Cardiac lead with optimized distal end

Abstract

The subject of the present invention relates to a cardiac lead comprising an optimized distal end, in particular optimized on the one hand for the implantation of said lead in a patient, and on the other hand for its durability. The present invention also relates to a method of manufacturing such a lead.

Description

Description Title of the invention: Optimized distal end cardiac probe

[0001] The object of the present invention relates to a cardiac probe comprising an optimized distal end, specifically optimized both for implantation of said probe in a patient and for its durability. Other aspects of the present invention also relate to a method for manufacturing such a probe.

[0002] EARLIER ART

[0003] The heart is a complex organ whose function is controlled by the application of precise electrical fields that cause specific muscles to contract at precise times to regulate the filling and ejection of blood into and out of the organ. The heart thus acts as a pump, ensuring blood circulation throughout the body. Structurally, the heart comprises four chambers (left and right atria and left and right ventricles) connected by four valves. However, sometimes the heart's function is impaired, necessitating the placement (more precisely, the implantation) of one or more medical devices that deliver electrical current(s) at the appropriate time(s) to ensure the organ's proper function.Such devices (such as implantable pacemakers and / or defibrillators) typically consist of an electronic unit configured for treatment by administering electrical current and a lead electrically connected to this unit. The unit is typically implanted away from the heart and is connected to it via the lead (typically through one of the veins supplying blood to the heart).

[0004] Such a probe is typically the component subjected to the greatest mechanical stress in the entire device (more than 100,000 heartbeats per day at an average of 70 beats per minute). This is why cardiac probes are extremely flexible to withstand the heartbeats without being damaged.

[0005] Furthermore, during lead implantation, precise placement within the heart is crucial for effective delivery of electrical therapy. During lead placement, the pacing lead is typically screwed into the cardiac tissue, for example, on the right ventricular side, specifically at the septum (using the recent "LBB" technique, for "left bundle branch," developed to directly capture conduction from the left bundle branch by penetrating the ventricular septum). Additionally, the distal end of the lead, which must be secured in the cardiac tissue, is more rigid than the main body. of the probe, in order to allow for implantation. Furthermore, the practitioner (such as a surgeon or electrophysiologist) performing the implantation uses specific tools to achieve the best possible placement. One of these tools is a stylet that can be inserted into the probe until its tip is fully extended to facilitate implantation. The stylet's role is, in particular, to stiffen the probe during the implantation process.

[0006] Thus, during implantation, the practitioner must manipulate the probe in such a way as to induce a movement that allows the distal end to be screwed in. This screwing is typically achieved by rotating the probe around its longitudinal axis. However, as explained above, the probe must exhibit significant longitudinal flexibility to accommodate cardiac pulsations and other movements throughout its lifespan. The challenge of the procedure, therefore, lies in obtaining a probe with considerable flexibility, particularly in its longitudinal direction, while also possessing sufficient torque transmission properties to allow the distal end to be screwed in.

[0007] It should be noted that, typically in art, such properties are aided by the insertion of a mandrel into a lumen of the probe, allowing the mandrel to connect the proximal end of the probe to its distal end. Such a mandrel, typically made of a metallic material with low flexibility, allows for torque transmission. However, this necessitates an increased diameter of the probe and currently complicates its implantation. Indeed, the transmission of force(s)—particularly during implantation—to the distal end of the probe, which presents a combination of (very) flexible and rigid elements (such as a screw and optionally a mandrel), is a factor that promotes bending and breakage of all kinds.

[0008] Thus, one of the aims of the present invention is to help limit mechanical stresses that weaken the structure, particularly through kinks that deteriorate the structural integrity of the probe, by proposing a cardiac probe with an optimized distal end.

[0009] SUMMARY OF THE INVENTION

[0010] The object of the present invention therefore relates to a cardiac probe comprising: a) a probe body having: - a median portion of a probe body with a cross-section of a first external diameter Dl, - a first distal portion with a cross-section of a second external diameter D2 different from the first external diameter Dl of the median portion of the probe body, - a light for the passage of a chuck in the middle portion of the body of the probe up to the first distal portion of the probe body, and - a distal end; and b) an anchoring device in cardiac tissue positioned to cover the distal end of the lead body, said anchoring device being configured to cover both the first distal portion of the lead body and at least a portion of the middle portion of the lead body, while extending distally from the first distal portion of the lead body so as to present a receiving space at the distal end of the lead body, said anchoring device comprising: - a distal portion (of the anchoring device) made of a first material and a proximal portion (of the anchoring device) made of a second material, - a conductive element positioned in the receiving space at the distal end of the probe body, said conductive element being configured to maintain in contact an inner surface of said anchoring device with an outer surface of the distal portion of the probe body, which distal portion of the probe body has a cross-section with an outer diameter D3 different from the outer diameter DI of the middle portion of the probe body, preferably the conductive element comprising at least one attachment element to a distal portion of the probe body, and - an anchoring element; characterized in that: - the first material of the distal portion of said anchoring device exhibits greater rigidity than the second material of the proximal portion of said anchoring device; and - the conductive element preferably includes a space for a chuck in communication with the light of the probe body.

