly capture the conduction of the left branch by penetrating the ventricular septum.

[0004] The location of the left bundle branch is generally 1 to 1.5 cm distal to the area of ​​the HIS along the septal wall in the heart. When the pacing lead is placed, it is typically screwed into the septum on the right ventricular side. This procedure is performed by a practitioner (such as a surgeon or electrophysiologist) and carries the risk of septal perforation.

[0005] Thus, LBB stimulation is clinically feasible in patients with heart failure (HF) with an LBB lead and / or in patients requiring cardiac resynchronization therapy (CRT), via, for example, treatment including defibrillation of the heart using an LBB lead.

[0006] Patent documents EP1830920, US11911166B2, and EP3697493 illustrate the state of the art concerning the so-called "LBB" technique.

[0007] However, in the LBB position, the tip of the lead (also called the "tip" of the lead) is implanted in the upper septum of the heart (versus the apex or lower septum for conventional leads intended to treat bradycardia and / or tachycardia). Furthermore, LBB leads have a significantly smaller diameter compared to conventional leads used to treat tachycardia, in particular to maintain good puncture capacity and to limit the size of the insertion catheter.

[0008] In particular, when present, the defibrillation electrode (also called a "coil") is sized according to the diameter of the lead (typically 4.5 F for an LBB lead versus 8-9 F more commonly; F representing the "French" unit equal to one-third of a millimeter). This requires increasing the diameter by approximately 50%. length of said electrode in order to preserve a surface area equivalent to a “traditional” electrode and limit the current density to preserve cardiac tissue during the administration of defibrillation therapy.

[0009] A conventional defibrillation electrode intended to be inserted into the right ventricle of the heart under the conditions specific to LBB thus leads to the exposure of most of its active surface in the right atrium, resulting in new difficulties: - the creation of a significant deviation of the firing axis towards the housing containing the electronics, raising the question of the effectiveness of the therapy delivered (particularly with regard to the positioning in a classic treatment of tachycardia); and - a possible overlap of the position of the defibrillation electrode in the tricuspid valve with the risk of mutual damage or increased difficulty of extraction, if applicable, due to adhesion to the leaflets of the heart.

[0010] Other known important elements are also to be considered, in particular, the elements leading to difficulties in extracting defibrillation probes.

[0011] The most critical adhesion points of such probes are located at the level of the so-called "SVC" defibrillation electrode (SVC stands for "superior vena cava" in English, or "superior vena cava" in French), linked in particular to: - at the mechanical support point of the probe body on the external wall of the superior vena cava (inflection point of the overall trajectory of the probe in the access vein), - to the cyclic mechanical thrust on this support area due to the heartbeat, - to the development of fibrosis promoted by micromovements relative to the defibrillation electrode in relation to the surrounding tissue, and / or - to the thinness of the superior vena cava.

[0012] In addition, various technologies have been developed to protect defibrillation electrodes, for example by adding a silicone underlayer (called "back filling") to limit the formation of fibrosis between the wires of the defibrillation electrode. While this technology is recognized as effective, it has the disadvantage of significantly stiffening the lead body at the defibrillation electrodes.

[0013] Thus, the object of the present invention aims to solve these problems by proposing a new probe, adapted to a new implantation scheme for it in the heart of a patient. Summary of the invention

[0014] The object of the present invention relates to a cardiac defibrillation probe comprising a probe body, an anode and a distal end implantable in the upper septum of the heart, characterized in that said cardiac probe is configured to fit in a loop in the apical region of the heart.

[0015] It has indeed been discovered that by applying such a loop to the probe in the apical region of the heart, the end of the probe is optimally positioned with respect to the upper septum, i.e. orthogonally or almost orthogonally to the upper septum, avoiding unwanted interactions with the tricuspid valve.

[0016] In one embodiment, the probe supports two functions, therapy delivery (commonly referred to as "pacing" in the art) and detection (commonly referred to as "sensing" in the art).

[0017] In one embodiment, the probe takes charge of the delivery of therapy (commonly referred to as "pacing" in the art).

[0018] In one embodiment, the probe takes care of the detection (commonly referred to as "sensing" in the art).

[0019] By "implantable distal end", it is understood in the context of the present invention that the distal end is configured (or adapted) to be implanted.

