Assembly for transvascular stimulation of a part of the autonomic nervous system of the human body, in particular for transvascular renal nerve stimulation or for transvascular stimulation of the carotid body - Patent Application 20070233333

Abstract

The present invention relates to an assembly for transvascular stimulation of a part of the autonomic nervous system of the human body, in particular for transvascular renal nerve stimulation or transvascular stimulation of the carotid body. The invention essentially consists of an assembly for monopolar transvascular stimulation from inside an artery, which allows nerve stimulation of a region of the autonomic nervous system around the artery, which stimulation can be either rapid or for mapping purposes.

Description

[Technical field]

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

[0002] Here, and in the context of the present invention, "autonomic nervous system" refers to the nervous system that directs the internal organic functions and does not govern the voluntary mechanisms of the human body, and is therefore different from the somatic system, which concerns the relationship of the body to the outside world. The autonomic nervous system essentially innervates the internal organs, and the sensory neurons of this system convey information about the visceral functions to the central nervous system. Three categories of the autonomic nervous system are usually distinguished: the sympathetic nervous system, the parasympathetic nervous system, and the enteric nervous system.

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

[0004] The present invention first aims to propose a simple and effective solution for transvascular stimulation, in particular for rapid diagnosis and / or mapping of nerve areas, in particular with a view to surgical or percutaneous interventions.

[0005] Although the invention has been described with respect to its use for renal nerve stimulation, it also applies to any other use for stimulation of a part of the autonomic nervous system of the human body, in particular to nerve stimulation of the carotid body. [Background technology]

[0006] Catheter-directed renal sympathetic denervation appears to be promising for the treatment of diseases / dysfunctions, primarily hypertension, but also heart failure, arrhythmias, diabetes, and obstructive sleep apnea.

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

[0008] Although most patients agree to long-term treatment with drugs that are effective in treating their hypertension, the majority are not observed with respect to possible side effects and / or the inability of the drugs to achieve blood pressure goals despite maximal tolerated therapy. In some cases, hypertension is resistant to drug therapy.

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

[0010] Of these, renal sympathetic denervation is the most studied. Renal denervation is a technique that involves superficial stimulation of the afferent and efferent nerves surrounding the renal artery, either using a single-electrode catheter connected to a radiofrequency generator, using a multi-electrode catheter connected to an ultrasound generator, or using a catheter with a needle at its distal end for the injection of an alcohol-based liquid product.

[0011] One of the major challenges with this denervation technique is the lack of markers along the renal artery to pinpoint the exact location of the portion of the nerve that should be destroyed, and therefore to determine the area that should be treated to optimize the effectiveness of the denervation therapy.

[0012] Initial trials using radiofrequency generators for catheter-based renal artery denervation for resistant hypertension have not demonstrated consistent clinical efficacy, widely believed to be due primarily to procedural factors that limit assessment of the completeness of the denervation obtained. [Prior art documents] [Non-patent literature]

[0013] [Non-Patent Document 1] [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. [Non-Patent Document 2] [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.ahajournals.org [Non-Patent Document 3] [3]: Konstantinos P. Tsioufis et al. “Safety and performance of diagnostic electrical mapping of renal nerves in hypertensive patients” EuroIntervention 2018; 14: E1334-e1342 published online September 2018. DOI: 10.4244 / EIJ-D-18-00536

[0014] According to the authors of reference [1], the difficulty in predicting renal denervation and the controversy surrounding the paradigm of renal denervation as an antihypertensive treatment are largely due to the lack of a means to assess denervation during the procedure, i.e., a measurable criterion for confirming the success of the procedure.

[0015] Some authors have The aortorenal ganglion can be localized by a transvascular approach, applying high-frequency monopolar electrical stimulation at 10 Hz with a current of 25 mA to the inferior vena cava or aorta, or to its branches. Stimulation of the aortorenal ganglion induces arterial constriction and a corresponding increase in blood pressure. Renal denervation blocks activation of renal afferent nerves and subsequently abolishes renal vascular responses to aortorenal ganglion stimulation. This shows that.