[0011] Indeed, the combination of, on the one hand, a first material for the distal portion of the anchoring device with greater rigidity than the second material for the proximal portion of the anchoring device, and, on the other hand, a conductive element including a space for a stylet communicating with the lumen of the probe body, significantly improves the mechanical characteristics of the probe, particularly its distal end, during implantation with a stylet. In fact, according to prior art devices, a stylet with significant rigidity (compared to the probe body) can induce kinking in the probe, especially at the junction of the probe body with the distal portion of the probe.Thus, the distal end of the mandrel accommodated in the conductive element at the distal end of the probe according to the present invention limits the occurrence of kinking because the first material of the distal portion of said anchoring device is of a. rigidity greater than that of the second material of the proximal portion of said anchoring device. There is therefore a rigidity gradient which limits the occurrence of kinking(s).

[0012] Another object according to the present invention relates to a method for manufacturing a cardiac probe according to the present invention, comprising the following steps: - Step a): The conductive element is placed at the distal end of the probe body, - step b): the probe body fitted with the conductive element obtained following step a) is inserted at least partially into the distal portion of the anchoring device made of a first material, and - step c): the probe body is at least partially wrapped in the proximal position of the anchoring device by a second material less rigid than the first material of the distal portion of the anchoring device to form the proximal portion of the anchoring device.

[0013] Furthermore, the present invention relates to a method of inserting a cardiac probe as described herein into a patient.

[0014] Furthermore, the present invention relates to a method of treating a human heart using a cardiac probe as described herein.

[0015] DEFINITIONS

[0016] In the context of this invention, the term "lead body" refers to a portion of typically uniform diameter along its length located between the proximal (housing) and distal (heart) ends of the lead. The lead body comprises at least one electrical stimulation and / or sensing conductor that connects its proximal end to a distally located external interaction surface, such as the distal end of the lead. The lead conductors are insulated from the outside by one or more insulating coatings, typically made of silicone and / or polyurethane ("PU"). The lead conductors are isolated from each other within separate channels in the lead body.

[0017] By "middle portion" of probe body, it is understood in the context of the present invention to be a portion located between a distal portion (i.e. a portion located on the distal side of the probe) and a proximal portion (i.e. a portion located on the proximal side of the probe).

[0018] In the context of this invention, "cross-section" means the plane of intersection with a solid body contained in three-dimensional space, which plane is orthogonally positioned to the longitudinal axis of said solid body. In the case of a cardiac probe, the longitudinal axis is the line running the entire length of said probe at its center, that is, the set of points distributed along the entire length of the probe that are furthest embedded within it (i.e., furthest from the outer surface of the probe).

[0019] The cardiac probe according to the present invention is typically a (long) flexible (hollow or solid) tube and its various cross-sections therefore typically take the approximate form of circle(s) having one or more diameters, for example, of a first external diameter Dl.

[0020] By "first distal portion", it is understood in the context of the present invention to mean a portion of the probe located on the distal side of the probe and having different characteristics from the middle portion (for example, a second outer diameter D2 different from Dl), in particular in connection with a specific structural element at the distal end of the probe.

[0021] For the purposes of this invention, "light" means an internal cavity of the probe running parallel or concurrently with the longitudinal axis of the probe.

[0022] A "mandrel" is a tool typically inserted lengthwise into cardiac probes to increase their rigidity. Mandrels are typically made of metal alloys.

[0023] In general, in the present invention, a "distal end" is the end of an element placed closest to the distal end of the probe.

[0024] In the context of this invention, an "anchoring device" is understood to mean a device adapted to be anchored in cardiac tissue, such as cardiac muscle, particularly in a ventricle, atrium, or cardiac septum. The structural characteristics of such an anchoring device are described above.

[0025] In the context of the present invention, "reception space" means a space adapted to accommodate one or more objects, a portion of one or more objects, an assembly of several objects, or a portion of an assembly of several objects; that is to say, a delimited space with predetermined characteristics for such reception.

[0026] The "surface" of an object, in the context of the present invention, means all the points belonging to said object located at the interface between said object and its environment, a part of its environment or an interior space of said object.

[0027] In the context of the present invention, the "inner surface" of an object is understood to mean a surface embedded within an object, that is to say, partially or totally surrounded by the rest or part of said object.

[0028] In the context of this invention, the "exterior surface" of an object means a surface of said object exposed to its environment. Preferably, an exterior surface of said object is flat, convex, or locally concave without any of said surfaces being folded back on themselves. that is to say for this last case, without facing each other between two distinct portions of surfaces or in other words without at least two distinct portions of surfaces in contact with the external environment being substantially face to face.

