Lbb defibrillation lead

Abstract

The present invention relates to a cardiac defibrillation lead comprising a lead body, an anode and a distal end which can be implanted in the upper septum of the heart, characterised in that said cardiac lead is configured to form a loop in the apical region of the heart.

Description

Description 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.

[0002] EARLIER ART

[0003] 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.

[0004] One of the solutions adopted in the art to overcome this technical problem is the so-called "LBB AP" technique (for "left bundle branch area pacing") developed to directly capture conduction from the left branch by penetrating the ventricular septum.

[0005] The left bundle branch placement site is typically 1 to 1.5 cm distal to the HIS area along the septal wall in the heart. During pacing lead placement, 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.

[0006] 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.

[0007] Patent documents EP1830920, US11911166B2, and EP3697493 illustrate the state of the art regarding the so-called "LBB" technique.

[0008] However, in the LBB position, the tip of the lead (also called the "lead tip") is implanted in the upper septum of the heart (versus the apex or lower septum for conventional leads used to treat bradycardia and / or tachycardia). Furthermore, LBB leads have a significantly smaller diameter compared to conventional leads used to treat tachycardia, primarily to maintain good puncture capacity and to limit the size of the insertion catheter.

[0009] 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 necessitates increasing the length of the electrode by approximately 50% in order to maintain a sufficient surface area. equivalent to a “traditional” electrode and limit the current density to preserve cardiac tissue when administering defibrillation therapy.

[0010] A conventional defibrillation electrode intended to be inserted into the right ventricle of the heart under the specific conditions of LBB thus leads to the exposure of most of its active surface in the right atrium, resulting in further 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 delivered therapy (particularly with regard to its positioning in a conventional treatment for 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.

[0011] Other known important factors must also be considered, in particular, factors leading to difficulties in extracting defibrillation probes.

[0012] The most critical adhesion points for such probes are located at the level of the defibrillation electrode known as the "SVC" (SVC stands for "superior vena cava"), which is 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.

[0013] Furthermore, various technologies have been developed to protect defibrillation electrodes, for example, by adding a silicone backing layer (called "back filling") to limit the formation of fibrosis between the electrode wires. While this technology is recognized as effective, it has the disadvantage of significantly stiffening the lead body at the defibrillation electrodes.

[0014] 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.

[0015] SUMMARY OF THE INVENTION

[0016] The object of the present invention relates to a cardiac defibrillation lead comprising a lead body, an anode and an implantable distal end in the upper septum of the heart, characterized in that said cardiac probe is configured to inscribe itself in a loop in the apical region of the heart.

[0017] It has indeed been discovered that by applying such a loop to the probe in the apical region of the heart, the tip of the probe is optimally positioned relative to the upper septum, that is, orthogonally or almost orthogonally to the upper septum, avoiding unwanted interactions with the tricuspid valve.

[0018] It should be noted that such a probe, in order to be implantable in the upper septum of the heart, must have specific diameter and flexibility characteristics that distinguish it from a conventional ventricular probe. Furthermore, the screw on the distal end of the probe, which allows for its implantation, is specifically designed to avoid, for example, perforating the septum.

[0019] 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).

[0020] In one embodiment, the probe takes charge of therapy delivery (commonly referred to as "pacing" in the art).

[0021] In one embodiment, the probe takes care of the detection (commonly referred to as "sensing" in the art).

[0022] For the purposes of this invention, "implantable distal end" means that the distal end is configured (or adapted) to be implanted.

[0023] In the context of this 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°, meaning that 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.

[0024] As is well known in medical terms, the interventricular septum is the wall separating the two ventricles of the heart. The interatrial septum extends from it. At the top, it constitutes the entire cardiac septum, namely the entire wall separating the right heart from the left heart. Thus, by "upper septum of the heart," we mean 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.

[0025] In the context of this 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 and right ventricles. 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.

[0026] DETAILED DESCRIPTION

[0027] Preferably, the probe body thus has a length adapted for its inscription in a loop along the apical region of the heart.

[0028] Such a loop is easily created by adjusting, for example, the length of the probe. For instance, by increasing the probe length (compared to current art practices), it is easy to create a loop according to the present invention.

[0029] For the purposes of this invention, "throughout the apical region of the heart" means that the probe runs parallel to or parallel to 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 remains 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.

