Bipolar guidewire assembly for transvascular stimulation of parts of the autonomic nervous system of the human body, particularly for transvascular renal nerve stimulation or transvascular stimulation of the carotid body.

Abstract

Essentially, the present invention comprises an assembly for transvascular stimulation from within an artery, enabling nerve stimulation to one or more regions of the autonomic nervous system around an artery by a bipolar guidewire having a distal end of a suitable shape, and this stimulation can be performed rapidly or for mapping purposes.

Description

Technical Field

[0001] The present invention relates to an assembly for transvascular stimulation of a part of the autonomic nervous system of the human body.

[0002] In this specification and in the context of the present invention, the "autonomous nervous system" means the nerves that control visceral functions but do not manage the voluntary mechanisms of the human body, and thus is distinguished from the somatic system that is involved in the relationship between the body and the outside world. This autonomous nervous system essentially innervates the viscera, and the sensory neurons of this system transmit information regarding visceral functions to the central nervous system. This autonomous nervous system is usually classified into three different categories: the sympathetic nervous system, the parasympathetic nervous system, and the enteric nervous system.

[0003] In this specification and in the context of the present invention, "blood vessel" means a vein or an artery.

[0004] The present invention aims, first and foremost, to propose a simple and effective transvascular stimulation solution, particularly with a view to rapid diagnosis and / or mapping in the nerve area, especially in the context of surgical or percutaneous interventions.

[0005] The present invention is described by taking renal nerve stimulation applications as an example, but is applicable to any other uses for stimulating a part of the autonomic nervous system of the human body. In particular, the present invention is also applicable to nerve stimulation of the carotid body.

Background Art

[0006] Renal sympathetic denervation by the use of a catheter is considered to be a promising method for treating mainly hypertension, but also medical conditions / dysfunctions such as cardiac insufficiency, cardiac arrhythmia, diabetes, and pulmonary arterial hypertension.

[0007] In particular, high blood pressure constitutes a major global health problem associated with a significantly increased risk of heart attack and stroke.

[0008] While the majority of patients accept long-term treatment with medications that are effective in managing their hypertension, many do not adhere to their treatment plan, particularly due to potential side effects and / or the inability of the medication to achieve target blood pressure levels despite the maximum tolerated dose. In some cases, arterial hypertension is unaffected by medication.

[0009] Therefore, many novel therapeutic strategies based on the use of medical devices that help control blood pressure by regulating the sympathetic nervous system have recently been developed.

[0010] Renal sympathetic denervation is the most studied strategy in this group.

[0011] Renal denervation is a technique that involves stimulating the surface of afferent and efferent nerves located around the renal artery by using an electrode-equipped catheter connected to a radio frequency generator, a multi-electrode catheter connected to an ultrasound generator, or a catheter with a needle attached distally for injecting an alcohol-based liquid preparation.

[0012] One of the major challenges in this denervation technique is the lack of markers to identify along the renal artery that pinpoint the exact location of the nerve to be destroyed, and therefore, the inability to determine the zone to be treated in order to optimize the effectiveness of the denervation procedure.

[0013] Initial studies of renal artery denervation using catheters and radiofrequency assemblies for resistant hypertension have not demonstrated consistent clinical efficacy. This is widely attributed primarily to procedural factors that limited the methods by which the exhaustivity of the denervation achieved could be evaluated.

[0014] According to the authors of the following reference [1], the difficulties regarding the predictability of renal denervation and the controversy surrounding the paradigm of renal denervation as a treatment for hypertension are largely due to the lack of means to evaluate the actions during the procedure, i.e., the lack of measurable criteria to confirm the success of the procedure.

[0015] Some authors, The aorticorenal ganglia can be identified transvascularly by high-frequency unipolar electrical stimulation using 10 Hz and 25 mA current to the inferior vena cava, aorta, or its branches. Stimulation of the radial ganglion of the aorta induces arterial constriction and a resulting increase in blood pressure. Renal denervation inhibits the activation of afferent renal nerves, resulting in the elimination of renovascular responses to stimulation of the radial ganglion of the aorta. This indicates that.