[0029] In the context of the present invention, when several objects are assembled together, the expressions "interior surfaces" and "exterior surfaces" become relative to the specific object considered or to the set of objects assembled together, then considered as an "assembly" (or an equivalent term).

[0030] Thus, an "interior surface" of an object in such an assembly refers in the context of the present invention to any surface located inside said assembly.

[0031] By "inwardly directed surface" of an object, it is understood in the context of the present invention to mean a surface oriented towards the center of that object, or in other words substantially facing the heart of that object.

[0032] By "outwardly directed surface" of an object, it is understood in the context of the present invention to mean a surface not directed inwards towards that object, that is to say not substantially facing the core of that object.

[0033] DETAILED DESCRIPTION

[0034] Heart probe

[0035] The cardiac probe according to the present invention therefore comprises, as described above: a) a probe body; and b) a cardiac tissue anchoring device positioned to cover the distal end of the probe body, comprising in particular a conductor, characterized in that: - the first material of the distal portion of said anchoring device exhibits greater rigidity than the second material of the proximal portion of said anchoring device; and - the conductive element of the anchoring device includes a space for a chuck in communication with the light of the probe body.

[0036] Thus, the lumen is configured to allow the passage of a stylet through the mid-portion of the probe body to the first distal portion of the probe body. Preferably, the lumen is configured to allow the passage of a stylet through the mid-portion of the probe body to both the mid-portion and the first distal portion of the probe body. Inserting a stylet into the cardiac probe increases its rigidity, thereby improving ease of implantation.

[0037] In one embodiment, the distal portion of the anchoring device is made of a first material and the proximal portion of the anchoring device is made of a second material.

[0038] A slot configured for the passage of a stylet through the mid-portion of the probe body to reach (and potentially beyond) the first distal portion of the probe body helps to prevent kinking or limit breakage during probe implantation when the distal portion of the anchoring device is made of one material and the proximal portion of the anchoring device is made of a second material. Such kinking or breakage is likely to occur at the junction of the two materials. In one embodiment, the two materials have significantly different stiffnesses. In another embodiment, the two materials have significantly similar stiffnesses.

[0039] In the cardiac tissue anchoring device, the conductive element, also typically referred to in the art as a "driver," is located in a distal portion of a cardiac probe according to the present invention. The conductive element's specific role is to guide an electrically conductive, deployable anchoring screw as it is extended for insertion into the cardiac tissue.

[0040] Preferably, the conductive element is made of a material with a stiffness equal to or greater than the stiffness of the mandrel, i.e., the stiffness of the mandrel material inserted into the conductive element when the probe is implanted.

[0041] Advantageously, the conductive element comprises a material inert to the biological environment, in particular a surface coating inert to the biological environment.

[0042] In a particular embodiment, the conductive element is made of a material inert to the biological environment, in particular of a rigidity equal to or greater than the rigidity of the mandrel, i.e. the rigidity of the material of the mandrel inserted into the conductive element during the implantation of the probe.

[0043] For example, the conductive element includes a metallic material, preferably inert to the biological environment, such as stainless steel or platinum.

[0044] Preferably, the conductive element extends beyond half the length of the anchoring device. In the context of this invention, "extending beyond half the length of the anchoring device" means that the anchoring device is configured such that at least a portion of the conductive element is located at half its length. This has the particular advantage of increasing the rigidity of the anchoring device and preventing, or at least limiting, kinking or breakage of the cardiac lead. In the context of this invention, "length of the anchoring device" refers to the constant length of the anchoring device, which excludes the length of the anchoring device with a deployed configuration of a deployable anchor screw, if applicable. In other In terms, the "length of the anchoring device" is, in the context of the present invention, the length of the anchoring device with its deployable anchoring screw, if applicable, in its folded form.

[0045] Advantageously, the anchoring device has a length between 5 mm and 75 mm, preferably between 10 mm and 50 mm, more preferably between 20 mm and 45 mm.

[0046] Preferably, the conductor length is between 2.5 mm and 75 mm, preferably between 5 mm and 50 mm, more preferably between 10 mm and 45 mm.

[0047] As an example, the conductor lengths as described above can be combined with the anchoring device lengths as also described above.

[0048] In one embodiment, the anchoring device comprises an anode positioned between the distal and proximal portions of said anchoring device, preferably with a proximal junction separating the anode from the proximal portion of said anchoring device, said proximal junction being filled or coated with a continuous material over its entire extent. Thus, the anode benefits from and / or contributes to the increased rigidity of the anchoring device with respect to elements located proximal to it, such as the probe body.

[0049] Indeed, an anode is typically made of a metallic material to ensure good electrical conductivity. Thus, an anode is typically a rigid structural element which, when placed in the probe, increases mechanical stresses. Positioning the anode in the anchoring device, that is, distally in the probe, helps to limit these mechanical stresses.