[0020] In the context of the present invention, the term "loop" refers to a probe describing a U-shape, the acute angle of curvature of which (i.e., the angle formed by the projection of the straight portions of the U at their intersection) is advantageously less than or equal to 45°, preferably less than or equal to 30°, less than or equal to 20°, less than or equal to 15°, less than or equal to 10°, less than or equal to 5°, or equal to 0°, i.e., the straight portions of the U are parallel to each other. In one embodiment, the angle formed by the projection of the straight portions of the U at their intersection on the side of the continuous curvature of the U is advantageously less than or equal to 45°, preferably less than or equal to 30°, less than or equal to 20°, less than or equal to 15°, less than or equal to 10°, or less than or equal to 5°.In one embodiment, the angle formed by the projection of the straight portions of the U at their intersection with the open side of the U is advantageously less than or equal to 45°, preferably less than or equal to 30°, less than or equal to 20°, less than or equal to 15°, less than or equal to 10°, or less than or equal to 5°. In one embodiment, the loop is closed, or in other words, by projection onto a plane the probe describes an O of typically oval or circular shape.

[0021] As is known in the art, the interventricular septum is the wall separating the two cardiac ventricles. Together with the interatrial septum, which extends from it superiorly, it constitutes the entire cardiac septum, namely the entire wall separating the right heart from the left heart. Thus, the term "upper septum of the heart" refers to the upper region of the interventricular septum, which includes (or consists of) the region of the septum adjacent to the leaflets of the tricuspid and sigmoid (pulmonary) valves, advantageously including the trunk of the bundle of His.

[0022] In the context of the present invention, the "apical region of the heart" refers to the area extending from the papillary muscles to the end of the cardiac chamber. The apex of the heart is located at the lower end of the heart when it is positioned in the thoracic cavity of a person standing or sitting. The apex of the heart is therefore comprised of the left ventricle and the right ventricle. Thus, it is recognized in the prior art that the apex of the heart is defined by the apex of the left ventricle (LV) and the apex of the right ventricle (RV). This represents a very clearly defined region for practitioners. Indeed, certain pathologies affect the apex of the heart, such as myocarditis, cardiomyopathy, and heart attack. The tissues of the apex are therefore clearly defined and delimited: the apex is the myocardium extending beyond the end of the myocardial cavity.For example, in short-axis imaging, the basal region is considered to end when the myocardium no longer extends through 360°. The apical region of the heart (the area from the papillary muscles to the end of the cardiac chamber) therefore includes the apex, which is a physiologically defined area. Thus, preferably in the context of the present invention, the apical region is the apex of the heart. Such an arrangement will allow optimal use of the volume provided by the right ventricle for inserting a loop according to the present invention. DETAILED DESCRIPTION

[0023] Preferably, the probe body thus has a length suitable for its inscription along a loop along the apical region of the heart.

[0024] Such a loop is easily made by adapting, for example, the length of the probe. For example, by increasing the length of the probe (compared to what is currently done in the art), it is easy to make a loop according to the present invention.

[0025] In the context of the present invention, "along the entire apical region of the heart" means that the probe runs parallel to or follows the wall of the apical region of the heart (i.e., along a continuous line projected onto the apical region of the heart) and / or is in contact with the wall of the apical region of the heart. The distance between the probe and the wall of the apical region of the heart is preferably constant or approximately constant when the cardiac muscles of the apical region of the heart are at rest.

[0026] Preferably, the length of the probe is adjusted to limit contact between the probe and cardiac tissues, particularly in the apical region of the heart. Indeed, by minimizing contact, the risk of fibrosis development is reduced.

[0027] Another way of expressing the object of the present invention is to refer to the length of the probe so that this probe length is adjusted so that at least a portion of said probe, in particular a portion of the probe body, is in the apical region of the heart (i.e. in the lower third of the right ventricle), preferably close to the apex (i.e. in the lower quarter of the right ventricle).

[0028] For example, in an average-sized adult heart, in the context of the present invention, a possible embodiment according to the present invention is a probe of sufficient length so that a portion of the probe body is placed at a distance less than or equal to 5 cm, preferably less than or equal to 4 cm, less than or equal to 3 cm, less than or equal to 2 cm, or even less than or equal to 1 cm from the apex of that person's heart.