[0016] The following reference [2] mentions electrical stimulation with a current of 10 mA, a pulse width of 5 ms, and a frequency of 20 Hz, and similar observations have been made.

[0017] The authors of the following document [3] themselves claim the product name "ConfidenHT 商標The authors use a commercially available multi-electrode catheter, which has a distal end that unfolds into an ellipsoidal shape divided into four branches when a button on the handpiece is pressed, with each branch supporting a single electrode. This catheter is highly invasive because its diameter is quite large, approximately 2.67 mm (8 French). While the authors mention the possibility of nerve mapping using such a catheter, this has not yet been demonstrated, considering that the unfolded shape cannot move freely within the artery and cannot easily reach other nerve sites. Furthermore, insertion of this catheter is not easy to achieve.

[0018] Therefore, the devices proposed so far are considered too invasive and are not necessarily reliable and / or easy to use for accurate renal artery mapping. [Overview of the Initiative] [Problems that the invention aims to solve]

[0019] Therefore, there is a need to improve the renal nerve stimulation device to overcome the aforementioned shortcomings.

[0020] More generally, there is a need for a medical device that allows for the stimulation of certain nerves in the autonomic nervous system, particularly for the purpose of mapping or checking the effects of denervation, and for non-invasive purposes, that is simple, rapid, and effective.

[0021] The objective of this invention is to satisfy this need at least partially. [Means for solving the problem]

[0022] To achieve this objective, according to the first option, the subject of the present invention is an assembly for transvascular stimulation of a part of the autonomic nervous system of the human body, An inserter or guide catheter comprising at least one tubular insertion sheath intended for insertion into the blood vessels of the human body; At least one guidewire, referred to as a bipolar guidewire, intended to be inserted into the tubular sheath of the inserter or the guide catheter, the guidewire comprising an electrically conducting core, the conductive core being covered with an electrically insulating sheath over the central portion between the proximal and distal ends of the conductive core, which is not electrically insulating over the rest of the length of the guidewire, the distal end of the conductive core being configured to be shaped to have at least one contact point with the blood vessel when it is at its stimulation site facing the portion of the autonomic nervous system around the blood vessel, the electrically insulating sheath incorporating an electrically conducting element, the proximal portion of the conductive element The proximal portion of the conductive element is exposed on at least a portion of the outer circumference of the insulating sheath so that the portion) is in contact with the wall of the blood vessel, and the proximal portion of the conductive element is exposed on at least a portion of the outer circumference of the insulating sheath so that it is accessible from outside the body (C) when the guidewire is inserted into the insertion sheath, the proximal portion being provided for connection to an electrode of an external electrical pulse generator, while the conductive core of the bipolar guidewire is provided for connection to another electrode of the external electrical pulse generator, the at least one guidewire It is equipped with.

[0023] Advantageously, the outer diameter of the insulating sheath of the bipolar guidewire is 0.35 to 0.96 mm.

[0024] According to one advantageous configuration, the electrode of the external electrical pulse generator to be connected to the exposed proximal portion of the conductive core in the insulating sheath is an anode, while the electrode to be connected to the proximal end of the conductive core is a cathode.

[0025] According to one advantageous embodiment, the conductive core is a straight wire, and the distal portion of the straight wire has a contact shape that extends radially with respect to the axis of the wire.

[0026] Regarding the contact shape, several advantageous alternative forms of the embodiment are possible.

[0027] Therefore, the contact shape may be at least one loop at the end of the wire or near the straight distal end of the wire; near the straight distal end of the wire, at least one ring, preferably at least two adjacent rings; near the straight distal end of the wire, at least one free strand, preferably four strands forming a 90° angle with each other and may include.

[0028] According to one advantageous alternative embodiment, the distal end of the conductive core of the bipolar guide wire is provided with one or more radiopaque markers.

[0029] The assembly may constitute a transvascular renal nerve stimulation assembly and may also constitute a renal denervation assembly.

