Bipolar guidewire assembly for the transvascular stimulation of part of the autonomic nervous system of a human body, in particular for transvascular renal nerve stimulation or transvascular stimulation of the carotid body

Abstract

The invention essentially consists of an assembly for transvascular stimulation from inside an artery, which enables nerve stimulation of the region(s) of the autonomic nervous system around said artery by means of a bipolar guidewire having a suitably shaped distal end, it being possible for this stimulation to be either rapid or usable for mapping purposes.

Description

[0001] Description

[0002] Title: Bipolar guidewire assembly for transvascular stimulation of a part of an autonomic nervous system of a human body, in particular transvascular renal nerve stimulation or stimulation of the carotid glomus.

[0003] Technical field

[0004] The present invention relates to a set for transvascular stimulation of a part of an autonomic nervous system of a human body.

[0005] By "autonomic nervous system" is meant here and within the scope of the invention, the nervous system which directs the internal organic functions, and does not manage the voluntary mechanisms of the human body and is thus distinguished from the somatic system which concerns the body's relations with the outside world. The autonomic nervous system essentially innervates the internal organs and its sensory neurons of this system carry information from visceral functions to the central nervous system. Three categories are usually distinguished in the autonomic nervous system: the sympathetic nervous system, the parasympathetic nervous system and the enteric nervous system.

[0006] By "blood vessel" is meant here and within the scope of the invention, a vein or an artery.

[0007] The invention aims firstly to propose a simple and effective solution for trans-vascular stimulation, particularly for rapid diagnosis and / or for the purpose of mapping a nerve region, in particular with a view to a surgical or percutaneous intervention.

[0008] Although described with reference to an application of renal nerve stimulation, the invention applies to any other application of stimulation of a part of the autonomic nervous system of the human body. In particular, the invention also applies to nerve stimulation of the carotid glomus.

[0009] Prior art

[0010] Renal sympathetic denervation by catheter appears promising for treating pathologies / deficiencies that are primarily hypertension, but also heart failure, cardiac arrhythmias, diabetes, and pulmonary arterial hypertension. In particular, hypertension is a major health problem worldwide associated with a significantly increased risk of cardiac and stroke accidents.

[0011] Although the majority of patients agree to be treated long-term with effective medications to treat their hypertension, a large proportion of them remain non-compliant, particularly due to possible side effects and / or the inability of the medication to achieve blood pressure targets despite maximally tolerated regimens. In some cases, high blood pressure is refractory to drug treatments.

[0012] Thus, several new treatment strategies based on the implementation of medical devices have recently been developed to help control blood pressure by modulating the sympathetic nervous system.

[0013] Among these, renal sympathetic denervation has been the most studied.

[0014] Renal denervation is a technique consisting of performing superficial stimulation of the afferent and efferent nerves located around the renal arteries, either using an electrode catheter connected to a radiofrequency generator, or using a multi-electrode catheter connected to an ultrasound generator, or using a catheter equipped at its distal end with needles for injecting an alcohol-based liquid product.

[0015] One of the major challenges of this denervation technique is the lack of landmarks along the renal arteries identifying the exact location of the part of the nerves to be destroyed and thus determining the areas to be treated to optimize the effectiveness of the denervation treatment.

[0016] Early trials of transcatheter renal artery denervation for resistant hypertension using a radiofrequency generator did not show consistent clinical efficacy, widely considered to be primarily due to procedural factors that limited the assessment of the completeness of denervation achieved.

[0017] According to the authors of [1], the difficulty of predicting renal denervation and the controversy surrounding the paradigm of renal denervation as an antihypertensive treatment owe much to the absence of means of evaluating the act during the procedure, that is, of a measurable criterion to confirm the success of the procedure. Authors have shown that:

[0018] - the aortic co-renal ganglia can be localized transvascularly with high-frequency unipolar electrical stimulation, at 10Hz under a current of 25mA of the inferior vena cava or the aorta, or its branches,

[0019] - stimulation of the aorticorenal ganglia induces arterial vasoconstriction and a concomitant increase in blood pressure,

[0020] - renal denervation blocks activation of the afferent renal nerve and subsequently abolishes renovascular responses to stimulation of the aorticorenal ganglia.