[0029] Furthermore, the probe body has a flexibility adapted to positioning said cardiac probe in at least a portion of the apical region of the heart. Thus, by varying the flexibility of the probe body, it will be possible to give it a shape specifically adapted to the morphological characteristics of the patient's heart (which can be analyzed before implantation).

[0030] Preferably, the probe body has a flexibility adapted to a positioning of said cardiac probe so as to conform to at least a portion of the contour of the cardiac cavity from the anchoring point on the septum to the free wall, preferably passing through the apex.

[0031] Advantageously, the probe includes at least one defibrillation electrode configured to be inserted into the right ventricle of the heart.

[0032] Preferably, the diameter of the probes usable according to the present invention varies between 1 mm and 4 mm, preferably between 1.2 mm and 3 mm, more preferably between 1.3 and 2 mm, even more preferably between 1.4 and 1.7 mm, for example 1.5 mm ± 0.5 mm.

[0033] In a particular embodiment, the probe according to the present invention comprises different portions of different diameters.

[0034] Advantageously, the probe according to the present invention comprises at least two portions of different diameters.

[0035] In particular, the probe according to the present invention comprises at least two portions of different diameters, at least one of said at least two portions being a portion of probe body.

[0036] More particularly, the probe according to the present invention comprises at least two portions of different diameters, said at least two portions being portions of probe body.

[0037] For example, the probe according to the present invention comprises at least one portion of the probe body with a diameter different from at least one portion of the probe body located distally on said probe. Preferably, the probe according to the present invention comprises at least one portion of the probe body with a diameter greater than at least one portion of the probe body located distally on said probe. More preferably, the probe according to the present invention comprises at least one portion of a defibrillation electrode with a diameter greater than at least one portion of the probe body located distally on said probe.

[0038] In particular, the probe according to the present invention comprises at least one portion of the probe body with a diameter different from that of at least one distal portion of said probe. Preferably, the probe according to the present invention comprises at least one portion of the probe body with a diameter greater than that of at least one distal portion of said probe. More preferably, the probe according to the present invention comprises at least one portion of a defibrillation electrode with a diameter greater than that of at least one distal portion of said probe.

[0039] For example, the probe according to the present invention comprises at least one portion of the probe body with a diameter different from at least one portion located between the distal end of said probe and a defibrillation electrode placed on said probe. Preferably, the probe according to the present invention comprises at least one portion of the probe body with a diameter different from at least one portion located between the distal end of said probe and a defibrillation electrode placed on said probe. More preferably, the probe according to the present invention comprises at least one portion of the probe body with a diameter greater than at least one portion located between the distal end of said probe and a defibrillation electrode placed on said probe.Even more preferably, the probe according to the present invention comprises at least a portion of a defibrillation electrode with a diameter greater than at least a portion of the probe body included between the distal end of said probe and said defibrillation electrode.

[0040] More advantageously, the probe according to the present invention comprises at least a portion of probe body with a diameter greater than a distal portion of probe body on said probe.

[0041] There are several advantages to having different diameters. In particular, different diameters of the probe body make it possible to limit the number of defibrillation electrodes, for example to only one, as well as to limit the risks of fibrotic adhesion while benefiting from the advantages of the distal portion of the probe, in particular the flexibility of this distal portion.

[0042] Thus, an embodiment according to the present invention comprises a distal portion with a diameter between approximately 1.33 mm and approximately 1.84 mm (i.e., between 4 and 5.5 French), preferably of approximately 1.5 mm (i.e., 4.5 French), and at least one defibrillation electrode with a diameter between approximately 2.33 mm and approximately 3.34 mm (i.e., between 7 and 9 French), preferably of approximately 2.67 mm (i.e., 8 French). Thus, with such a defibrillation electrode diameter, the delivery surface area of ​​the defibrillation treatment allows for maintaining a standard defibrillation surface area over a standard length.

[0043] In one embodiment, an increase in the diameter of the defibrillation electrode (for example between approximately 2.83 and 4.0 mm (i.e. between 8.5 and 12 French)), its length can be reduced compared to conventional values.