[0050] It is implied here that the anode is configured for implantation in a human body. The anode therefore has an external surface configured to be in electrical contact with fluids external to the cardiac probe.

[0051] Preferably, at the anchoring device, a proximal junction separates the anode from the proximal portion of said anchoring device, said proximal junction being filled or coated with a continuous material over its entire extent. The advantages of such a junction are numerous, for example: - limit protruding areas that could be "biological attachment points" increasing the risk of fibrosis and / or infection; - limit areas of structural weakness that could lead to one or more bends and / or breaks; and / or - to facilitate the implementation of the probe, especially with a catheter.

[0052] Thus, advantageously at the level of the anchoring device, a distal junction separates the anode from the distal portion (of said anchoring device), said The distal junction is filled or lined with a continuous material over its entire extent. The advantages of such a junction are identical to those given above for the proximal junction.

[0053] Preferably at the anchoring device, a distal junction separates the anode from the distal portion (of said anchoring device), said distal junction being filled or coated with a continuous material over the entire extent of said distal junction and in that the anode and the distal portion have the same outside diameter value.

[0054] Advantageously, at the anchoring device level, the anode and the distal portion have the same outside diameter. Such a continuous diameter limits protruding areas that could be "biological attachment points," increasing the risks of fibrosis and / or infection, and / or limits areas of structural weakness that could lead to one or more kinks and / or ruptures, and / or facilitates probe placement, particularly with a catheter if necessary.

[0055] In one particular embodiment, at the anchoring device, the conductive element is configured to be at least partially covered by the anode. This has the advantage of limiting areas of structural weakness that could lead to one or more bends and / or breaks.

[0056] Other methods for limiting areas of structural weakness that could lead to one or more bends and / or breaks include, for example: - the probe body is sandwiched between the conductive element and the anode; and / or

[0057] - the anode is annular in configuration and the conductive element is inserted into the ring, preferably with a portion of the probe body.

[0058] Advantageously, a first electrically conductive wire is included in the probe body and electrically connected to the anode.

[0059] Thus, the first electrically conductive wire (contained within the probe body and electrically connected to the anode) has an outer sheath made of an insulating material. This allows for easier control of the electrical flow and the location of its delivery (instead of uncontrolled current losses). Such an outer sheath therefore increases the safety and accuracy of the current delivered or detected in the implanted patient.

[0060] In one particular embodiment, several electrically conductive wires are included in the probe body and electrically connected to at least one anode.

[0061] In a particular embodiment, the probe body includes at least one second electrically conductive wire.

[0062] Advantageously, at least one second electrically conductive wire is connected to the conducting element. When the conducting element is also connected to the first element, it is not the same as the second. electrically conductive element (implicit here), this allows for easier energizing of the cathode.

[0063] In a particular embodiment, said at least a second electrically conductive wire is electrically connected to the anchoring element.

[0064] In a particular embodiment, said at least a second electrically conductive wire comprises an outer sheath made of an insulating material.

[0065] Thus, preferably, the cardiac probe according to the present invention is characterized in that: - a first electrically conductive wire is included in the probe body and electrically connected to the anode; - the first electrical conductor wire includes an outer sheath made of an insulating material; - the probe body includes at least one second electrically conductive wire; - said at least one second electrically conductive wire is connected to the conductive element; - said at least one second electrically conductive wire is electrically connected to the anchoring element; and - said at least one second electrically conductive wire includes an outer sheath made of an insulating material.

[0066] In a particular embodiment, the probe body includes a second distal portion with a cross-section of an outside diameter D3 different from the second outside diameter D2 of the probe body.

[0067] Preferably, the conductive element includes at least one attachment element to a distal portion of the probe body. This has the advantage of allowing the probe body to be as close as possible to the distal end of said probe and improving its structural integrity, particularly by offering "sandwich" sections.

[0068] In one particular embodiment, the anchoring device includes at least one compartment configured to receive at least one pharmaceutical product, such as a steroid gel, and / or at least one antibiotic. This has the advantage of allowing specific and dedicated pharmaceutical administration to facilitate, or even enable, the implantation of said probe, while avoiding inflammation and / or infection.

[0069] In particular, the compartment (of the anchoring device configured to receive at least one pharmaceutical product) is in contact with, or inserted into, the conductive element. Such an arrangement allows for a compact design.

[0070] In addition, the conductive element is configurable to allow facilitation / control of the administration of said at least one pharmaceutical product.

[0071] For example, the compartment (of the anchoring device configured to receive at least one pharmaceutical product) communicates with at least one opening configured for controlled release of said pharmaceutical product into a biological environment external to the implanted cardiac lead. Such control can be achieved by using an excipient with a controlled dissolution rate.

[0072] Preferably, the anchoring device includes at least one compartment configured to receive a pharmaceutical product, such as a steroid gel and / or at least one antibiotic, and in that the compartment communicates with at least one opening configured for controlled diffusion of said pharmaceutical product into a biological environment external to the implanted cardiac lead.