[0030] The assembly may also constitute a carotid body stimulation assembly and may also constitute an assembly for delivering a balloon or stent for carotid body angioplasty.

[0031] The present invention is also a method for stimulating a part of the nerves of a patient's autonomic nervous system and, if necessary, performing surgical intervention, comprising i / Inserting a guide catheter or inserter into the femoral artery or radial artery of the human body; ii / Inserting a bipolar guidewire into the insertion sheath of the guide catheter or the inserter, wherein the guidewire comprises a conductive core, the conductive core being covered with an electrically insulating sheath over the central portion between its proximal and distal ends, the sheath being not electrically insulating over the rest of the guidewire's length, the distal end of the conductive core being configured to be shaped to have at least one contact point with the blood vessel when it is at its stimulation site facing the portion of the autonomic nervous system around the blood vessel, the electrically insulating sheath incorporating a conductive element, the distal portion of which is exposed over at least a portion of the outer circumference of the insulating sheath so as to be in contact with the wall of the blood vessel, and the proximal portion of which is exposed over at least a portion of the outer circumference of the insulating sheath so as to be accessible from outside the body (C); iii / to electrically connect one electrode of an external electrical pulse generator to be connected to the proximal portion of the exposed conductive core in the insulating sheath, and to electrically connect the other electrode of the generator to the proximal end of the conductive core; iv / Directly stimulating the bipolar nerve on the wire with the external electrical pulse generator; v / If necessary, perform surgical intervention on one or more zones stimulated in step iv / . The above method includes the following steps.

[0032] Accordingly, the present invention relates to an assembly for transvascular stimulation from within an artery using a bipolar guidewire, wherein the conductive core of the bipolar guidewire has a non-invasive distal end shaped to contact at least the venous wall to enable nerve stimulation of one or more regions of the autonomic nervous system around the artery, and this stimulation can be rapid or for mapping purposes.

[0033] This nerve stimulation can, in particular, be transvascular renal stimulation (either through arteries or veins) of zones of the sympathetic nervous system that may cause arterial hypertension. Thus, one or more nerve regions that should be denervated to alleviate or eliminate arterial hypertension can be clearly identified. This stimulation also allows for verification of the effects of prior denervation.

[0034] This may also include transvascular stimulation of the carotid body (through arteries or veins). By performing rapid stimulation, some induced transient arterial hypotension and / or bradycardia (decreased heart rate) may be observed. This makes it possible to predict bradycardia or arterial hypotension before carotid angioplasty, and therefore to anticipate it in advance and administer medication to avoid this risk.

[0035] The guide catheter or inserter of the stimulation assembly according to the present invention may be entirely conventional for the anatomical structure of the blood vessel to be diagnosed.

[0036] The electrical stimulation guidewire is a bipolar guidewire, which comprises a conductive core at its proximal and distal ends, and an exposed portion within a conductive insulating sheath so as to be connected to the electrodes of an external electrical pulse generator.

[0037] The distal end of the conductive core has a non-invasive contact shape that faces the terminal of an electrically stimulated nerve system and contacts one or more precise regions of a blood vessel (artery or vein) located around the blood vessel.

[0038] Furthermore, the required intensity of nerve stimulation current is low. Typically, the intensity of the supplied AC current can be in the range of 10–25 mA for approximately 10–60 seconds, with a frequency in the range of 200–2000 pulses / minute (10–20 Hz).

[0039] All components of the assembly are easy to operate. Thus, the surgeon performing the operation can easily connect one electrode, typically the anode of an external electrical pulse generator, to the proximal end of the conductive core exposed within the sheath, and then, in a conventional manner, connect the other electrode, typically the cathode, to the proximal end of the core.