[0044] Furthermore, the practitioner will adapt the implantation tools to these probes. For example, catheters with larger diameters than those typically used for LBB placement, and with adapted mechanical characteristics (e.g., increased rigidity), will be usable for implanting these probes. As an example, catheters with a diameter of approximately 3.33 mm to approximately 3.67 mm (i.e., between 10 and 11 French) are usable for a probe with a maximum diameter of approximately 2.67 mm (i.e., 8 French).

[0045] [Rev. 4] Advantageously, the cardiac probe comprises at least one defibrillation electrode configured to be inserted into the right ventricle of the heart, said at least one defibrillation electrode configured to be inserted into the right ventricle of the heart is split into at least two segments, one referred to as the proximal segment of the right ventricle (RVP segment) and the other referred to as the distal segment of the right ventricle (RVD segment), the latter being placed distally to the RVP segment on said cardiac probe.

[0046] Several advantages result from segmenting the defibrillation electrode. For example, it is possible to fine-tune the lead's flexibility by segmenting the electrodes, whose flexibilities are generally less pronounced than those of the lead body, for instance. Furthermore, it is possible to adjust the treatment administered with multiple electrodes: it is possible to select the electrodes with the best placement within the heart chamber for precise and patient-specific delivery.

[0047] Preferably, at least one RVD segment is positioned on the cardiac lead so as to be closer to the cardiac septum than at least one RVP segment (i.e., once the lead is implanted in the heart).

[0048] Preferably, at least one RVP segment is positioned on the cardiac probe so as to be closer to the ventricular free wall than at least one RVD segment (i.e., once the probe is implanted in the heart).

[0049] In a particular embodiment, the different segments of the defibrillation electrode are connected to the same electrical potential.

[0050] Preferably, segments RVP and RVD are connected to the same electrical potential. Connecting the different segments (in particular RVP and RVD) to the same electrical potential ensures that the delivery of the electrical current is homogeneous between the segments (in particular RVP and RVD).

[0051] In a particular embodiment, the different segments of the defibrillation electrode have similar, or even identical, contact surfaces with the biological medium. More specifically, at least the RVP segment and the RVD segment have similar, or even identical, contact surfaces with the biological medium. Indeed, identical or similar contact surfaces between the different segments (in particular RVP and RVD) with the biological medium also improve the homogeneity of the administered current.

[0052] By "similar" it is understood in the context of the present invention that the variations do not exceed 10% of the largest measurement value of the objects considered.

[0053] Preferably, said probe comprises a portion having greater flexibility than any of the different segments of the defibrillation electrode, preferably with a stiffness gradient.

[0054] More particularly, said cardiac probe includes a portion having greater flexibility than either of the two segments RVP and RVD, preferably with a stiffness gradient.

[0055] By “stiffness gradient”, in the context of the present invention, is understood a rate of change of stiffness in a given portion of material.

[0056] One of the advantages of introducing a transition section with a stiffness gradient between two sections with different flexibilities is to prevent weakening between these two sections that could lead to breakage. Indeed, a stiffness gradient oriented so that the end of the transition section with the greatest stiffness is adjacent to a probe section with lower flexibility (such as a defibrillation electrode) allows for a flexibility / stiffness transition distributed over a distance that minimizes stresses and mechanical forces at fixed points. The intermediate section with a stiffness gradient thus plays a role in moderating the mechanical stresses and forces between the two sections.

[0057] In a particular embodiment, the RVP and RVD segments are separated by a portion of the probe body without a defibrillation electrode.

[0058] In this configuration, the probe is arranged optimally to exhibit the best flexibility over its entire length.

[0059] In one embodiment, the RVP and RVD segments are placed on the probe in a manner dedicated to the morphology (particularly cardiac) of one or more particular patients.

[0060] In a particular embodiment, said portion of the probe body (separating the RVP and RVD segments and lacking a defibrillation electrode) comprises silicone and / or has a diameter adapted to reduce the thickness of an external insulator, such as polyurethane.

[0061] Silicone is an alternative material to polyurethane.

[0062] Silicone may also be of interest in the case, for example, of patients with particular sensitivities (such as allergies) to polyurethane, and vice versa.

[0063] Furthermore, the use of certain silicones is advantageous in terms of flexibility.

[0064] Advantageously, a complementary fastening means, for example a beard-type fastening means, is placed between the RVP and RVD segments, preferably on a portion of the probe body.

