Bipolar guide wire assembly for transvascular stimulation of a portion of the autonomous neurous system of the human body, in particular for

Abstract

The present application essentially consists of an assembly for transvascular stimulation from within the artery, which assembly enables neurostimulation of the region (s) of the autonomic nervous system around the artery by a bipolar guidewire having a suitably shaped distal end, which stimulation may be fast or available 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 and in the context of the present invention, the "autonomic nervous system" refers to the nervous system that governs the function of internal organs but does not manage the voluntary mechanisms of the human body, thus being different from the somatic system which relates to the body's relationship with the outside world. The autonomic nervous system mainly dominates the internal organs, and the sensory neurons of this system carry information relating to visceral function to the central nervous system. The autonomic nervous system is generally divided into three different categories: the sympathetic nervous system, the parasympathetic nervous system and the enteric nervous system.

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

[0004] The present invention first seeks to propose a simple and effective transvascular stimulation solution, for the purpose of a particularly rapid diagnosis and / or for the mapping of a neural region, in particular for the purpose of a surgical operation or a percutaneous intervention.

[0005] Although described with reference to a renal nerve stimulation application, the present invention is applicable to any other application for stimulating a part of the autonomic nervous system of the human body. In particular, the present invention is also applicable to the nerve stimulation of the carotid body. BACKGROUND

[0006] Renal sympathetic denervation using a catheter has emerged as a promising method for treating pathologies / defects, mainly hypertension, but also including heart insufficiency, arrhythmia, diabetes and pulmonary arterial hypertension.

[0007] In particular, hypertension is a major health problem worldwide, associated with a significantly increased risk of cardiac events and stroke.

[0008] While most patients receive long-term treatment with drugs effective for treating their hypertension, a large proportion of these patients do not comply with their regimen, in particular due to possible side effects and / or because the drug does not reach the target blood pressure level despite the maximum tolerated dose. In some cases, arterial hypertension is not affected by drug treatment.

[0009] Therefore, many new treatment strategies based on the use of medical devices have recently been developed to help control blood pressure by modulating the sympathetic nervous system.

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

[0011] Renal denervation is a technique that consists in performing a surface stimulation of the afferent and efferent nerves located around the renal artery by using a catheter with electrodes connected to a radiofrequency generator, by using a multi-electrode catheter with its electrodes connected to an ultrasound generator, or by using a catheter equipped at its distal end with a needle for injecting an alcohol-based liquid product.

[0012] One of the main challenges of this denervation technique is the lack of identifying markers along the renal artery to identify the exact location of the nerve portions to be destroyed and thus to determine the area to be treated in order to optimize the effectiveness of the denervation treatment.

[0013] Early trials of renal artery denervation for resistant hypertension by catheter and using a radiofrequency generator have not shown consistent clinical effects, which is largely believed to be due to procedural factors limiting the good evaluation that can be made of the completeness of the denervation obtained.

[0014] According to the authors of [1], the difficulty of 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 action during the surgical procedure, i.e. the lack of measurable criteria to confirm the success of the surgical procedure.

[0015] Some authors have shown that:

[0016] - the aorticorenal ganglion in the inferior vena cava or in the aorta or in a branch thereof can be located transvascularly by high-frequency monopolar electrical stimulation at 10 Hz and using a current of 25 mA,

[0017] - the stimulation of the aorticorenal ganglion causes vasoconstriction of the artery and a concomitant increase in blood pressure,

[0018] - renal denervation blocks the activation of the afferent renal nerves and thus eliminates the renal vascular response to the stimulation of the aorticorenal ganglion.

[0019] Publication [2] mentions electrical stimulation at 20 Hz with 5 ms pulses at 10 mA current and makes similar observations.

[0020] The authors of publication [3] themselves adopt a commercially available multi-electrode catheter, the distal end of which is deployed in the form of an ellipsoid, each of the four branches supporting an electrode when a button in the handpiece is pressed. This catheter is highly invasive because of its considerable diameter, of the order of 2.67 mm (8 French), and although the authors mention the possibility of using such a catheter for nerve mapping, this remains to be proven because the shape deployed cannot really be moved within the artery in order to reach at least easily other nerve sites. The introduction of this catheter is also not easily achieved.

[0021] The devices proposed to date can therefore be considered to be too invasive and not necessarily reliable and / or easy to use for ensuring the mapping of the renal arteries.

[0022] There is therefore a need to improve the renal nerve stimulation devices in order to overcome the aforementioned drawbacks.