[0040] In summary, the advantages of transvascular nerve stimulation assemblies for diagnostic purposes are numerous, including: It is a medical device that is easy to introduce, and in particular, it is an easy-to-introduce medical device that has a bipolar guidewire whose distal end is shaped appropriately for the desired stimulation; A highly reliable transvascular nerve stimulation device that enables extremely precise mapping of one or more nerve regions in a patient's autonomic nervous system; In addition to providing mapping before denervation or carotid body manipulation interventions, a device that allows the effectiveness of the intervention to be checked during and after the intervention. The possibility of using it with any existing guide catheter; The possibility of using thinner, less invasive catheters, typically having a diameter of 6 French rather than 8 French like conventional devices, particularly for use in the pre-surgical stage; The possibility of using wires or guides commonly used by cardiologists or surgeons, and the possibility of guiding conventional denervation catheters.

[0041] Inserting a bipolar guidewire into the insertion sheath of a guide catheter or inserter can be done very easily and readily, and can be performed very easily and routinely by an assistant or nurse without requiring any special skills.

[0042] Further advantages and features will be more clearly understood by reading the detailed description, which is non-limiting and refers to the attached drawings. [Brief explanation of the drawing]

[0043] [Figure 1] Figure 1 is a schematic diagram showing the use of a renal nerve stimulation assembly according to the present invention in conjunction with a guide catheter and bipolar guidewire according to the present invention, the guide catheter being directly inserted into the patient's peripheral artery. [Figure 2] Figure 2 shows the placement of the electrical stimulation bipolar guidewire of the assembly according to Figure 1 within the renal artery for nerve stimulation of the surrounding nervous system. [Figure 3] Figure 3 is a perspective view of a bipolar guidewire intended for use in a renal nerve or carotid somatic nerve stimulation assembly according to the present invention. [Figure 3A] Figure 3A is a cross-sectional view of the conductive element embedded in the insulating sheath of a bipolar guidewire according to Figure 3A, at the distal and proximal ends, on AA and BB, respectively. [Figure 3B] Figure 3B is a cross-sectional view of the conductive element embedded in the insulating sheath of a bipolar guidewire according to Figure 3B, at the distal and proximal ends, respectively, on AA and BB. [Figure 4] Figure 4 shows a cross-sectional view of the central part of a bipolar guidewire according to the present invention. [Figure 5A] Figure 5A is a schematic diagram illustrating different alternative embodiments of the contact shape of the distal end of an electrical stimulation guidewire according to the present invention. [Figure 5B]Figure 5B is a schematic diagram illustrating different alternative embodiments of the contact shape of the distal end of an electrical stimulation guidewire according to the present invention. [Figure 5C] Figure 5C is a schematic diagram illustrating different alternative embodiments of the contact shape of the distal end of an electrical stimulation guidewire according to the present invention. [Figure 5D] Figure 5D is a schematic diagram illustrating different alternative embodiments of the contact shape of the distal end of an electrical stimulation guidewire according to the present invention. [Figure 6] Figure 6 schematically shows various electrical stimulation locations to create a map of the renal nervous system around the patient's renal arteries. [Figure 7] Figure 7 is a schematic diagram showing the use of a carotid corpuscle nerve stimulation assembly according to the present invention in conjunction with a guide catheter and bipolar guidewire according to the present invention, the guide catheter being directly inserted into the patient's peripheral artery. [Modes for carrying out the invention]

[0044] In the following specification and throughout this application, the terms “distal” and “proximal” are used to refer to the part of the patient’s body to which renal nerve stimulation or carotid nerve stimulation, if applicable, is performed. Thus, the distal end of the guidewire is the end that is located furthest away in the patient’s body during nerve stimulation for diagnostic purposes.

[0045] It should be noted that various elements are not necessarily shown in actual size.

[0046] Figures 1 and 2 illustrate a stimulation assembly according to the present invention.

[0047] Guide catheter 1 is inserted into the femoral artery.

[0048] Such a guide catheter 1 may have a small diameter. The guide catheter 1 conforms to existing standards for peripheral intravascular catheters. The catheter 1 may be equipped with a valved rinsing device 10 (commonly known as a "valve" device or "Y" device) for rinsing the inside of the catheter 1 with a suitable rinsing solution or for injecting a contrast agent.