[0065] Thus, it is possible to fix the probe in several locations within the cardiac cavity. This is advantageous, in particular, to avoid the generation of fibrosis linked to recurrent displacements that induce friction on the tissues of a foreign body within the cardiac cavity.

[0066] Advantageously, the distal end implantable in the upper septum of the heart is not in direct contact with the RVD segment, for example the RVD segment and said distal end implantable in the upper septum of the heart are separated by a portion of the probe body.

[0067] Thus, the portion of the probe body separating the implantable distal end and the RVD segment relieves this distal end of mechanical stresses that could induce unintended pressure on the septum. Therefore, the risk of septal perforation is reduced.

[0068] Advantageously, the RVD segment is placed at a distance of between 10 and 55 mm from the distal end of the cardiac probe.

[0069] In other words, the distal end of the probe, for example where there is a fixing screw intended to be implanted in cardiac tissue, is at a distance of between 10 and 55 mm from the RVD segment.

[0070] It has indeed been determined that such a distance is optimum for the probe to be positioned orthogonally to the septum, thus freeing it from mechanical stresses that could induce unwanted pressure on the septum. This reduces the risk of septal perforation.

[0071] By "placed at a distance of between 10 and 55 mm", it is understood in the context of the present invention that the distal end of the RVD segment is placed at a distance of between 10 and 55 mm from the distal end of the lead. Where the distal end of the lead includes a fixation screw intended to be implanted in cardiac tissue, "the end of the lead" is to be distinguished from the fixation screw which is added, implanted, fixed, etc., at that location.

[0072] Preferably, an RVP segment is placed at a distance of between 11 and 50 mm from an RVD segment, more preferably between 12 and 50 mm from an RVD segment, between 13 and 40 mm from an RVD segment, between 15 and 35 mm from an RVD segment, or between 20 and 30 mm from an RVD segment, even more preferably at 25 mm ± 3 mm from an RVD segment.

[0073] Typically, the fixing screw acts as a cathode.

[0074] Typically, the anode is positioned at a distance less than or equal to 30 mm from the cathode, for example less than or equal to 25 mm from the cathode, less than or equal to 20 mm from the cathode, less than or equal to 15 mm from the cathode, less than or equal to 10 mm from the cathode.

[0075] For example, the anode is positioned at a distance of between 2 and 35 mm from the cathode, preferably between 3 and 30 mm, such as between 4 and 20 mm, between 5 and 15 mm, or between 6 and 12 mm.

[0076] Preferably, the anode is positioned at a distance of 9 mm ± 3 mm from the cathode.

[0077] In a particular embodiment, the cardiac probe according to the present invention has an integrated bipolar configuration. "Integrated bipolar" means that at least one of the defibrillation electrodes (in particular the RVD segment and / or the RVP segment) is configured to have a dual function, for example, sensing and, if necessary, defibrillation. The advantage is to limit the number of conductive wires in the probe and to optimize the use of the conductive surfaces of the cardiac probe.

[0078] Thus, advantageously, the RVD segment is at least 10mm away from the anode, preferably 25mm ± 5mm from the anode.

[0079] In one embodiment, the RVD segment is at least 15 mm away from the anode, for example at least 20 mm from the anode, at least 25 mm from the anode, at least 30 mm from the anode or at least 35 mm from the anode.

[0080] Preferably, the RVD segment is located between 15 and 35 mm from the anode, more preferably between 20 and 30 mm from the anode, even more preferably at 25 mm ± 3 mm from the anode.

[0081] In a particular embodiment, the flexibility of the portion of the probe body placed between the RVD segment and the distal end implantable in the upper septum of the heart is greater than the flexibility of another portion of the probe body in a proximal position relative to the RVP segment, in particular greater than the flexibility of the portion of the probe body placed between the RVP and RVD segments.

[0082] Thus, the superior flexibility of the portion of the probe body located between the RVD segment and the distal end implantable in the upper septum of the heart allows this distal end to be freed from mechanical constraints that could induce unwanted pressure on the septum. Therefore, the risk of septal perforation is reduced. In addition, a lower flexibility of the probe body placed between the RVP and RVD segments and / or greater flexibility than a portion of the probe body in a proximal position relative to the RVP segment, helps to maintain the probe in a loop shape in the apical region of the heart.