[0023] More generally, there is a need for a medical device that makes it possible to stimulate the nerves of a part of the autonomic nervous system and that is simple, quick and effective, in particular for the purposes of mapping or checking the effectiveness of denervation, and that is non-invasive.

[0024] The aim of the present invention is to meet this need at least in part. SUMMARY

[0025] To achieve this aim, according to a first alternative, the subject of the present invention is an assembly for transvascular stimulation of a part of the autonomic nervous system of the human body, comprising:

[0026] - an introducer or guide catheter comprising at least one tubular insertion sheath intended to be inserted into a blood vessel of the human body;

[0027] - at least one guide wire, called bipolar guide wire, intended to be inserted into the tubular sheath of the introducer or of the guide catheter, comprising an electrically conductive core coated with an electrically insulating sheath on a central portion between a proximal end and a distal end of the electrically conductive core, the electrically conductive core not being electrically insulated on the rest of the length of the guide wire, the distal end of the electrically conductive core being atraumatic with respect to the blood vessel and being configured to be shaped in a shape having at least one contact point with the blood vessel when the distal end of the electrically conductive core faces a portion of the autonomic nervous system located around the blood vessel in its stimulation position, the electrically insulating sheath comprising an electrically conductive element, a distal portion of the electrically conductive element being exposed on at least a portion of the outer periphery of the insulating sheath so that the distal portion of the electrically conductive element is in contact with the blood vessel wall, and a proximal portion of the electrically conductive element being exposed on at least a portion of the outer periphery of the insulating sheath so as to be accessible from the outside of the body (C) when the guide wire is inserted into the insertion sheath, the proximal portion of the electrically conductive element providing a connection to an electrode of an external electrical pulse generator, while the electrically conductive core of the bipolar guide wire provides a connection to another electrode of the external electrical pulse generator.

[0028] Advantageously, the outer diameter of the insulating sheath of the bipolar guide wire comprises between 0.35 mm and 0.96 mm.

[0029] According to an advantageous configuration, the electrode of the external electrical pulse generator to be connected to the exposed proximal portion of the electrically conductive core in the insulating sheath is an anode, while the electrode to be connected to the proximal end of the electrically conductive core is a cathode.

[0030] According to an advantageous embodiment, the electrically conductive core is a straight wire, the distal end having a contact shape extending radially with respect to the axis of the wire.

[0031] Many advantageous alternatives to the embodiment of the contact shape are possible.

[0032] Thus, the contact shape can comprise:

[0033] - at least one ring at the end of the wire or close to the straight distal end of the wire;

[0034] - at least one ring close to the straight distal end of the wire, preferably at least two adjacent rings;

[0035] - at least one free strand close to the straight distal end of the wire, preferably four strands at 90° from each other.

[0036] According to an advantageous alternative embodiment, the distal end of the electrically conductive core of the bipolar guide wire comprises one or more radiopaque markers.

[0037] The assembly can constitute a transvascular renal nerve stimulation assembly and also a renal denervation assembly.

[0038] The assembly can also constitute a carotid body stimulation assembly and also an assembly for delivering a carotid body angioplasty balloon or stent.

[0039] The application also relates to a method for stimulating a nerve of a part of the autonomic nervous system of a patient and, where appropriate, for performing a surgical intervention, the method comprising the following steps:

[0040] i / inserting a guide catheter or an introducer into the femoral or radial artery of the human body;

[0041] ii / inserting a bipolar guide wire into the insertion sheath of the guide catheter or of the introducer, the guide wire comprising an electrically conductive core, coated with an electrically insulating sheath on a central portion between a proximal end and a distal end of the electrically conductive core, the electrically conductive core not being electrically insulated on the rest of the length of the guide wire, the distal end of the electrically conductive core being atraumatic with respect to the blood vessel and being configured to be shaped in a shape having at least one contact point with the blood vessel when the distal end of the electrically conductive core faces a part of the autonomic nervous system around the blood vessel in its stimulation position, the electrically insulating sheath comprising an electrically conductive element, a distal portion of the electrically conductive element being exposed on at least a portion of the outer periphery of the insulating sheath so that the distal portion of the electrically conductive element is in contact with the blood vessel wall, and a proximal portion of the electrically conductive element being exposed on at least a portion of the outer periphery of the insulating sheath so as to be accessible from the outside of the body (C),

[0042] iii / making an electrical connection of one electrode of an external electrical pulse generator to be connected to the proximal portion of the exposed electrically conductive core in the insulating sheath, and of another electrode of the generator to the proximal end of the electrically conductive core,

[0043] iv / performing a direct bipolar nerve stimulation on the guide wire by the external electrical pulse generator;

[0044] v / where appropriate, performing a surgical intervention on the region or regions stimulated in step iv / .