[0049] The electrical stimulation bipolar guidewire 4 is inserted into the sheath of the guide catheter 1. The length of this guidewire 4 is typically in the range of 180 to 300 cm.

[0050] The bipolar guidewire 4 is shown in detail in Figures 3, 3A, 3B, and 4. Firstly, the bipolar guidewire 4 comprises a metal core 40 in the form of a straight wire extending from a proximal end 41 to a distal end 42.

[0051] The metal wire 40 is covered with an electrically insulating sheath 43 in the central portion between the proximal end 41 and the distal end 42.

[0052] The distal end 42 of the metal core 40 is configured to be non-invasive to the blood vessel and, when its stimulation location faces a portion of the renal nervous system surrounding the blood vessel, to be shaped into a form 400 having at least one contact point with the blood vessel.

[0053] This distal end 42 may be a more flexible portion of the guidewire than the rest, and therefore its flexibility ensures that the shape 400 can safely contact the wall of the blood vessel. As shown in Figure 2, the shape 400 contacts the renal artery AR and stimulates the surrounding sympathetic nervous system S.

[0054] The metal core 40 is not electrically insulated over the remaining length of the guide wire.

[0055] The metal layer 44 is embedded inside the electrically insulating sheath 43, except for its proximal portion 45 and distal portion 46.

[0056] Therefore, the distal portion 46 is exposed along the entire outer circumference of the insulating sheath 44 so as to be in contact with the subcutaneous tissue or artery of the body into which the guide catheter 1 is inserted.

[0057] The proximal portion 45 is exposed along the entire outer circumference of the insulating sheath 43 so that it can be accessed from outside the body C when the guidewire is inserted into the insertion sheath of the guide catheter 1.

[0058] Through this configuration of the bipolar guidewire 4, the proximal portion 45 of the integrated conductive element 44, which is made of a metal layer, is provided for connection to one electrode of an external electrical-pulse stimulator, while the metal core 40 of the bipolar guidewire is provided for connection to the other electrode of an external stimulator.

[0059] Accordingly, as shown in Figures 1 and 2, once the bipolar guidewire 4 is inserted at its distal end 42 into a predetermined position within the blood vessels of the renal nervous system, the electrical connector 2, particularly in the form of an alligator clip, is connected to the exposed distal end 45 of the metal layer 44, particularly by the clip, and to an external electrode C, typically the anode of an electrical pulse generator 3, via power supply leads 30.

[0060] The other electrode, typically the cathode of an external electrical pulse generator 3, is connected to another electrical connection via an electrical supply lead wire 31.

[0061] 5. In particular, the clip is of the alligator clip type, which is itself connected to the proximal end 44 of the metal core, in particular by a clip connection.

[0062] In the example shown in Figure 2, the contact shape 400 may be a single loop that can be positioned at the tip of the distal end 42.

[0063] When unfolded, the loop 400 has a substantially circular shape centered on the wire axis, allowing the wire 4 to make circumferential contact with the blood vessel (in this case, the renal artery) when it is at its stimulation site. Typically, this circular shape 400 can vary in diameter from 3 to 8 mm.

[0064] The diameter of the wire 4, including its contact shape 400, can fit into the internal lumen of a guide catheter sheath 11 with a diameter of 1.4 mm (5 French) or 1.8 mm (6 French).

[0065] Nerve stimulation of the sympathetic nervous system S via the renal artery AR can be achieved by bipolar electrical stimulation between a cathode electrically connected to the core of the wire 4 and an anode electrically connected to the bare portion 45 of the metal layer 44.

[0066] Various alternative configurations shown in Figures 5A to 5D can be considered for forming a contact shape at the distal end 42 of the wire 4.

[0067] Figure 5A relates to the contact shape of the loop 400 at the tip of the distal portion 40 of the wire 4. It is advantageous that one or more radiopaque markers (scales) 60 are embedded in the base of the loop 400 of the wire 4 to facilitate identification by angiography.