[0083] Advantageously, the cumulative linear length of the RVP and RVD segments is between 60 and 120 mm.

[0084] Thus, the cumulative length of the RVP and RVD segments, between 60 and 120 mm, allows for optimized current delivery in the context of cardiac defibrillation.

[0085] Preferably, the cumulative linear length of the RVP and RVD segments is between 70 and 110 mm, more preferably between 80 and 100 mm, even more preferably 90 mm ± 5 mm.

[0086] In a particular embodiment, the RVP and RVD segments are arranged on the cardiac probe so as to be positioned in anterior and posterior commissures of the right ventricle cavity of the heart, once the cardiac probe is implanted.

[0087] Thus, in a particular embodiment, the cumulative linear length of the RVP (8) and RVD (9) segments is between 60 and 120 mm and preferably the RVP (8) and RVD (9) segments are arranged on the cardiac probe (1) so as to be positioned in anterior and posterior commissures of the right ventricle cavity of the heart once the cardiac probe (1) is implanted.

[0088] In this way, the probe is kept in place, which prevents it from movements that are detrimental to its operation, or even generate intracardiac injury(ies) (in particular by avoiding whip-like movements).

[0089] The object of the present invention also relates to a method of manufacturing the probe described herein.

[0090] In particular, the object of the present invention relates to a method of manufacturing a probe as described herein, comprising a step of preforming the probe (i.e. before its implantation).

[0091] Preferably, the preforming step is carried out during the manufacture of the probe.

[0092] Alternatively, the preforming step can be performed during implantation. The cardiac lead is then adapted for such a preforming step.

[0093] In a particular embodiment, the preforming step is carried out during the manufacture of the probe, and the probe is adapted where appropriate to an additional preforming step feasible (for example by the practitioner) during implantation.

[0094] In one embodiment, the probe preforming step consists of preforming at least a portion of the probe into a U shape, for example a portion of the probe body and / or an active element of the probe, such as an electrode.

[0095] In one embodiment, preforming includes the insertion of a structure having a particular shape, or the deformation of a portion of the probe, for example by the use of a mold and / or a heating means.

[0096] The object of the present invention also relates to the placement of a cardiac probe according to the present invention during its implantation.

[0097] For example, the lead is first attached (by screwing) to the septum of the heart. Then, the lead is advanced into the ventricle so that it forms a loop (or a U-shape as explained above) in the apical region of the heart. Finally, the lead is connected to an implantable electrical device, such as an implantable defibrillator and / or pacemaker.

[0098] Indeed, in one embodiment, the cardiac probe according to the present invention is configured to be compatible with a mandrel.

[0099] The mandrel has the advantage of being able to help the placement of the probe by temporarily stiffening it during the placement process.

[0100] Indeed, in one embodiment, the cardiac probe according to the present invention is configured to be compatible with a placement catheter.

[0101] The catheter is a complementary tool to the mandrel to help the placement of the probe by using the rigidity provided by said catheter.

[0102] These means of placement are compatible with the probes commonly used in the art, as well as the cardiac probe according to the present invention.

[0103] Thus, in a particular embodiment, the cardiac probe according to the present invention is a multi-wire coaxial cardiac probe, or a multi-lumen type cardiac probe equipped with micro-cables.

[0104] Such a probe makes it possible to increase the possibilities of applications, such as the insertion of means for administering or detecting current(s), or for facilitating implantation.

[0105] Preferably, the multi-wire coaxial cardiac probe includes at least one insulated line configured for high voltage transmission and delivery.

[0106] For the purposes of this invention, "high voltage" means a current with an impedance greater than or equal to 1 ohm, preferably greater than or equal to 2 ohms, more preferably greater than or equal to 3 ohms.

[0107] More specifically in the context according to the present invention, a high voltage is between 1 and 10 ohms, more preferably between 2 and 5 ohms, even more preferably between 2.5 and 4 ohms, such as 3 ohms ± 0.5 ohm. FIGURES

[0108] It should be noted that these figures are merely illustrations of the present invention, which is not limited solely to these embodiments described.

[0109] [Fig.1] Fig.1 represents a side view of the different portions of a probe according to the present invention.