[0045] The application thus consists of an assembly for performing a transvascular stimulation from within an artery, the stimulation being performed by a bipolar guide wire, the electrically conductive core of the bipolar guide wire comprising an atraumatic distal end having at least one shape in contact with the vein wall so as to allow a nerve stimulation of a region of the autonomic nervous system around the artery, the stimulation being able to be rapid or for mapping purposes.

[0046] The nerve stimulation can in particular be a transvascular (through the artery or through the vein) renal stimulation of a region of the sympathetic system liable to cause arterial hypertension. The nerve region to be denervated in order to reduce or eliminate arterial hypertension can thus be well identified. The stimulation also makes it possible to verify the effectiveness of a denervation previously performed.

[0047] This can also involve transvascular (through an artery or through a vein) stimulation of the carotid body. By performing a rapid stimulation, any induced temporary arterial hypotension and / or bradycardia (slowing of the heart beat) can be observed. This makes it possible to predict bradycardia or arterial hypotension before a carotid angioplasty procedure and thus to anticipate bradycardia or arterial hypotension and administer a drug to avoid this danger.

[0048] The guide catheter or introducer of the stimulation assembly according to the application can be entirely conventional for the anatomy of the blood vessel to be diagnosed.

[0049] The electrostimulation guide wire is a bipolar guide wire with a core that is electrically conductive at its proximal and distal ends and exposed portions in the insulating sheath that are electrically conductive, so that they can be connected to the electrodes of an external electrical pulse generator.

[0050] The distal end of the electrically conductive core has an atraumatic contact shape that comes into contact with the precise area of the blood vessel (artery or vein) facing the endings of the nervous system to be electrically stimulated and located around the blood vessel.

[0051] Furthermore, the intensity of the nerve stimulation current required is low. Typically, the intensity of the AC current delivered can be in the range of 10 mA to 25 mA at a frequency ranging from 200 / min to 2000 / min (10 Hz to 20 Hz) over a period of about 10 seconds to 60 seconds.

[0052] All the components of the assembly are easy to manipulate: the surgeon in charge of the operation can thus easily connect the electrode (typically the anode of an external electrical pulse generator) to the proximal portion of the electrically conductive core exposed in the sheath, and then connect the other electrode (typically the cathode) to the proximal end of the core in the usual way.

[0053] In summary, the advantages of the transvascular nerve stimulation assembly for diagnostic purposes are numerous and include:

[0054] - a medical device that is easy to introduce, in particular with a bipolar guide wire that has only the distal end with a shape suitable for the required stimulation;

[0055] - a transvascular nerve stimulation device that is reliable, making it possible to map the nerve areas of the autonomic nervous system of a patient very precisely;

[0056] - in addition to providing a map before a denervation or carotid body treatment intervention, the device makes it possible to check the effectiveness of the intervention during and after the intervention,

[0057] - the possibility of using it on any guide catheter present;

[0058] - the possibility of using thinner, less invasive catheters, generally having a diameter of 6 French instead of 8 French in the devices according to the prior art, in particular upstream of the possible surgical procedure;

[0059] - the possibility of using guide wires or guides habitually used by cardiologists or surgeons, and the possibility of being able to guide a conventional denervation catheter.

[0060] Insertion of the bipolar guide wire into the insertion sheath of the guide catheter or of the introducer is very simple and easy to perform and can be performed by an assistant or a nurse who does not need to have special skills to perform this task, as usual.

[0061] Further advantages and features will become more apparent on reading the detailed description, given by way of non-limiting illustration with reference to the following drawings. BRIEF DESCRIPTION OF DRAWINGS

[0062] Figure 1 Figure 1 is a schematic view of the use of a renal nerve stimulation assembly according to the present application, of a guide catheter and of a bipolar guide wire according to the present application, the guide catheter being inserted directly into a peripheral artery of a patient.

[0063] Figure 2 Figure 2 shows the arrangement of the electrical stimulation bipolar guide wire according to the assembly of the present application, for nerve stimulation of the peripheral nervous system within the renal artery. Figure 1

[0064] Figure 3 Figure 3 is a perspective view of a bipolar guide wire according to the present application, intended for a renal or carotid body nerve stimulation assembly.