[0021] Publication [2], which mentions electrical stimulation at 20 Hz with 5 ms pulses under a current of 10 mA, makes a similar observation.

[0022] The authors of the publication [3] use a multi-electrode catheter marketed under the name "ConfidenHT™" with a distal end that deploys in the form of an ellipsoid with four branches, each supporting an electrode, by pressing a button on a handle. This catheter is very invasive because its diameter is large, around 2.67 mm (8 French) and if the authors mention the possibility of nerve mapping with such a catheter, this remains to be demonstrated given the deployed shape which cannot be truly moved within the artery to at least easily reach other nerve sites. The placement of this catheter is also not easy to achieve.

[0023] Thus, the devices proposed to date can be considered too invasive and are not necessarily reliable in guaranteeing mapping of a renal artery and / or not easy to implement.

[0024] There is therefore a need to improve renal nerve stimulation devices to overcome the above drawbacks.

[0025] More generally, there is a need for a medical device that allows nerve stimulation of a part of the autonomic nervous system to be carried out, which is simple, rapid and effective, particularly for the purposes of mapping or monitoring the effectiveness of denervation, and non-invasive. The aim of the invention is to meet this need at least in part.

[0026] Statement of the invention

[0027] To do this, the invention relates, according to a first alternative, to a set for transvascular stimulation of a part of an autonomic nervous system of a human body, comprising:

[0028] - an introducer or guide catheter, comprising at least one tubular introduction sheath, intended to be introduced into a blood vessel of the human body;

[0029] - at least one guide wire, called a bipolar guide wire, intended to be introduced into the tubular sheath of the introducer or the guide catheter, the guide wire comprising an electrically conductive core coated with an electrically insulating sheath on a central portion between the proximal end and the distal end of the electrically conductive core which is not electrically insulated over the remainder of the length of the guide wire, the distal end of the electrically conductive core being atraumatic for the blood vessel, and configured to be shaped with at least one point of contact with the blood vessel when it is in its stimulation position facing the part of the autonomic nervous system around the blood vessel,the electrically insulating sheath incorporating an electrically conductive element, a distal portion of which is visible on at least one part of the outer periphery of the insulating sheath so as to be in contact with the wall of the blood vessel and a proximal portion of which is visible on at least one part of the outer periphery of the insulating sheath so as to be accessible from outside the body (C) when the guide wire is introduced into the introduction sheath, the proximal portion serving as a connection to an electrode of an external electrical pulse generator, while the electrically conductive core of the bipolar guide wire serves as a connection to the other electrode of the external electrical pulse generator.,

[0030] Advantageously, the external diameter of the insulating sheath of the bipolar guide wire is between 0.35 and 0.96 mm.

[0031] According to an advantageous configuration, the electrode of the external generator of electrical pulses to be connected to the proximal portion of the electrically conductive core visible in the insulating sheath is the anode while that to be connected to the proximal end of the electrically conductive core is the cathode. According to an advantageous embodiment, the electrically conductive core is a straight wire whose distal portion comprises the contact shape which extends radially along the axis of the wire.

[0032] Several advantageous alternatives for realizing the contact form are possible.

[0033] Thus the form of contact may include:

[0034] - at least one loop at the end of the wire or near the right distal end of the wire;

[0035] - at least one ring, preferably at least two adjacent rings, near the right distal end of the wire;

[0036] - at least one free strand, preferably four strands at 90° to each other, near the right distal end of the wire.

[0037] According to an advantageous embodiment variant, the distal end of the electrically conductive core of the bipolar guide wire comprises one or more radiopaque markers.

[0038] The set can constitute a set of transvascular renal nerve stimulation, and in addition a set of renal denervation.