[0110] [Fig.2] Fig.2 represents a three-dimensional view of a probe according to the present invention inserted into a heart seen from the lower right side, opposite the right ventricle.

[0111] [Fig.3] Fig.3 represents a three-dimensional view of a probe according to the present invention inserted into a heart seen from the rear, opposite the right ventricle.

[0112] [Fig.4] The [Fig.4] represents a comparative three-dimensional cross-sectional view of three probes according to the present invention having several openings used for the passage of cables, chuck(s), etc.

[0113] Below is the detailed description of the figures.

[0114] Figure 1 shows the different active portions A, B, C, and D of a lead 1 according to the present invention. The first portion, referred to as "A" in Figure 1, represents the proximal portion of the lead. This first portion A comprises, as shown in Figure 1, at its proximal end, connection means 20 to the various active elements of the lead (e.g., defibrillation electrode(s), anode(s), cathode(s), etc.). The first portion A further comprises a lead body 2 as shown in Figure 1. This lead body 2 provides the connection between the first portion A and the second portion B, which comprises a first segment of a defibrillation electrode divided into two segments: the proximal right ventricular (PRV) segment 8. The second portion B further comprises a first lead body portion 10 located distal to the PRV segment 8.This first portion 10 of the lead body allows connection between the second portion B and the third portion C, which comprises a second segment of a defibrillation electrode divided into two segments: the distal right ventricle (RVD) segment 9. The third portion C further comprises a second portion 11 of the lead body located distal to the RVD segment 9. This second portion 11 of the lead body allows connection between the second portion B and the third portion C, which comprises an anode 3 and a cathode 19. In [Fig. 1], the cathode 19 is located at the distal end 4 of the lead 1 and has a screw-like shape to facilitate its insertion into the cardiac septum. In one embodiment, the cathode 19 is retractable / deployable. In another embodiment, the cathode 19 is fixed. In [Fig. 1], the connecting means 20 are linked one by one to the various active elements of the lead, namely the proximal segment. of the right ventricle (RVP) 8, the distal segment of the right ventricle (RVD) 9, the anode 3 and the cathode 19.

[0115] Figure 2 shows a patient's heart into which a probe is implanted cardiac lead 1 according to the present invention. The heart is viewed from the lower right side, opposite the right ventricle (which is seen in cross-section). The cardiac lead 1 comprises a lead body 2, as well as a defibrillation electrode divided into two segments, one called the proximal right ventricle segment RVP 8 and the other called the distal right ventricle segment RVD 9.

[0116] In [Fig. 2], the cardiac lead 1 is positioned so that its distal end 4 is implanted in the upper septum 5 of the heart. To achieve this, the cardiac lead 1 is configured to form a loop 6 in the apical region 7 of the heart. A portion 10 of the lead body positioned between the RVP segment 8 and the RVD segment 9 facilitates this loop-shaped configuration of the cardiac lead 1.

[0117] The cardiac probe 1 shown in [Fig.2] further has a portion 11 of flexible probe body placed between the RVD segment and the distal end 4, thus facilitating the implantation of this distal end 4 orthogonally to the high septum 5.

[0118] Figure 3 also shows a heart in which an implanted cardiac probe 1 according to the present invention. The heart is viewed from the rear, opposite the right ventricle. In the same way as in [Fig. 2], the cardiac probe 1 comprises a probe body 2, as well as a defibrillation electrode divided into two segments, one called the proximal right ventricle segment RVP 8 and the other called the distal right ventricle segment RVD 9.

[0119] As in [Fig. 2], in [Fig. 3] the cardiac lead 1 is positioned so that its distal end 4 is implanted in the upper septum 5 of the heart. The cardiac lead 1 is therefore also shown here in such a way that the cardiac lead 1 is configured to form a loop 6 in the apical region 7 of the heart. Here too, a portion 10 of the lead body positioned between the RVP segment 8 and the RVD segment 9 facilitates this loop-shaped configuration of the cardiac lead 1.

[0120] The cardiac probe 1 shown in [Fig.3] has, in the same way as in [Fig.2], a portion 11 of flexible probe body placed between the RVD segment and the distal end 4, thus facilitating the implantation of this distal end 4 orthogonally to the high septum 5.