[0065] Figure 3A Figure 3B Figure 3A and Figure 3B are cross-sectional views on A-A and on B-B, taken respectively from the distal portion and from the proximal portion of the electrically conductive element embedded in the insulating sheath of the bipolar guide wire according to the present application. Figure 3

[0066] Figure 4 Figure 4 shows a cross-sectional view of the composition of the central portion of the bipolar guide wire according to the present application.

[0067] Figure 5A Figure 5B Figure 5C Figure 5D ​​​​​​​​​​​​​​​​​​Figures 5A to 5D is a schematic representation depicting different alternative forms of contact shape of the distal end of an electrical stimulation guidewire according to the application.

[0068]

Figure 6

[0069]

Figure 7

[0070] In the following description and throughout this application, the terms "distal" and "proximal" are used in relation to the patient's body on which the intervention is performed after the renal nerve stimulation or the carotid body nerve stimulation, if applicable. Thus, during the nerve stimulation for diagnostic purposes, the distal end of the guidewire is the end located the furthest in the patient's body.

[0071] It should be noted that the various elements are not necessarily shown to scale.

[0072] Figure 1 and Figure 2 depicts a stimulation assembly according to the application.

[0073] A guide catheter 1 is inserted into the femoral artery.

[0074] Such a guide catheter 1 can be small in diameter. It complies with the standards associated with existing peripheral endovascular catheters. The catheter 1 can comprise a flushing device 10 with a valve, commonly referred to as a "valve" device or a "Y" device, for flushing the inside of the catheter 1 with a suitable flushing liquid or for injecting a contrast agent.

[0075] An electrical stimulation bipolar guidewire 4 is inserted into the sheath of the guide catheter 1. The length of this guidewire 4 is generally between 180 cm and 300 cm.

[0076] Figure 3 、 Figure 3A 、 Figure 3B and Figure 4 The bipolar guidewire 4 is illustrated in detail. It comprises first a metal core 40 in the form of a straight wire extending from a proximal end 41 to a distal end 42.

[0077] The metal wire 40 is coated with an electrically insulating sheath 43 on the central portion between the proximal end 41 and the distal end 42.

[0078] The distal end 42 of the metal core 40 is non-invasive to blood vessels and is configured to be shaped into shape 400, which has at least one point of contact with the blood vessel when the distal end of the conductive core faces a portion of the autonomic nervous system surrounding the blood vessel at its stimulation location.

[0079] The distal end 42 can be a more flexible portion than the rest of the guidewire, its flexibility designed to ensure that shape 400 makes safe contact with the vessel wall. Figure 2 As shown, shape 400 contacts the renal artery AR in order to stimulate the sympathetic nervous system S surrounding AR.

[0080] The metal core 40 is not electrically insulated for the remainder of the wire length.

[0081] The metal layer 44, except for its proximal portion 45 and distal portion 46, is embedded within the electrical insulating sheath 43.

[0082] Therefore, the distal portion 46 is exposed over the entire outer periphery of the insulating sheath 44, such that the distal portion 46 comes into contact with the subcutaneous tissue of the body or with an artery into which the guiding catheter 1 has been inserted.

[0083] The proximal portion 45 is exposed over the entire outer periphery of the insulating sheath 43, making the proximal portion 45 accessible from the outside of the body C when the guidewire is inserted into the insertion sheath of the guiding catheter 1.

[0084] Through this composition of the bipolar guidewire 4, the proximal portion 45 of the integrated conductive element 44, which is composed of metal layers, provides a connection to one electrode of an external electrical pulse stimulator, while the metal core 40 of the bipolar guidewire provides a connection to the other electrode of the external stimulator.

[0085] Therefore, as Figure 1 and Figure 2 As shown, once the bipolar guidewire 4 has been inserted, with the distal end 42 placed in the blood vessels of the renal nervous system, the electrical connection 2 (in particular in the form of an alligator clip) is (especially by clamping) connected to the exposed distal portion 45 of the metal layer 44, and the electrical connection 2 is connected via the power supply wire 30 to an electrode outside the body C, which is typically the anode of the electrical pulse generator 3.

[0086] Another electrode (usually the cathode of the external electrical pulse generator 3 of body C) is connected to another electrical connection 5 via a power supply wire 31. The electrical connection 5 is in particular in the form of an alligator clip, which itself (particularly by clamping) connects to the proximal end 44 of the metal core.

[0087] exist Figure 2 In the illustrated example, contact shape 400 can be a single ring located at the tip of the distal end 42.