[0068] Figure 5B relates to a contact shape comprising three adjacent rings 401, 402, and 403 near the straight end of the wire 40. Radiopaque markers 61, 62, and 63 are advantageously embedded in the base of each of these three rings 401, 402, and 403. The radiopaque markers may be spaced, for example, one at every centimeter.

[0069] Figure 5C relates to the contact shape of the wire 40 with a single ring 404 near the straight end. Advantageously, one or more radiopaque markers 64 are embedded in the base of the single ring 404.

[0070] Figure 5C relates to a contact shape having four strands 405 arranged at 90° angles to each other near the straight end of the wire 40. The radiopaque marker 65 is advantageously embedded at the points where these strands 405 intersect.

[0071] Each of these alternative forms may be used by the practitioner, for example, according to the patient's anatomical structure.

[0072] According to one advantageous embodiment, the electrical-stimulation element 4 may include a stimulation marker positioned differently from its distal end 42.

[0073] Such an embodiment is shown in Figure 6. Three markers embedded within the distal end 42 are arranged at equal intervals at three positions P1, P2, and P3, and a stimulation clip 5 may be placed on each marker. Thus, by knowing the precise distance between one or more contact shapes 400-405 and any one of positions P1-P3, it is possible to know precisely which zone of the nervous system S should be stimulated.

[0074] Therefore, it becomes possible to actually map the zones of the nervous system S that are sensitive to electrical stimulation performed with the contact shape 400-405 to the zones of the nervous system S that are not sensitive.

[0075] This can make it possible to precisely determine the location of one or more regions that should subsequently be denervated.

[0076] After the denervation surgery is performed, it is possible to know precisely which one or more areas were actually denervated.

[0077] Here, a method for performing renal nerve stimulation and, if necessary, denervating using the assembly described above is explained.

[0078] This method is applicable when the practitioner wishes to perform a diagnosis of the renal artery, particularly for the purpose of denervation.

[0079] Process i / : The practitioner inserts the guide catheter 1 into the femoral artery of human body C.

[0080] Process ii / : Next, the practitioner inserts the bipolar guidewire 4 into the insertion sheath of the guide catheter 1 until the distal end 42, which has the contact shape 400, is correctly positioned within the renal artery AR that is the subject of diagnosis.

[0081] Next, the practitioner may proceed to make an electrical connection to the external electrical pulse generator 3.

[0082] Step iii / : Therefore, the nurse or practitioner connects one electrode of the external electrical pulse generator 3 to the proximal portion 45 of layer 44 by clipping a connection clip 2 to it, and on the other hand, connects the electrode of the generator to the proximal end 41 of the metal core by clipping a connection clip 5 to it.

[0083] Process iv / : Direct bipolar stimulation is applied to the wire 4. More specifically, the wire 4 carries current in bipolar mode. The supplied current may be approximately 15mA to 25mA per minute, with a pulse frequency of 200 to 2000 times per minute (10 to 20Hz).

[0084] Next, the response to this stimulus is measured for each zone of the nervous system S that faces the zone in contact with the contact shape 400-405 of the wire 4.

[0085] Assembly for stimulating the renal nerves, i.e., the sympathetic nervous system around the renal arteries, can also be used to perform renal denervation.

[0086] Specifically, if, at the end of step iv / , it is identified that nerve zone S is particularly responsive to stimulation, renal denervation can be performed in step v / without removing any components of the assembly by selecting a guidewire, for example, a guidewire 4 that also incorporates a radio frequency signal, a device for emitting ultrasound, or a device for injecting alcohol.

[0087] The assembly may further constitute an assembly for checking denervation, because once such denervation is performed, the contact shapes 400-405 can be used to reapply unipolar electrical stimulation to each area that is presumed to have been denervated, thereby checking whether the denervation operation was performed correctly.

[0088] Using the same components described, as well as a guide catheter 1 and an electrical stimulation bipolar guidewire 4 suitable for the anatomy of the carotid body, a carotid nerve stimulation assembly can be constructed, as schematically illustrated in Figure 7.