[0039] It can also constitute a carotid glomus stimulation set, and in addition a set for delivering a stent or a carotid dilation balloon.

[0040] The invention also relates to a method for nerve stimulation of a part of the autonomic nervous system of a patient and, where appropriate, surgical intervention, comprising the following steps: i / introduction of a guide catheter or the introducer into a femoral or radial artery of a human body; ii / introduction of a bipolar guide wire into the introduction sheath of the guide catheter or the introducer, the guide wire comprising an electrically conductive core coated with an electrically insulating sheath on a central portion between the proximal end and the distal end of the electrically conductive core which is not electrically insulated over the remainder of the length of the guide wire, the distal end of the electrically conductive core being atraumatic for the blood vessel,and configured to be shaped with at least one point of contact with the blood vessel when it is in its stimulation position facing the part of the autonomic nervous system around the blood vessel, the electrically insulating sheath incorporating an electrically conductive element of which a distal portion is visible on at least one part of the outer periphery of the insulating sheath so as to be in contact with the wall of the blood vessel and of which a proximal portion is visible on at least one part of the outer periphery of the insulating sheath so as to be accessible from outside the body (C), iii / electrical connection of an electrode of an external electrical pulse generator to be connected to the proximal portion of the electrically conductive core visible in the insulating sheath and electrical connection of the other electrode of the generator to the proximal end of the electrically conductive core,iv / direct bipolar nerve stimulation on the wire using the external electrical pulse generator; v / if necessary, surgical intervention of one or more areas stimulated according to step iv / .,

[0041] Thus, the invention consists of a transvascular stimulation assembly from inside an artery by means of a bipolar guide wire whose electrically conductive core comprises an atraumatic distal end and with at least one form of contact with the vein wall, which allows nervous stimulation of the zone(s) of the autonomic nervous system around the artery, this stimulation being able to be either rapid or for mapping purposes.

[0042] This nerve stimulation can include transvascular renal stimulation (artery or vein) of the areas of the sympathetic system likely to generate high blood pressure. This allows us to perfectly identify the nerve area(s) to be denervated in order to reduce or eliminate high blood pressure. This stimulation also allows us to verify the effectiveness of the denervation carried out previously.

[0043] It can also involve transvascular stimulation of the carotid glomus (artery or vein). By performing rapid stimulation, temporary induced arterial hypotension and / or bradycardia (heart slowing) can be observed. This makes it possible to predict bradycardia or arterial hypotension prior to a carotid angioplasty procedure and therefore to anticipate it and administer drugs to avoid this pitfall. The guide catheter or introducer of the stimulation assembly according to the invention can be completely conventional for the anatomy of the blood vessel to be diagnosed.

[0044] The electrical stimulation guidewire is a bipolar guidewire, with an electrically conductive core in its proximal and distal ends and exposed portions in the insulating sheath that are electrically conductive in order to connect them to the electrodes of an external electrical pulse generator.

[0045] The distal end of the electrically conductive core has an atraumatic contact shape that comes into contact with the precise area(s) of the blood vessel (artery or vein) opposite the endings of the nervous system to be electrically stimulated that is around the vessel.

[0046] Furthermore, the intensity of nerve stimulation required is low. Typically, the intensity of the delivered alternating current can range from 10 to 25 mA for approximately 10 to 60 seconds, at a frequency ranging from 200 to 2000 / min (10 to 20 Hz).

[0047] The handling of all the components of the assembly is simple: a surgeon in charge of the operation can thus easily connect the electrode, typically the anode of the external electrical pulse generator to the proximal portion of the conductive core which is visible in the sheath and then connect as usual the other electrode, typically the cathode to the proximal end of the core.