[0088] Once deployed, the ring 400 has a generally circular shape centered on the axis of the lead wire, allowing circumferential contact with a blood vessel (in this example, the renal artery) once the lead wire 4 is in its stimulation position. Typically, the diameter of this circular shape 400 can vary from 3 mm to 8 mm.

[0089] The diameter of the lead wire 4 (including its contact shape 400) can be compatible with the inner lumen of the sheath 11 of the guiding catheter, which has a diameter of 1.4 mm (5 French) or 1.8 mm (6 French).

[0090] Neurostimulation of the sympathetic nervous system S via the renal artery AR can be achieved through bipolar electrical stimulation between the cathode of the core electrically connected to the conductor 4 and the anode electrically connected to the exposed portion 45 of the metal layer 44.

[0091] It can be imagined Figures 5A to 5D Various alternative forms illustrated in the figure are used to create a contact shape at the distal end 42 of the conductor 4.

[0092] Figure 5A The contact shape is a loop 400 located at the tip of the distal portion 40 of the guidewire 4. One or more radiopaque markings (gradations) 60 are advantageously embedded in the bottom of the loop 400 of the guidewire 4 for easy identification by angiography.

[0093] Figure 5B The contact shape comprises three adjacent loops 401, 402, and 403 near the straight end of the conductor 40. Transmissive markings 61, 62, and 63 are advantageously embedded in the bottom of each of the three loops 401, 402, and 403. The transmissive markings may be spaced, for example, one every centimeter.

[0094] Figure 5C The contact shape has a single loop 404 near the straight end of the wire 40. One or more non-transmissive markings 64 are advantageously embedded in the bottom of the single loop 404.

[0095] Figure 5C The contact shape, located near the straight end of the conductor 40, has four strands 405 at 90° to each other. At the intersection of these strands 405, a radiopaque marker 65 is advantageously embedded.

[0096] Medical practitioners can, for example, use each of these alternative forms based on the patient's anatomy.

[0097] According to an advantageous embodiment, the electrical stimulation element 4 may include a stimulation marker located at a different position than the distal end 42.

[0098] Such an embodiment is in Figure 6 The diagram shows three markers embedded in the distal end 42 at three locations P1, P2, and P3, spaced at regular intervals. The stimulation clip 5 can be positioned at each of these locations. Therefore, knowing the precise distance between contact shapes 400 to 405 and one of the locations P1 to P3 allows for precise determination of which region of the nervous system S will be stimulated.

[0099] Therefore, by utilizing contact shapes 400 to 405, it is possible to perform an actual mapping of the region of the nervous system S that is sensitive or insensitive to the applied electrical stimulation.

[0100] This makes it possible to know precisely the location of the area that will subsequently be denervated.

[0101] Furthermore, once denervation has been performed, it becomes clear exactly which areas(s) have actually been denervated.

[0102] Methods for renal nerve stimulation and (where applicable) denervation, implemented using the assembly described above, will now be described.

[0103] This method is used when medical professionals wish to perform a diagnosis of the renal artery, especially when denervation is considered.

[0104] Step i / : The medical practitioner inserts the guiding catheter 1 into the femoral artery of the patient's body C.

[0105] Step ii: The medical practitioner then inserts the bipolar guidewire 4 into the insertion sheath of the guiding catheter 1 until the medical practitioner is certain that the distal end 42 and its contact shape 400 are correctly positioned within the renal artery AR to be diagnosed.

[0106] Then the medical personnel make the electrical connection to the external electrical pulse generator 3.

[0107] Step iii: Thus, the nurse or medical practitioner connects one electrode of the external electrical pulse generator 3 to the distal portion 45 of the layer 44 by clamping the connecting clip 2 to the distal portion 45 of the layer 44, and connects the generator's electrode to the proximal end 41 of the metal core by clamping the connecting clip 5 to the proximal end 41 of the metal core.

[0108] Step iv / : Perform direct bipolar stimulation on lead 4. More specifically, lead 4 carries a current in a bipolar mode. The delivered current can be on the order of 15 mA to 25 mA, with a pulse frequency between 200 / min and 2000 / min (10 Hz to 20 Hz), lasting for 1 minute.

[0109] Then, for each region of the nervous system S that is in contact with the contact shapes 400 to 405 of the wire 4, the response to the stimulus is measured.

[0110] The assembly for stimulating the renal nerves (i.e., the sympathetic nervous system around the renal artery) described earlier can also be used to perform renal denervation.