[0089] Processes i / to iv / remain the same, and contact shapes 400 to 405 come into contact with the carotid body.

[0090] In this application, the stimulation assembly according to the present invention may further constitute an assembly for delivering a carotid angioplasty balloon or stent. Therefore, step v / consists of delivering a carotid angioplasty balloon or stent.

[0091] The present invention is not limited to the examples described herein, and in particular, it is possible to combine the features of the illustrated examples in modified forms not shown.

[0092] Other modifications and improvements can be provided without departing from the scope of the present invention.

[0093] In the illustrated example, the guide catheter or inserter is inserted via the femoral artery, i.e., the femoral artery in the groin, but it may also be inserted via the radial artery, i.e., the radial artery in one of the patient's wrists.

[0094] An inserter may be used instead of a guide catheter.

[0095] In the illustrated example, two different clips 2 and 5 are used for electrical stimulation, but it is also possible to assume that one clip has two different connection parts 2 and 5, one for clipping onto a metal core and the other for clipping onto a metal layer.

[0096] List of References JPEG2026520989000002.jpg74170

Claims

1. An assembly for transvascular stimulation of a part of the autonomic nervous system of the human body, An inserter or guide catheter (1) comprising at least one tubular insertion sheath (13) intended to be inserted into a blood vessel of the human body, At least one guidewire (4) referred to as a bipolar guidewire, intended to be inserted into the tubular sheath of the inserter or the guide catheter, wherein the guidewire (4) comprises a conductive core (40), the conductive core (40) is covered with an electrically insulating sheath (43) over the central portion between the proximal end (41) and distal end (40) of the conductive core, which is not electrically insulated over the rest of the length of the guidewire, and the distal end (40) of the conductive core is shaped to have at least one contact point with the blood vessel when it is at its stimulation site facing the portion of the autonomic nervous system around the blood vessel. The at least one guidewire (4) is configured such that the electrically insulating sheath incorporates a conductive element (44), the distal portion (46) of the conductive element (44) is exposed on at least a portion of the outer circumference of the insulating sheath so as to be in contact with the wall of the blood vessel, and the proximal portion (45) of the conductive element (44) is exposed on at least a portion of the outer circumference of the insulating sheath so as to be accessible from outside the body (C) when the guidewire is inserted into the insertion sheath, the proximal portion (45) of the conductive element is provided for connection to an electrode of an external electrical pulse generator, while the conductive core (40) of the bipolar guidewire is provided for connection to another electrode of the external electrical pulse generator. The assembly comprising:

2. The stimulation assembly according to claim 1, wherein the outer diameter of the insulating sheath of the bipolar guidewire is 0.35 to 0.96 mm.

3. The stimulation assembly according to claim 1 or 2, wherein the electrode of the external electric pulse generator to be connected to the exposed proximal portion of the conductive core in the insulating sheath is an anode, while the electrode to be connected to the proximal end of the conductive core is a cathode.

4. The stimulation assembly according to any one of claims 1 to 3, wherein the conductive core is a straight wire, and the distal end of the straight wire has a contact shape that extends radially with respect to the axis of the wire.

5. The stimulation assembly according to claim 4, wherein the contact shape includes at least one loop at the end of the wire or near the linear distal end of the wire.

6. The stimulation assembly according to claim 4, wherein the contact shape includes at least one ring, preferably at least two adjacent rings, near the linear distal end of the wire.

7. The stimulation assembly according to claim 4, wherein the contact shape includes at least one free strand, preferably four strands that are at a 90° angle to each other, near the linear distal end of the wire.

8. The stimulation assembly according to any one of claims 1 to 7, wherein the distal end of the conductive core of the bipolar guidewire is provided with one or more radiopaque markers.

9. A stimulation assembly according to any one of claims 1 to 8, comprising a transvascular renal nerve stimulation assembly and a renal denervation assembly.

10. A stimulation assembly according to any one of claims 1 to 9, comprising a carotid body stimulation assembly and also comprising an assembly for delivering a balloon or stent for carotid body angioplasty.

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