[0073] Advantageously, an assembly element is placed between the probe body and the anode, which anode at least partially covers said assembly element.

[0074] Advantageously, the assembly element includes at least one opening configured for the passage of at least one electrically conductive wire, said at least one electrically conductive wire preferably comprising at least one outer sheath made of at least one insulating material.

[0075] Advantageously, said at least one electrically conductive wire is fixed (in the opening of the assembly element) by gluing, and preferably the gluing has been carried out with an adhesive comprising at least one insulating material for said at least one outer sheath of said at least one electrically conductive wire.

[0076] Preferably, the glue comprising at least one insulating material comprises a high volatility (particularly compared to the average in the art) of its solvent(s) and / or a low solubilizing power (particularly compared to the average in the art).

[0077] In a particular embodiment, the adhesive comprising at least one insulating material has a high volatility-to-solubilizing power ratio (particularly in comparison with the average of the latter in art).

[0078] Advantageously, the probe body in step c) was continuously wrapped, i.e., so as to form structural continuity, with the distal portion of the anchoring device or with the anode, as applicable. Such structural integrity improves the strength of the probe body and thus: - limit protruding areas that could be "biological attachment points" increasing the risk of fibrosis and / or infection; - limit areas of structural weakness that could lead to one or more bends and / or breaks; and / or - to facilitate the implementation of the probe, especially with a catheter.

[0079] The object of the present invention therefore relates to a cardiac probe such as described above, configured for implantation and HIS and / or LBB stimulation. Such a probe has a suitable diameter, for example between 1 mm and 5 mm, preferably between 2 mm and 4.5 mm, or between 3 mm and 4 mm.

[0080] Process

[0081] The object of the present invention therefore also relates to a method for manufacturing a cardiac probe as described herein, comprising the following steps: - Step a): The conductive element (as described above) is placed at the distal end of the probe body, - step b): the probe body fitted with the conductive element obtained following step a) is inserted at least partially into the distal portion of the anchoring device made of a first material, and - step c): the probe body is at least partially wrapped in the proximal position of the anchoring device by a second material less rigid than the first material of the distal portion of the anchoring device to form the proximal portion of the anchoring device.

[0082] Preferably, step c) is successive to step b) which is itself successive to step a).

[0083] In a particular embodiment, step b) is successive to step c) which is itself successive to step a).

[0084] Preferably in the method according to the present invention, an anode is placed between the distal portion of the anchoring device and the proximal portion of the anchoring device. Thus, the anode benefits from and / or contributes to the increased rigidity of the anchoring device with respect to the elements located proximal to it, such as the probe body.

[0085] Preferably in the method according to the present invention, an assembly element is placed between the probe body and the anode, the anode at least partially covering said assembly element. The assembly element thus benefits from the rigidity of the covering anode, which limits mechanical stresses on the covered portion. Furthermore, the assembly element is placed distally within the probe, i.e., within the anchoring device, which also limits mechanical stresses.

[0086] More preferably, an anode is placed between the distal portion of the anchoring device and the proximal portion of the anchoring device, and an assembly element is placed between the probe body and the anode, the anode at least partially covering said assembly element.

[0087] Preferably, the assembly element includes at least one opening configured for the passage of at least one electrically conductive wire. Advantageously, said at least one conductive wire is intended to make contact with the anode.

[0088] Advantageously, at least one electrically conductive wire includes at least one outer sheath made of at least one insulating material. This makes it easier to control the electrical flow and the location of its delivery (instead of having uncontrolled current losses). Such an outer sheath therefore increases the safety and accuracy of the current delivered or detected in the implanted patient.

[0089] Furthermore, it is advantageous that at least one electrically conductive wire is fixed by gluing. This facilitates the manufacture of such a probe.

[0090] Preferably, the manufacturing process according to the present invention is characterized in that the assembly element comprises at least one opening configured for the passage of at least one electrically conductive wire, in that said at least one electrically conductive wire comprises at least one outer sheath made of at least one insulating material, and in that said at least one electrically conductive wire is fixed by gluing.

[0091] Preferably, the bonding is performed with an adhesive comprising at least one insulating material for said device, at least one outer sheath for said device, and at least one electrically conductive wire. This also helps to control the electrical flow and the location of its delivery (instead of having uncontrolled current losses) and thus increases the safety and accuracy of the current delivered or detected in the implanted patient.

[0092] In one embodiment, the probe body of step c) is continuously wrapped (i.e., so as to form a continuous sheath) with the distal portion of the anchoring device or with the anode, as appropriate. This wrapping improves the physical characteristics and physiological tolerance of the probe by limiting protruding areas that could be "biological attachment points" increasing the risk of fibrosis and / or infection, by limiting areas of structural weakness that could lead to kinking and / or rupture, and / or by facilitating probe insertion, particularly with a catheter (by avoiding attachment points).