[0048] In summary, the advantages of a transvascular nerve stimulation set for diagnostic purposes are numerous, including:

[0049] - a medical device that is easy to put in place, including a bipolar guide wire of which only the distal end has a shape adapted to the desired stimulation;

[0050] - a reliable transvascular nerve stimulation device, which allows very precise mapping of the nerve zone(s) of a patient's autonomic nervous system;

[0051] - in addition to mapping before a denervation or carotid treatment procedure, a device that allows the effectiveness of the procedure to be checked during and after it,

[0052] - possibility of implementation on any existing guide catheter; - possibility of using a smaller, less invasive catheter typically 6 French in diameter and not 8 French as in state-of-the-art devices and especially before a possible surgical procedure;

[0053] - possibility of being able to use the usual wires or guides of cardiologists or surgeons and of being able to route conventional denervation catheters

[0054] Inserting the bipolar guide wire into an insertion sheath of a guide catheter or introducer is very simple and easy to implement and can be carried out as usual by an assistant or nurse, who does not need to have any special skills for this task.

[0055] Other advantages and characteristics will become more apparent upon reading the detailed description, given for illustrative and non-limiting purposes, with reference to the following figures.

[0056] Brief description of the drawings

[0057] [Fig 1] Figure 1 is a schematic view illustrating the use of a renal nerve stimulation assembly according to the invention with a guide catheter and a bipolar guide wire according to the invention, the guide catheter being introduced directly into a peripheral artery of a patient.

[0058] [Fig 2] Figure 2 shows the arrangement of the bipolar electrical stimulation guidewire of the assembly according to Figure 1 within a renal artery for nerve stimulation of the surrounding nervous system.

[0059] [Fig 3] Figure 3 is a perspective view of a bipolar guidewire, intended for use in a renal or carotid nerve stimulation assembly according to the invention.

[0060] [Fig 3A], [Fig 3B] Figures 3A and 3B are cross-sectional views along AA and along BB, taken at the level of the distal and proximal portions respectively of the conductive electrical element embedded in the insulating sheath of the bipolar wire guide according to Figure 3.

[0061] [Fig 4] Figure 4 shows in cutaway view the composition of the central portion of the bipolar wire guide according to the invention.

[0062] [Fig 5A], [Fig 5B], [Fig 5C], [Fig 5D] Figures 5A to 5D are schematic views showing different embodiments of the contact shape of the distal end of an electrical stimulation guide wire according to the invention. [Fig 6] Figure 6 schematically shows different electrical stimulation positions in order to map the renal nervous system around the renal artery of a patient.

[0063] [Fig 7] Figure 7 is a schematic view illustrating the use of a carotid nerve stimulation assembly according to the invention with a guide catheter and a bipolar guide wire according to the invention, the guide catheter being introduced directly into a peripheral artery of a patient.

[0064] Detailed description

[0065] In the following description and throughout the present application, the terms "distal" and "proximal" are used with reference to the body of a patient for whom renal nerve stimulation or carotid nerve stimulation is followed, if applicable, by an intervention. Thus, the distal end of a guidewire is the end located furthest inside the patient during nerve stimulation for diagnosis.

[0066] Please note that the various elements are not necessarily represented to scale.

[0067] Figures 1 and 2 show a stimulation assembly according to the invention.

[0068] A guide catheter 1 is introduced into a femoral artery.

[0069] Such a guide catheter 1 may be of small diameter. It complies with the standards for existing peripheral intravascular catheters. The catheter 1 may include a tap-type flushing device 10, commonly referred to as a “valve” or “Y,” for flushing the interior of the catheter 1 with a suitable flushing liquid or for injecting contrast medium.

[0070] A bipolar electrical stimulation guide wire 4 is introduced into the sheath of the guide catheter 1. The length of this guide wire 4 is typically between 180 and 300 cm.

[0071] The bipolar guide wire 4 is illustrated in detail in Figures 3, 3A, 3B and 4. This bipolar guide wire 4 firstly comprises a metal core 40 in the form of a straight wire which extends from a proximal end 41 to a distal end 42.

[0072] The metal wire 40 is coated with an electrically insulating sheath 43 on a central portion between the proximal end 41 and the distal end 42. The distal end 42 of the metal core 40 is atraumatic for the blood vessel, and configured to be shaped into a form 400 with at least one point of contact with the blood vessel when it is in its stimulation position facing the part of the renal nervous system around the blood vessel.