[0016] Reference [2] (Non-Patent Document 2) refers to electrical stimulation at 20 Hz with 5 ms pulses at a current of 10 mA and makes similar observations.

[0017] On the other hand, the authors of document [3] use a multielectrode catheter sold under the name "Confident™", the distal end of which unfolds into the shape of an ellipse with four branches, each carrying an electrode, when a button on the handle is pressed. This catheter is highly invasive, since its diameter is considerable, about 2.67 mm (8 French), and the authors mention the possibility of nerve mapping using such a catheter, but this remains to be demonstrated, at least considering the unfolded shape, which cannot really be moved within the artery to easily reach other nerve sites. The placement of this catheter is also not easy to perform.

[0018] As such, previously proposed devices can be considered too invasive, are not always reliable for reliable mapping of the renal arteries, and / or are not easy to use.

[0019] Therefore, there is a need for improved renal nerve stimulators to overcome the above drawbacks.

[0020] More generally, there is a need for a medical device that allows neural stimulation of a portion of the autonomic nervous system, which is simple, effective, and non-invasive, particularly for the purpose of mapping or monitoring the effectiveness of denervation. Summary of the Invention [Problem to be solved by the invention]

[0021] It is an object of the present invention to at least partially meet this need. [Means for solving the problem]

[0022] For this reason, the invention relates, according to a first alternative, to a kit for transvascular stimulation of a part of the autonomic nervous system of the human body, comprising: an introducer or guide catheter intended to be introduced into a blood vessel of the human body; a sleeve adapted to be fitted around an introducer or guide catheter, the sleeve being made of an electrically conductive material over at least a portion of its circumference such that when the guide catheter is introduced into a blood vessel, the electrically conductive circumference of the sleeve is in contact with the subcutaneous tissue of the human body or with the wall of the blood vessel, the sleeve additionally being connected to an electrical connection which is itself connected to an electrode of an electrical pulse generator external to the body; An elongated electrical stimulation element intended to be inserted into an introducer or into an introducer sheath of a guide catheter, a conductive distal portion configured to be molded into a shape that is atraumatic to the blood vessel and has at least one contact point with the blood vessel when in its stimulation position facing a portion of the autonomic nervous system around the blood vessel; an electrically insulating central portion; a conductive proximal portion for connecting to the other electrode of the electrical pulse generator so as to provide electrical stimulation through the shaped distal portion; and Includes.

[0023] According to an advantageous configuration, the electrode of the electrical pulse generator which is to be connected to the conductive sleeve fitted around the introducer sheath of the introducer or guide catheter is the anode, while the one which is to be connected to the proximal portion of the elongate element is the cathode.

[0024] According to an advantageous variant, the conductive sleeve consists of one piece made of a conductive material, such as carbon.

[0025] According to this variant, the sleeve preferably consists of a sheath having on its outer periphery a conductive coating, such as a carbon coating.

[0026] According to this variant, the sleeve is preferably elastic so that it can fit over peripheral arterial or venous catheter sheaths of different diameters, usually between 1.6 and 20 mm in outer diameter.

[0027] According to a second alternative, the invention also relates to a kit for transvascular stimulation of a part of the autonomic nervous system of the human body, comprising: an introducer or guide catheter intended to be introduced into a blood vessel of a human body, the introducer or guide catheter comprising at least one tubular introducer sheath and at least one electrically conductive element, a distal portion of the electrically conductive element being exposed over at least a part of the circumference of the sheath so as to contact the subcutaneous tissue of the body or the wall of the blood vessel, a proximal portion of the electrically conductive element being accessible from outside the body (C) and comprising an electrical connection to serve as a connection to an electrode of an electrical pulse generator to the body; An elongated electrical stimulation element intended to be inserted into an introducer or into an introducer sheath of a guide catheter, a conductive distal portion configured to be molded into a shape that is atraumatic to the blood vessel and has at least one contact point with the blood vessel when in its stimulation position facing a portion of the autonomic nervous system around the blood vessel; an electrically insulating central portion; a conductive proximal portion for connecting to the other electrode of the electrical pulse generator so as to provide electrical stimulation through the shaped distal portion; and Includes.