[0030] Preferably, the length of the probe is adjusted to limit contact between the probe and cardiac tissues, particularly in the region apical of the heart. Indeed, by minimizing contact, the risk of generating fibrosis is reduced.

[0031] 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).

[0032] 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.

[0033] Furthermore, the probe body exhibits flexibility suitable for positioning the cardiac probe within 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 create a shape specifically adapted to the morphological characteristics of the patient's heart (which can be analyzed prior to implantation).

[0034] Preferably, the probe body has a flexibility adapted to positioning 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.

[0035] Advantageously, the probe includes at least one defibrillation electrode configured to be inserted into the right ventricle of the heart.

[0036] 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.

[0037] In a particular embodiment, the probe according to the present invention comprises different portions of different diameters.

[0038] Advantageously, the probe according to the present invention comprises at least two portions of different diameters.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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 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 of the probe body 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 of the probe body 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.

[0044] More advantageously, the probe according to the present invention comprises at least one portion of probe body with a diameter greater than a distal portion of probe body on said probe.

[0045] There are several advantages to having different diameters. In particular, different diameters of the lead body make it possible to limit the number of defibrillation electrodes, for example to just one, as well as to limit the risks of fibrotic adhesion while benefiting from the advantages of the distal portion of the lead, in particular the flexibility of this distal portion.

[0046] 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 inches), preferably about 1.5 mm (i.e., 4.5 French inches), 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 inches), preferably about 2.67 mm (i.e., 8 French inches). Thus, with such a defibrillation electrode diameter, the delivery surface area for the defibrillation treatment allows for maintaining a standard defibrillation surface area over a standard length.

[0047] 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)) allows its length to be reduced compared to conventional values.

[0048] 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 used for implanting these probes. As an example, catheters with a diameter of approximately 3.33 mm to approximately 3.67 mm (10 to 11 French) are suitable for a probe with a maximum diameter of approximately 2.67 mm (8 French).

[0049] [Rev. 4] Advantageously, the cardiac lead comprises at least one defibrillation electrode configured for insertion into the right ventricle of the heart, said at least one defibrillation electrode configured for insertion into the right ventricle of the heart is split into at least two segments preferably separated from each other, 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 lead.

[0050] 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. Furthermore, it is possible to tailor the treatment delivered with multiple electrodes: the electrodes with the best placement within the heart chamber can be selected for precise and patient-specific delivery.

[0051] 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).

[0052] Preferably, at least one RVP segment is positioned on the cardiac lead so as to be closer to the ventricular free wall than at least one RVD segment (i.e., once the lead is implanted in the heart).

[0053] In a particular embodiment, the different segments of the defibrillation electrode are connected to the same electrical potential.

[0054] Preferably, segments RVP and RVD are connected to the same electrical potential. Connecting the different segments (especially RVP and RVD) to the same electrical potential ensures that the delivery of electrical current is homogeneous between the segments (especially RVP and RVD).

[0055] In a particular embodiment, the different segments of the defibrillation electrode have similar, or even identical, contact surfaces with the biological environment. More specifically, at least the RVP segment and the RVD segment have similar, or even identical, contact surfaces with the biological environment. Indeed, identical or similar contact surfaces between the different segments (particularly RVP and RVD) with the biological environment also improve the homogeneity of the administered current.

[0056] 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.

[0057] Preferably, said probe comprises a portion having greater flexibility than any of the different segments of the defibrillation electrode, preferably with a stiffness gradient.

[0058] More specifically, said cardiac probe includes a portion exhibiting greater flexibility than either of the two segments RVP and RVD, preferably with a stiffness gradient.

[0059] In the context of the present invention, "stiffness gradient" refers to a rate of change in stiffness within a given portion of material.

[0060] 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, which could lead to breakage. Indeed, a stiffness gradient oriented so that the end of the transition section with the highest stiffness is adjacent to a probe section with lower flexibility (such as a defibrillation electrode) allows for a distributed flexibility / stiffness transition over a distance that minimizes stress 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.

[0061] In a particular embodiment, the RVP and RVD segments are separated by a portion of the probe body without a defibrillation electrode.

[0062] In this configuration, the probe is arranged optimally to offer the best flexibility across its entire range.

[0063] 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 specific patients.

[0064] In a particular embodiment, said portion of the probe body (separated) (including the RVP and RVD segments and devoid of a defibrillation electrode) comprises silicone and / or has a diameter adapted to reduce the thickness of an external insulator, such as polyurethane.