[0073] This distal end 42 may be a more flexible portion than the rest of the guidewire, its flexibility thus ensuring secure contact of the shape 400 with the wall of the blood vessel. As shown in Figure 2, the shape 400 is in contact with the renal artery AR so as to stimulate the sympathetic nervous system S which surrounds it.

[0074] The metal core 40 is not electrically insulated over the remainder of the length of the wire guide.

[0075] Inside the electrically insulating sheath 43 is embedded a metallic layer 44 with the exception of its proximal 45 and distal 46 portions.

[0076] Thus, the distal portion 46 is visible over the entire outer periphery of the insulating sheath 44 so as to be in contact with the subcutaneous tissue of the body or with the artery through which the guide catheter 1 was introduced.

[0077] The proximal portion 45 is visible over the entire outer periphery of the insulating sheath 43 so as to be accessible from outside the body C when the guide wire is introduced into the introduction sheath of the guide catheter 1.

[0078] By this constitution of the bipolar guide wire 4, the proximal portion 45 of the integrated conductive element 44, constituted by a metallic layer, serves as a connection to an electrode of an electrical impulse stimulator external to the body, while the metallic core 40 of the bipolar guide wire serves as a connection to the other electrode of the external stimulator.

[0079] Thus, as shown in Figures 1 and 2, once the bipolar guide wire 4 is introduced with the distal end 42 in place in the blood vessel of the renal nervous system, an electrical connection 2, in particular in the form of a crocodile-type clamp, is connected, in particular by pinching to the stripped distal portion 45 of the metal layer 44 and is connected to an electrode, typically the anode of an electrical pulse generator 3, external to the body C, by means of an electrical power supply wire 30.

[0080] The other electrode, typically the cathode of the electrical pulse generator 3, external to the body C is connected by means of an electrical supply wire 3 to another electrical connection 5, in particular in the form of a crocodile-type clip, itself connected in particular by pinching to the proximal end 44 of the metal core.

[0081] In the example illustrated in Figure 2, the contact shape 400 may be a single loop which may even be located at the end of the distal end 42.

[0082] This loop 400 once deployed has a substantially circular shape, centered on the axis of the wire, which allows circumferential contact with the blood vessel, here the renal artery, once the wire 4 is in its stimulation position. Typically, the diameter of this circular shape 400 is variable from 3 to 8 mm in diameter.

[0083] The diameter of the wire 4, including its contact shape 400, may be compatible with the internal lumen of a sheath 11 of a guide catheter of 1.4 mm diameter (5 French) or 1.8 mm (6 French).

[0084] Nerve stimulation of the sympathetic nervous system S through the renal artery AR can take place by bipolar electrical stimulation between the cathode electrically connected to the core of the wire 4 and the anode electrically connected to the stripped portion 45 of the metal layer 44.

[0085] Different variations illustrated in Figures 5A to 5D may be provided to achieve the contact shape in the distal end 42 of the wire 4.

[0086] Figure 5 A relates to a form of contact which is a loop 400 at the end of the distal portion 40 of the wire 4. One or more radiopaque marker(s) (graduation) 60 is (are) advantageously implanted at the base of the loop 400 of the wire 4 in order to facilitate angiographic location.

[0087] Figure 5B relates to a contact form comprising three adjacent rings 401, 402, 403, near the right end of the wire 40. A radiopaque marker 61, 62, 63 is advantageously implanted at the base of each of these three rings 401, 402, 403. The radiopaque markers can be spaced every centimeter for example.

[0088] Figure 5C relates to a contact form with a single ring 404 near the right end of the wire 40. One or more radiopaque markers 64 are advantageously implanted at the base of the single ring 404. Figure 5C relates to a contact form with four strands 405 at 90° to each other, near the right end of the wire 40. A radiopaque marker 65 is advantageously implanted at the junction point of these strands 405.