[0028] According to an advantageous configuration, the electrode of the electrical pulse generator which is to be connected to the introducer or to the guide catheter is the anode, while the one which is to be connected to the proximal part of the elongate element is the cathode.

[0029] According to an advantageous variant, the conductive element of the introducer or of the guide catheter is a wire or metal strip housed at least partially within the thickness of the sheath and with a distal part exposed at the outer periphery of the sheath.

[0030] Preferably, the cross-sectional area of ​​the wire or of the metal strip is between 0.25 and 5 mm 2 Between.

[0031] According to a first advantageous embodiment, the elongate element is a straight wire, the distal portion of which comprises a contact feature, the contact feature extending radially along the axis of the wire.

[0032] Several advantageous alternatives for generating the contact geometry are possible.

[0033] Therefore, the contact shape is At least one loop at or near the end of the wire; At least one ring, preferably at least two adjacent rings, adjacent the straight end of the wire; At least one free strand near the straight end of the wire, preferably four strands at 90° to each other; may include.

[0034] According to a second advantageous embodiment, the elongated element comprises a guidewire and a tube made of a shape memory alloy arranged around and temporarily attached to the guidewire, such that when the distal portion of the guidewire reaches its stimulation position, the guidewire is withdrawn towards the outside of the body, thereby causing the distal portion of the tube to assume the contact shape.

[0035] Preferably, the contact shape of the distal portion of the tube is helical.

[0036] According to an advantageous variant embodiment, the distal portion of the elongate element comprises one or more radiopaque markers.

[0037] The kit may be a kit for transvascular renal nerve stimulation or even a renal denervation kit.

[0038] This could also be a kit for stimulation of the carotid body, or even a kit for delivery of a stent or balloon for dilating the carotid artery.

[0039] The invention also relates to a method for neurostimulation of a part of a patient's autonomic nervous system, and, if necessary, for surgical intervention, which comprises the following steps: i / Fitting a sleeve around the guide or introducer catheter, the sleeve being made of a conductive material over at least a portion of its circumference and further including an electrical connection to an electrode of an electrical pulse generator external to the body; ii / introducing a guide catheter or introducer into the femoral or radial artery of the body so that the conductive outer periphery of the sleeve is in contact with the subcutaneous tissue of the body or with the wall of the artery or vein; iii / introducing a wire into an introducer sheath of a guide catheter or of an introducer, the wire being a conductive distal portion configured to be molded into a shape that is atraumatic to the blood vessel and has at least one contact point with the blood vessel when in its stimulation position facing a portion of the autonomic nervous system around the blood vessel; an electrically insulating central portion; a conductive proximal portion that functions to connect to the other electrode of the electrical pulse generator so as to provide electrical stimulation through the shaped distal portion; and performing monopolar nerve stimulation directly on the wire via an iv / external electrical pulse generator; v / if necessary, surgically intervene in one or more areas stimulated according to step iv / ; Includes.

[0040] Thus, the invention consists of a kit for monopolar transvascular stimulation from within an artery, which allows neural stimulation of the region of the autonomic nervous system surrounding the artery, which stimulation can be either rapid or for mapping purposes.

[0041] This nerve stimulation can in particular be a transvascular (arterial or venous) renal stimulation of areas of the sympathetic nervous system that may cause arterial hypertension, so that it is possible to perfectly localize and denervate nerve areas in order to reduce or eliminate hypertension. This stimulation also makes it possible to check the effect of a previously performed denervation.