[0121] Figure 4 shows three-dimensional cross-sectional views of three different cardiac probes 1 that can be used in the context of the present invention. The first cardiac probe 12 (currently known as the "Sprint Quattro Madel 6935MTM") on the left has a diameter of 8.6 F (F for French; 1F = 0.15). 1 / 3 of a millimeter). The second cardiac lead 13 (currently known as "LEADR ICD LeadTM") in the center has a diameter of 4.7 F (French). The third cardiac lead 14 (currently known as "SelectSecure Model 3830TM") on the right has a diameter of 4.1 F (French). All three cardiac leads (12, 13, 14) have an insulating polyurethane surface coating 15. All three cardiac leads (12, 13, 14) each include a low-voltage helical electrode conductor 16. Electrodes 12 and 13 each include a high-voltage defibrillation conductor 17. Electrodes 12 and 13 each include a low-voltage ring electrode conductor 18.

Claims

Demands

1. A cardiac defibrillation lead (1) comprising a lead body (2), an anode (3) and a distal end (4) implantable in the upper septum (5) of the heart, characterized in that said cardiac lead (1) is configured to fit in a loop (6) in the apical region (7) of the heart.

2. Cardiac lead (1) according to claim 1, characterized in that the cardiac lead (1) comprises at least one defibrillation electrode configured to be inserted into the right ventricle of the heart, said at least one defibrillation electrode configured to be inserted into the right ventricle of the heart is split into at least two segments, one referred to as the proximal segment of the right ventricle (segment RVP (8)) and the other referred to as the distal segment of the right ventricle (segment RVD (9)), the latter being placed distally to the segment RVP (9) on said cardiac lead (1).

3. Cardiac probe (1) according to claim 2, characterized in that the RVP (8) and RVD (9) segments are connected to the same electrical potential.

4. Cardiac probe (1) according to claim 2 or 3, characterized in that said cardiac probe (1) comprises a portion (2,10) having greater flexibility than either of the two segments RVP (8) and RVD (9), preferably with a stiffness gradient.

5. Cardiac probe (1) according to claim 4, characterized in that said portion of probe body (2) comprises silicone and / or has a diameter adapted to reduce the thickness of an external insulator, such as polyurethane.

6. Cardiac probe (1) according to any one of claims 2 to 5, characterized in that an additional fixation means, for example a beard-type fixation means, is placed between the RVP (8) and RVD (9) segments, preferably on a portion of probe body (2).

7. Cardiac probe (1) according to any one of claims 2 to 6, characterized in that the distal end (4) implantable in the upper septum (5) of the heart is not in direct contact with the RVD segment (9), for example the RVD segment (9) and said distal end (4) implantable in the upper septum (5) of the heart are separated by a portion of probe body (2).

8. Cardiac probe (1) according to claim 7 characterized in that the RVD segment (9) is placed at a distance between 10 and 55 mm from the distal end (4) of the cardiac probe (1).

9. Cardiac probe (1) according to any one of claims 2 to 8, characterized in that the RVD segment (9) is at least 10mm away from the anode (3), preferably 25mm ± 5mm away from the anode (3).

10. Cardiac lead (1) according to any one of claims 7 to 9, characterized in that the flexibility of the portion (11) of the lead body (2) placed between the RVD segment (9) and the distal end (4) implantable in the upper septum (5) of the heart is greater than the flexibility of another portion (11) of lead body (2) in a proximal position relative to the RVP segment (8), in particular greater than the flexibility of the portion (10) of lead body (2) placed between the RVP (8) and RVD (9) segments.

11. Cardiac lead (1) according to any one of claims 2 to 10, characterized in that the cumulative linear length of the RVP (8) and RVD (9) segments is between 60 and 120 mm and preferably the RVP (8) and RVD (9) segments are arranged on the cardiac lead (1) so as to be positioned in anterior and posterior commissures of the right ventricle cavity of the heart once the cardiac lead (1) is implanted.

12. Cardiac probe (1) according to any one of claims 1 to 11, characterized in that it is a multi-wire coaxial cardiac probe (1), or a multi-lumen cardiac probe (1) equipped with micro-cables.

13. Cardiac probe (1) according to claim 12, characterized in that the multi-wire coaxial cardiac probe (1) comprises at least one insulated line configured for the transmission and delivery of high voltage.

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