[0089] Each of these variants can be used by the practitioner, for example, depending on the patient's anatomy.

[0090] According to an advantageous embodiment, the electrical stimulation element 4 may comprise stimulation markers positioned at different positions of the distal end 42.

[0091] Such a mode is illustrated in Figure 6: three markers implanted on the distal end 42 at three positions PI, P2, P3 spaced at a regular pitch, on each of which the stimulation clamp 5 can be positioned. Thus, knowing the precise distance between the contact shape(s) 400 to 405 and one of the positions PI to P3, it is possible to know precisely the area of ​​the nervous system S which will be stimulated.

[0092] Thus, a real mapping of the areas of the nervous system S that are sensitive or not to electrical stimulation carried out with the contact form 400 to 405 can be carried out.

[0093] This can help to know precisely the location of the area(s) to be denervated subsequently.

[0094] And subsequently, once the denervation operation has been carried out, to precisely note the area(s) actually denervated.

[0095] We now describe the method of renal nerve stimulation and, where appropriate, denervation, implemented by the assembly described previously.

[0096] This method is applied when a practitioner wishes to make a diagnosis of the renal artery, particularly with a view to denervation.

[0097] Step i / : a practitioner then introduces the guide catheter 1 into a femoral artery of a human body C.

[0098] Step ii / : the practitioner then introduces the bipolar guide wire 4 into the introduction sheath of the guide catheter 1, until ensuring that the distal end 42 with its contact shape 400 is well positioned in the renal artery AR to be diagnosed. He can then proceed with the electrical connection to the external electrical pulse generator 3.

[0099] Step iii / : Thus, the nurse or practitioner connects on the one hand an electrode of the external electrical pulse generator 3 to the proximal portion 45 of the layer 44 by pinching the connection clamp 2 on it and on the other hand the other electrode of the generator to the proximal end 41 of the metal core by pinching the connection clamp 5 on it.

[0100] Step iv / : Direct bipolar stimulation is performed on wire 4. More precisely, wire 4 conducts current in bipolar mode. The delivered current can be in the order of 15mA to 25mA with a pulse frequency between 200 and 2000 / min (10 to 20 Hz) for 1 min.

[0101] The response to this stimulation is then measured for each area of ​​the nervous system S with respect to the area in contact with the contact shape 400 to 405 of wire 4.

[0102] The renal nerve stimulation system, i.e. of the sympathetic nervous system around a renal artery, which has just been described, can also be used to achieve renal denervation.

[0103] Indeed, at the end of step iv / , if a nerve zone S has been identified as responding significantly to the stimulation, then by choosing a guide wire, for example the guide wire 4 which also incorporates a device for emitting radiofrequency signals, ultrasound or alcohol injection, renal denervation can be carried out according to a step v / without having removed any of the components of the assembly.

[0104] The assembly can also constitute a denervation control assembly because once this has been carried out, unipolar electrical stimulation can be carried out again on each area supposed to be denervated by means of a contact form 400 to 405 to verify that the denervation action has been carried out.

[0105] With the same components described and a guide catheter 1 and a bipolar electrical stimulation guide wire 4 adapted to the carotid anatomy, a carotid nerve stimulation assembly can be produced as shown schematically in Figure 7.

[0106] Steps i / to iv / remain the same with a contact shape 400 to 405 in contact with the carotid glomus. In this application, the stimulation assembly according to the invention may further constitute an assembly for delivering a stent or a carotid dilation balloon. Step v / therefore consists of delivering a stent or a carotid dilation balloon.

[0107] The invention is not limited to the examples which have just been described; in particular, it is possible to combine characteristics of the illustrated examples within non-illustrated variants.

[0108] Other variations and improvements may be provided without departing from the scope of the invention.

[0109] If in the illustrated examples the introduction of the guide or introducer catheter is done via the femoral route, that is to say in the femoral artery at the level of the groin, it can also be done via the radial route, that is to say in the radial artery at the level of the patient's wrist.

[0110] Instead of a guide catheter, an introducer can be used.