[0093] Methods

[0094] The object of the present invention also relates to the method of inserting a cardiac probe as described herein into a patient.

[0095] The insertion of such a probe is done by any applicable surgical method, in particular by inserting said probe into one of the veins supplying the heart.

[0096] Furthermore, the present invention relates to a method of treating a human heart using a cardiac probe as described herein.

[0097] Within the framework of the present invention, any treatment method, in particular a method of cardiac stimulation (heart rhythm management and / or defibrillation) can be applied via the use of a probe according to the present invention.

[0098] FIGURES

[0099] [Fig 1] Figure 1 is an overall representation of a probe according to the present invention.

[0100] [Fig 2] Figure 2 is a schematic representation of the distal end of a probe according to the present invention in which the different portions of the distal end are identified.

[0101] [Eig3] Figure 3 is a representation of a probe tip as found in Figure 2 in which the various constituent elements of the distal tip are identified and in which the anchoring device includes a conductive element in the receiving space.

[0102] Below is a description of the figures:

[0103] Figure 1 represents an overview of a cardiac probe 1 according to the present invention comprising a probe body 2 and an anchoring device 7 at its distal end.

[0104] Figure 2 represents the distal end of a cardiac probe 1 according to the present invention comprising a tubular probe body 2 having a median portion 3 of probe body 2 with a cross-section of a first external diameter Dl.

[0105] The cardiac lead 1 according to figure 2 is also configurable for implantation and HIS and / or LBB stimulation.

[0106] Figure 2 further represents the distal end of a cardiac probe 1 according to the present invention comprising an anchoring device 7 in cardiac tissue.

[0107] In Figure 2, the probe body 2 also includes a first distal portion 4 with a cross-section of a second outside diameter D2 different from the first outside diameter Dl of the median portion 3 of the probe body 2.

[0108] In Figure 2, the probe body 2 further includes a light 5 for the passage of a stylet in the middle portion 3 of the probe body 2 to the first distal portion 4 of the probe body 2 (cavity shown only in Figure 2 in the first distal portion 4).

[0109] In Figure 2, the probe body 2 includes a distal end 6, and the anchoring device 7 is placed on the probe to cover this distal end 6. The anchoring device 7 is also configured to cover both the first distal portion 4 of the probe body 2 and at least part of the middle portion 3 of the probe body 2. The anchoring device 7 is further configured to extend distally the first distal portion 4 of the probe body 2 so as to present a receiving space 8 at the distal end 6 of the probe body 2.

[0110] In Figure 2, said anchoring device 7 further comprises a distal portion 9 made of a first material and a proximal portion 10 made in a second material. Preferably, the first material of the distal portion 9 of said anchoring device 7 has a greater rigidity than the second material of the proximal portion 10 of said anchoring device 7.

[0111] In Figure 2, said anchoring device 7 further includes an anchoring element 12.

[0112] In Figure 2, the anchoring device 7 includes a reception space 13 for a chuck in communication with the light 5 of the probe body 2.

[0113] In Figure 2, the anchoring device 7 includes an anode 14 placed between the distal portion 9 and the proximal portion 10 of said anchoring device 7.

[0114] In Figure 2, the probe body 2 includes a second distal portion 19 with a cross-section of an outside diameter D3 different from the second outside diameter D2 of the probe body 2.

[0115] In Figure 2, the anchoring device 7 includes at least one opening 22 configured for controlled diffusion of a pharmaceutical product into a biological environment external to the implanted cardiac lead 1.

[0116] Figure 3 shows a particular embodiment of a distal end of a cardiac probe 1 according to the present invention, in which features of Figure 2 are found. The cardiac probe 1 according to Figure 3 comprises: a) a probe body 2 having: - a median portion 3 of probe body 2 with a cross-section of a first external diameter Dl, - a first distal portion 4 with a cross-section of a second external diameter D2 different from the first external diameter D1 of the median portion of the probe body 2, - a port 5 for the passage of a stylet in the middle portion 3 of the probe body 2 to the first distal portion 4 of the probe body 2, and - a distal end 6; and b) an anchoring device 7 in cardiac tissue positioned to cover the distal end 6 of the lead body 2, said anchoring device 7 being configured to cover both the first distal portion 4 of the lead body 2 and at least a portion of the middle portion 3 of the lead body 2, while extending distally the first distal portion 4 of the lead body 2 so as to present a receiving space 8 at the distal end 6 of the lead body 2, said anchoring device 7 comprising: - a distal portion 9 made of a first material and a proximal portion 10 made of a second material, - a conductive element 11 positioned in the receiving space 8 at the distal end 6 of the probe body 2, said conductive element 11 being configured to maintain in contact an inner surface of said anchoring device 7 with an outer surface of the distal portion of probe body 2, and - an anchoring element 12; in which: - the conductive element includes a reception space 13 for a chuck in communication with the light 5 of the probe body 2.