[0065] Silicone is an alternative material to polyurethane.

[0066] Silicone may also be of interest in the case, for example, of patients with particular sensitivities (such as allergies) to polyurethane, and vice versa.

[0067] Furthermore, the use of certain silicones is advantageous in terms of flexibility.

[0068] Advantageously, an additional fastening means, for example a barb-type fastening means, is placed between the RVP and RVD segments, preferably on a portion of the probe body.

[0069] Thus, it is possible to fix the probe in several locations within the heart chamber. This is particularly advantageous for avoiding the generation of fibroses linked to recurrent displacements that cause friction on the tissues of a foreign body within the heart chamber.

[0070] Advantageously, the distal end, preferentially 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, preferentially implantable in the upper septum of the heart, are separated by a portion of the probe body.

[0071] 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 unwanted pressure on the septum. This reduces the risk of septal perforation.

[0072] Advantageously, the RVD segment is placed at a distance of between 10 and 55 mm from the distal end of the cardiac probe.

[0073] 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.

[0074] It has been determined that this distance is optimal for the probe to be positioned perpendicular to the septum, thus freeing it from mechanical stresses that could induce unwanted pressure on the septum. This reduces the risk of septal perforation.

[0075] For the purposes of this invention, "placed at a distance of between 10 and 55 mm" means 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. When the distal end of the lead includes a fixation screw intended to be implanted in cardiac tissue, "the lead end" is to be distinguished from the fixation screw that is added, implanted, fixed, etc., at that location.

[0076] 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.

[0077] Typically, the fixing screw acts as the cathode.

[0078] 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.

[0079] 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.

[0080] Preferably, the anode is positioned at a distance of 9 mm ± 3 mm from the cathode.

[0081] In one particular embodiment, the cardiac lead according to the present invention has an integrated bipolar configuration. "Integrated bipolar" means that at least one of the defibrillation electrodes (specifically the RVD segment and / or the RVP segment) is configured to perform a dual function, for example, sensing and, if necessary, defibrillation. The advantage is that it reduces the number of conductive wires in the lead and optimizes the use of the conductive surfaces of the cardiac lead.

[0082] Thus, advantageously, the RVD segment is at least 10mm away from the anode, preferably 25mm ± 5mm from the anode.

[0083] 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.

[0084] Preferably, the RVD segment is located between 15 and 35 mm from the anode, more preferably between 20 and 30 mm from the anode, and even more preferably at 25 mm ± 3 mm from the anode.

[0085] In a particular embodiment, the flexibility of the portion of the probe body placed between the RVD segment and the distal end, i.e. the 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.

[0086] Thus, the superior 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 This design allows the distal end to be freed from mechanical constraints that could induce unwanted pressure on the septum. This reduces the risk of septal perforation. Furthermore, a lower flexibility in the lead body positioned between the RVP and RVD segments, and / or a greater flexibility in a portion of the lead body located proximal to the RVP segment, helps maintain the lead in a looped shape in the apical region of the heart.

[0087] Advantageously, the cumulative linear length of the RVP and RVD segments is between 60 and 120 mm.

[0088] 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.

[0089] 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.

[0090] In a particular embodiment, the RVP and RVD segments are arranged on the cardiac lead so as to be positioned in anterior and posterior commissures of the right ventricle cavity of the heart, once the cardiac lead is implanted.

[0091] 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.

[0092] 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).

[0093] The object of the present invention also relates to a method of manufacturing the probe described herein.

[0094] In particular, the object of the present invention relates to a method for manufacturing a probe as described herein, comprising a step of preforming the probe (i.e. before its implantation).

[0095] Preferably, the preforming step is carried out during the manufacture of the probe.

[0096] Alternatively, the pre-shaping step can be performed during implantation. The cardiac lead is then adapted for such a pre-shaping step.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] The object of the present invention also relates to the placement of a cardiac probe according to the present invention during its implantation.

[0101] 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.

[0102] Indeed, in one embodiment, the cardiac probe according to the present invention is configured to be compatible with a mandrel.

[0103] The mandrel has the advantage of being able to help the placement of the probe by temporarily rigidifying it during the placement process.

[0104] Indeed, in one embodiment, the cardiac probe according to the present invention is configured to be compatible with a placement catheter.

[0105] The catheter is a complementary tool to the stylet to help in the placement of the probe by using the rigidity provided by said catheter.

[0106] 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.