[0111] Specifically, at the end of step iv / , if the nerve region S has been identified as responding significantly to stimulation, then by selecting a guidewire, such as guidewire 4, which also includes a device for transmitting radio frequency signals, ultrasound, or for injecting alcohol, the renal denervation can be performed in step v / without removing any of the components of the assembly.

[0112] The assembly can also be configured to examine denervation procedures, because once such denervation has been performed, monopolar electrical stimulation can be reapplied to each so-called denervated area via contact shapes 400 to 405 to check that the denervation action has been performed properly.

[0113] Using the same components as described and a guiding catheter 1 adapted to the anatomy of the carotid body, along with an electrically stimulating bipolar guidewire 4, can produce... Figure 7 The carotid body nerve stimulation assembly is schematically depicted in the figure.

[0114] Steps i / to iv / remain the same, while contact shapes 400 to 405 contact the carotid body.

[0115] In this application, the stimulation assembly according to the invention can also constitute an assembly for delivering a carotid body angioplasty balloon or stent. Step v / therefore includes delivering a carotid body angioplasty balloon or stent.

[0116] The present invention is not limited to the examples just described; it is worth noting that features of the examples set forth in the unexplained variations can be combined.

[0117] Other variations and modifications may be provided without departing from the scope of the invention.

[0118] Although in the illustrated example, the insertion of the guiding catheter or inserter is performed via the femoral artery route, i.e., inserted into the femoral artery in the groin, it can also be performed via the radial artery route, i.e., inserted into the radial artery in one of the patient's wrists.

[0119] An inserter can be used instead of a guide catheter.

[0120] Although in the illustrated example, two different clips 2 and 5 are used for electrical stimulation, it is also conceivable to have a single clip with two different connecting parts 2 and 5, one for clamping onto the metal core and the other for clamping onto the metal layer.

[0121] Reference List

[0122]

Claims

1. An assembly for transvascular stimulation of a portion of the human autonomic nervous system, comprising: - An inserter or guide catheter (1), including at least one tubular insert sheath (13) intended to be inserted into a blood vessel in the human body. - At least one guidewire (4), referred to as a bipolar guidewire, the guidewire being designed to be inserted into the tubular sheath of the inserter or the guiding catheter, the guidewire (4) comprising a conductive core (40), an electrically insulating sheath (43) coated on a central portion between the proximal end (41) and the distal end (40) of the conductive core, the conductive core being non-electrically insulating for the remainder of the guidewire length, the distal end (40) of the conductive core being non-invasive to blood vessels and configured to have at least one point of contact with the blood vessel when the distal end of the conductive core faces a portion of the autonomic nervous system surrounding the blood vessel at its stimulation location. Shape, the electrically insulating sheath includes a conductive element (44), a distal portion (46) of which is exposed on at least a portion of the outer periphery of the insulating sheath such that the distal portion of the conductive element contacts the blood vessel wall, and a proximal portion (45) of which is exposed on at least a portion of the outer periphery of the insulating sheath such that the guidewire is accessible from outside the body (C) when inserted into the insert sheath, the proximal portion (45) of which provides connection to the electrodes of an external electrical pulse generator, and the conductive core (40) of the bipolar guidewire provides connection to other electrodes of the external electrical pulse generator.

2. The stimulation assembly as claimed in claim 1, wherein the outer diameter of the insulating sheath of the bipolar guidewire is between 0.35 mm and 0.96 mm.

3. In the stimulation assembly as claimed in claim 1 or 2, 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, and the electrode to be connected to the proximal end of the conductive core is a cathode.

4. The stimulation assembly as described in any of the preceding claims, wherein the conductive core is a straight wire and the distal end of the conductive core has a contact shape that extends radially relative to the axial direction of the wire.

5. The stimulation assembly of claim 4, wherein the shape of the contact includes at least one annulus at the end of the conductor or near the straight distal end of the conductor.

6. The stimulation assembly of claim 4, wherein the contact shape comprises at least one loop near the straight distal end of the conductor, preferably at least two adjacent loops.

7. The stimulation assembly of claim 4, wherein the shape of the contact comprises at least one free strand near the straight distal end of the conductor, preferably four strands at 90° to each other.

8. The stimulation assembly as described in any of the preceding claims, wherein the distal end of the conductive core of the bipolar guidewire includes one or more radiopaque markers.

9. The stimulation assembly as described in any of the preceding claims constitutes a transvascular renal nerve stimulation assembly and also constitutes a renal denervation assembly.

10. The stimulation assembly as described in any of the preceding claims constitutes a carotid body stimulation assembly and also constitutes an assembly for delivering a carotid body angioplasty balloon or stent.

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