[0117] Preferably shown in Figure 3, the first material of the distal portion 9 of said anchoring device 7 has a stiffness greater than that of the second material of the proximal portion 10 of said anchoring device 7.

[0118] In Figure 3, the conductive element 11 is positioned in the receiving space 8 at the distal end 6 of the probe body 2. The conductive element 11 is configured to maintain contact between an inner surface of the anchoring device 7 and an outer surface of the distal portion of the probe body 2. As explained previously and applicable to Figure 3, the "inner surface of the anchoring device 7" is understood to mean a surface of the anchoring device 7 that is oriented inward when the anchoring device 7 is not placed on the probe. As explained previously and applicable to Figure 3, the "outer surface of the distal portion of the probe body 2" is understood, when the anchoring device 7 is not placed on the probe, to mean a surface of the probe body 2 that is oriented outward and not facing the center of the probe body.

[0119] In addition, the cardiac lead 1 according to figure 3 is configurable for implantation and HIS and / or LBB pacing.

[0120] In Figure 3, the conductive element 11 extends beyond half the length of the anchoring device 7.

[0121] In Figure 3, the anchoring device 7 includes an anode 14 placed between the distal portion 9 and the proximal portion 10 of said anchoring device 7.

[0122] In Figure 3, the anode 14 has an external surface configured to be in electrical contact with fluids external to the cardiac probe 1.

[0123] In Figure 3, a proximal junction 15 separates the anode 14 from the proximal portion 10 of said anchoring device 7, said proximal junction 15 is filled or coated with a continuous material over the entire extent of said proximal junction 15.

[0124] In Figure 3, a distal junction 16 separates the anode 14 from the distal portion 9, said distal junction 16 being filled or coated with a continuous material over the entire extent of said distal junction 16.

[0125] The anchoring device 7, as shown in Figure 3, is further characterized by a constant length L, thus excluding the anchoring element 12 from consideration when it is deployable. For example, and according to the embodiment shown in Figure 3, the length L of the device anchoring device 7 takes into consideration the length of the distal portion 9 of said anchoring device 7, the length of the anode 14, the length of the proximal portion 10 of said anchoring device 7, as well as the proximal junction 15 and the distal junction 16.

[0126] In Figure 3, the anode 14 and the distal portion 9 have the same outside diameter value.

[0127] In Figure 3, the conductive element 11 is configured to be at least partially covered by the anode 14.

[0128] In Figure 3, a first electrically conductive wire 17 is included in the probe body 2 and electrically connected to the anode 14.

[0129] In Figure 3, the first electrically conductive wire 17 includes an outer sheath made of an insulating material.

[0130] In Figure 3, the probe body 2 includes at least one second electrically conductive wire 18.

[0131] In Figure 3, said at least one second electrically conducting wire 18 is connected to the conducting element 11.

[0132] In figure 3, said at least a second electrically conductive wire 18 is electrically connected to the anchoring element 12.

[0133] In Figure 3, said at least a second electrically conductive wire 18 comprises an outer sheath made of an insulating material.

[0134] In Figure 3, the probe body 2 includes a second distal portion 19 with a cross-section of an outside diameter D3 different from the second outside diameter D2 of the probe body 2.

[0135] In Figure 3, the conductive element 11 includes at least one attachment element 20 to a distal portion 4.19 of probe body 2.

[0136] Preferably, the conductive element 11 comprises several fastening elements 20 (as shown).

[0137] Preferably, the conductive element 11 comprises several fastening elements 20 arranged such that the external diameter of said conductive element 11 at the crests of each fastening element 20 increases as one approaches the distal end of said conductive element 11 (as shown). Such an arrangement increases the mechanical strength of the probe body 2 at the contact (and fastening) interface with the conductive element 11.

[0138] In Figure 3, the anchoring device 7 includes at least one compartment 21 configured to receive, if necessary, a pharmaceutical product, such as a steroid gel and / or at least one antibiotic.

[0139] In figure 3, compartment 21 is in contact with, or inserted into, the conductive element 11.

[0140] In Figure 3, compartment 21 communicates with at least one opening 22 configured for controlled diffusion of said pharmaceutical product in a biological environment external to the implanted cardiac probe 1.

[0141] In Figure 3, an assembly element 23 is placed between the probe body and the anode 14, the anode 14 covering at least partially said assembly element 23.

[0142] It should be noted that these figures are merely illustrations of the present invention, which is not limited solely to the embodiments described.