[0107] 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.

[0108] Such a probe makes it possible to increase the possibilities of applications, such as the insertion of means of administration or detection of current(s), or facilitation of implantation.

[0109] Preferably, the multi-wire coaxial cardiac lead includes at least one insulated line configured for high voltage transmission and delivery.

[0110] 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.

[0111] 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.

[0112] FIGURES

[0113] It should be noted that these figures are merely illustrations of the present invention, which is not limited solely to the embodiments described.

[0114] [Fig 1] Figure 1 represents a side view of the different portions of a probe according to the present invention.

[0115] [Fig 2] Figure 2 represents a three-dimensional view of a probe according to the present invention inserted into a heart viewed from the lower right side, opposite the right ventricle.

[0116] [Fig 3] Figure 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.

[0117] [Fig 4] Figure 4 represents a comparative three-dimensional cross-sectional view of three probes according to the present invention featuring several openings used for the passage of cables, chuck(s), etc.

[0118] Below is a detailed description of the figures.

[0119] 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 enables 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 Figure 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 Figure 1, the connection means 20 are linked one by one to the different active elements of the probe, 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.

[0120] Figure 2 shows a patient's heart into which a Cardiac probe 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 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.

[0121] In Figure 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 configuration of the cardiac lead 1.

[0122] The cardiac probe 1 shown in Figure 2 further presents 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.

[0123] Figure 3 also shows a heart into which a cardiac lead 1 according to the present invention is implanted. The heart is viewed from the rear, opposite the right ventricle. As in Figure 2, the cardiac lead 1 comprises a lead body 2, as well as a defibrillation electrode divided into two segments, one referred to as the proximal right ventricle segment RVP 8 and the other as the distal right ventricle segment RVD 9.

[0124] As in Figure 2, in Figure 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 it 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 configuration of the cardiac lead 1.

[0125] The cardiac probe 1 shown in Figure 3 has, in the same way as in Figure 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.

[0126] Figure 4 shows three-dimensional cross-sectional views of three different cardiac leads 1 that can be used in the context of the present invention. The first cardiac lead 12 (currently known as "Sprint Quattro Madel 6935MTM") on the left has a diameter of 8.6 F (F for French; IF = 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). The three cardiac leads (12, 13, 14) each have an insulating polyurethane surface coating 15. The 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 annular 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 probe (1) according to claim 1, characterized in that the probe body (2) has a length suitable for its inscription along a loop (6) throughout the apical region (7) of the heart.

3. Cardiac probe (1) according to claim 1 or 2, characterized in that the probe body (2) has a flexibility adapted to positioning said cardiac probe (1) in at least a portion of the apical region (7) of the heart.

4. Cardiac lead (1) according to any one of the preceding claims, 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 separate from each other, one referred to as the proximal segment of the right ventricle (RVP segment (8)) and the other referred to as the distal segment of the right ventricle (RVD segment (9)), the latter being placed distally to the RVP segment (9) on said cardiac lead (1).

5. Cardiac probe (1) according to claim 4, characterized in that the RVP (8) and RVD (9) segments are connected to the same electrical potential.

6. Cardiac probe (1) according to claim 4 or 5, 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.

7. Cardiac probe (1) according to claim 6, 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.

8. Cardiac probe (1) according to any one of claims 4 to 7, characterized in that a complementary fastening means, for example a beard-type fastening means, is placed between the RVP (8) and RVD (9) segments, preferably on a portion of probe body (2).

9. Cardiac probe (1) according to any one of claims 4 to 8, characterized in that the distal end (4) is not in direct contact with the RVD segment (9), for example the RVD segment (9) and said distal end (4) are separated by a portion of probe body (2).

10. Cardiac probe (1) according to claim 9 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).

11. Cardiac probe (1) according to any one of claims 4 to 10, characterized in that the RVD segment (9) is at least 10mm away from the anode (3), preferably 25mm ± 5 mm away from the anode (3).

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

13. Cardiac probe (1) according to any one of claims 4 to 12, 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 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.

14. Cardiac probe (1) according to any one of claims 1 to 13, characterized in that it is a coaxial multiwire cardiac probe (1), or a multi-lumen cardiac probe (1) equipped with micro-cables.

15. Cardiac probe (1) according to claim 14, characterized in that the multi-wire coaxial cardiac probe (1) comprises at least one insulated line configured for high voltage transmission and delivery.

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