[0111] If in the illustrated examples, two separate clamps 2, 5 are used for electrical stimulation. It is also possible to envisage a single clamp with two separate connection portions 2, 5, one being dedicated to clamping the metal core and the other to clamping the metal layer.

[0112] List of cited references

[0113] [1]: Pierre C. Qian et al « Transvascular Pacing of Aorticorenal Ganglia Provides a stable Procedural Endpoint for Renal Artery Denervation », Cardiovascular Interventions VOL. 12, NO. 12, 2019, by the American College of Cardiology Foundation.

[0114] [2]: Masaomi Chinushi, et al. « Blood Pressure and Autonomic Responses to Electrical Stimulation of the Renal Arterial Nerves Before and After Ablation of the Renal Artery » Hypertension. 2013; 61 :450-456. http : / / hyper, ahaj ournals.org

[0115] [3]: Konstantinos P. Tsioufis et al. « Safety and performance of diagnostic electrical mapping of renal nerves in hypertensive patients » EuroIntervention 2018;14: el334-el342 publié en ligne Septembre 2018. DOI: 10.4244 / EIJ-D-18-00536

Claims

Claims 1. Set for transvascular stimulation of a part of an autonomic nervous system of a human body, comprising: - an introducer or guide catheter (1) comprising at least one tubular introduction sheath (13), intended to be introduced into a blood vessel of the human body; - at least one guide wire (4), called a bipolar guide wire, intended to be introduced into the tubular sheath of the introducer or the guide catheter, the guide wire (4) comprising an electrically conductive core (40) coated with an electrically insulating sheath (43) on a central portion between the proximal end (41) and the distal end (40) of the electrically conductive core which is not electrically insulated over the remainder of the length of the guide wire, the distal end (40) of the electrically conductive core being atraumatic for the blood vessel, and configured to be shaped with at least one point of contact with the blood vessel when it is in its stimulation position facing the part of the autonomic nervous system around the blood vessel,the electrically insulating sheath incorporating an electrically conductive element (44) of which a distal portion (46) is visible on at least one part of the outer periphery of the insulating sheath so as to be in contact with the wall of the blood vessel and of which a proximal portion (45) is visible on at least one part of the outer periphery of the insulating sheath so as to be accessible from outside the body (C) when the guide wire is introduced into the introduction sheath, the proximal portion (45) of the electrically conductive element serving as a connection to an electrode of an external generator of electrical pulses, while the electrically conductive core (40) of the bipolar guide wire serves as a connection to the other electrode of the external generator of electrical pulses., 2. Stimulation assembly according to claim 1, the external diameter of the insulating sheath of the bipolar guide wire being between 0.35 and 0.96 mm.

3. Stimulation assembly according to claim 1 or 2, the electrode of the external generator of electrical pulses to be connected to the proximal portion of the electrically conductive core visible in the insulating sheath being the anode while that to be connected to the proximal end of the electrically conductive core is the cathode.

4. Stimulation assembly according to one of the preceding claims, the electrically conductive core being a straight wire whose distal end comprises the contact shape which extends radially along the axis of the wire.

5. A stimulation assembly according to claim 4, the contact shape comprising at least one loop at the end of the wire or near the right distal end of the wire.

6. A stimulation assembly according to claim 4, the contact shape comprising at least one ring, preferably at least two adjacent rings, near the right distal end of the wire.

7. Stimulation assembly according to claim 4, the contact form comprising at least one free strand, preferably four strands at 90° to each other, near the right distal end of the wire.

8. Stimulation assembly according to one of the preceding claims, the distal end of the electrically conductive core of the bipolar guide wire comprising one or more radiopaque markers.

9. Stimulation assembly according to one of the preceding claims, constituting a transvascular renal nerve stimulation assembly, and furthermore a renal denervation assembly.

10. Stimulation assembly according to one of the preceding claims, constituting a carotid glomus stimulation assembly, and furthermore a carotid dilation stent or balloon delivery assembly.

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