Claims

Demands

1. Cardiac probe (1) comprising: a) a probe body (2) having: - a median portion (3) of probe body (2) with a cross-section of a first external diameter (Dl), - a first distal portion (4) with a cross-section of a second external diameter (D2) different from the first external diameter (D1) of the median portion of the probe body (2), - a light (5) for the passage of a stylet in the middle portion (3) of the probe body (2) to the first distal portion (4) of the probe body (2), and - a distal end (6); and b) an anchoring device (7) in cardiac tissue positioned to cover the distal end (6) of the lead body (2), said anchoring device (7) being configured to cover both the first distal portion (4) of the lead body (2) and at least a portion of the middle portion (3) of the lead body (2), while extending distally the first distal portion (4) of the lead body (2) so as to present a receiving space (8) at the distal end (6) of the lead body (2), said anchoring device (7) comprising: - a distal portion (9) made of a first material and a proximal portion (10) made of a second material, - a conductive element (11) positioned in the receiving space (8) at the distal end (6) of the probe body (2), said conductive element (11) being configured to maintain in contact an inner surface of said anchoring device (7) with an outer surface of the distal portion of the probe body (2), which distal portion of the probe body having a cross-section with an outer diameter D3 different from the outer diameter D1 of the middle portion of the probe body, preferably the conductive element (11) comprising at least one attachment element (20) to a distal portion (4, 19) of the probe body (2), and - an anchoring element (12); characterized in that: - the first material of the distal portion (9) of said anchoring device (7) has a greater rigidity than the second material of the proximal portion (10) of said anchoring device (7); and - the conductive element preferably includes a space for a chuck in communication with the light (5) of the probe body (2).

2. Cardiac probe (1) according to claim 1, characterized in that the conductive element (11) extends beyond half the length of the anchoring device (7).

3. Cardiac probe (1) according to claim 1 or 2, characterized in that the anchoring device (7) comprises an anode (14) placed between the distal portion (9) and the proximal portion (10) of said anchoring device (7), preferably with a proximal junction (15) separating the anode (14) from the proximal portion (10) of said anchoring device (7), said proximal junction (15) being filled or coated with a continuous material over the entire extent of said proximal junction (15).

4. Cardiac probe (1) according to claim 3, characterized in that a distal junction (16) separates the anode (14) from the distal portion (9), said distal junction (16) being filled or coated with a continuous material over the entire extent of said distal junction (16) and in that the anode (14) and the distal portion (9) have the same outside diameter value.

5. Cardiac probe (1) according to any one of claims 3 to 7, characterized in that the conductive element (11) is configured to be at least partially covered by the anode (14).

6. Cardiac probe (1) according to any one of claims 3 to 5, characterized in that: - a first electrically conductive wire (17) is included in the probe body (2) and electrically connected to the anode (14); - the first electrically conductive wire (17) includes an outer sheath made of an insulating material; - the probe body (2) includes at least one second electrically conductive wire (18); - said at least one second electrically conducting wire (18) is connected to the conducting element (11); - said at least one second electrically conductive wire (18) is electrically connected to the anchoring element (12); and - said at least one second electrically conductive wire (18) comprises an outer sheath made of an insulating material.

7. Cardiac probe (1) according to any one of claims 1 to 6, characterized in that the probe body (2) comprises a second distal portion (19) of cross-section having an outside diameter (D3) different from the second outside diameter (D2) of the probe body (2).

8. Cardiac lead (1) according to any one of claims 1 to 16, characterized in that the anchoring device (7) comprises at least one compartment (21) configured to receive a pharmaceutical product, such as a steroid gel and / or at least one antibiotic, and in that the compartment (21) communicates with at least one opening (22) configured for controlled diffusion of said pharmaceutical product into a biological environment external to the implanted cardiac lead (1).

9. Cardiac lead (1) according to any one of claims 1 to 8 configured for implantation and HIS and / or LBB pacing.

10. A method for manufacturing a cardiac probe according to any one of claims 1 to 20, comprising the following steps: - step a): the conducting element (11) is placed at the distal end (6) of the probe body (2), - step b): the probe body (2) provided with the conductive element (11) obtained following step a) is inserted at least partially into the distal portion (9) of the anchoring device (7) made of a first material, and - step c): the probe body is at least partially wrapped in the proximal position of the anchoring device by a second material less rigid than the first material of the distal portion (9) of the anchoring device (7) to form the proximal portion (10) of the anchoring device.

11. A manufacturing process according to claim 10, characterized in that: - an anode (14) is placed between the distal portion (9) of the anchoring device (7) and the proximal portion of the anchoring device (7); and - an assembly element (23) is placed between the probe body and the anode (14), the anode (14) covering at least partially said assembly element (23).

12. A manufacturing process according to claim 11, characterized in that: - the assembly element (23) includes at least one opening configured for the passage of at least one electrically conductive wire (17,18); - said at least one electrically conductive wire (17,18) comprises at least one outer sheath made of at least one insulating material; and - said at least one electrically conductive wire (17,18) is fixed by gluing.

13. A manufacturing method according to any one of claims 10 to 12, characterized in that the probe body of step c) is continuously wrapped with the distal portion (9) of the anchoring device (7) or with the anode (14), as appropriate.

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