[0042] This also involves transvascular (arterial or venous) stimulation of the carotid body. By performing a rapid stimulation, it is possible to observe the temporary hypotension and / or bradycardia (slowing of the heart rate) induced. This makes it possible to predict bradycardia or arterial hypotension before carotid angioplasty and therefore to be able to administer drugs to anticipate it and avoid this risk.

[0043] The guide catheter or introducer of the stimulation kit according to the invention may be entirely conventional with respect to the vascular anatomy to be diagnosed.

[0044] The electrical stimulation element, in particular a simple wire whose proximal and distal portions are conductive, has an atraumatic contact geometry that contacts a specific area of ​​the blood vessel (artery or vein) around the vessel and facing the end of the nervous system to be stimulated.

[0045] In addition, the required intensity of the nerve stimulation is low: typically, the intensity of the delivered alternating current may range from 10 to 25 mA for approximately 10 to 60 seconds, with a frequency ranging from 200 to 800 / min (10 to 20 Hz).

[0046] All parts of the kit are easy to handle, allowing the operating surgeon to simply connect an electrode of the electrical pulse generator, usually the anode, to the conductive sleeve fitted around the catheter guide and then connect the other electrode, usually the cathode, to the electrical stimulation wire in the usual manner.

[0047] In summary, the advantages of transvascular nerve stimulation kits for diagnostic purposes are numerous, among which are: Medical equipment that is easy to install, A reliable transvascular neurostimulator that allows for highly accurate mapping of neural territories of the patient's autonomic nervous system; A device that allows mapping before denervation or carotid artery treatment procedures, as well as checking their effects during and after said interventions; the possibility of implementation on any existing guide catheter, since all that is required is to fit a conductive sleeve around this catheter before introducing it into the vein or artery to be stimulated, and to make an electrical connection to a wire inserted in the catheter; the possibility of using thinner, less invasive catheters, especially upstream of possible surgical procedures, typically with a diameter of 6 French rather than 8 French as in prior art devices; the possibility of using wires or guides familiar to the cardiologist or surgeon; The following can be mentioned.

[0048] The only relevant limitation of the sleeve is at the start of the intervention in preparation, in fitting the sleeve around the introducer sheath of the guide catheter or introducer.

[0049] However, this procedure is very simple and easy to perform and can be carried out by an assistant or nurse who does not need to have any special skills for this task.

[0050] Further advantages and features will appear more clearly on reading the detailed description given by way of non-limiting example with reference to the following figures. [Brief description of the drawings]

[0051] [Figure 1] FIG. 2 is a schematic diagram illustrating the use of a renal nerve stimulation kit according to the present invention comprising a guide catheter and a stimulation sleeve according to the present invention, the guide catheter being introduced directly into a peripheral artery of a patient. [Diagram 2] FIG. 2 shows the configuration of the electrical stimulation wire of the kit according to FIG. 1 in the renal artery for neurostimulation of the surrounding nervous system. [Diagram 3] FIG. 3 is a perspective view of a conductive sleeve according to the present invention, intended to be fitted around a guide catheter such as that shown in FIGS. 1 and 2. [Figure 4] FIG. 4 is a partial longitudinal cross-sectional view showing the sleeve of FIG. 3 fitted around a guide catheter. [Figure 5A] 1A-1C are schematic diagrams illustrating various alternative embodiments of contact geometries at the distal ends of electrical stimulation wires according to the present invention. [Figure 5B] 1A-1C are schematic diagrams illustrating various alternative embodiments of contact geometries at the distal ends of electrical stimulation wires according to the present invention. [Figure 5C] 1A-1C are schematic diagrams illustrating various alternative embodiments of contact geometries at the distal ends of electrical stimulation wires according to the present invention. [Figure 5D] 1A-1C are schematic diagrams illustrating various alternative embodiments of contact geometries at the distal ends of electrical stimulation wires according to the present invention. [Figure 6] 13A-13C show schematic diagrams of another variant embodiment of a wire with an electrical stimulation tube according to the invention before and after deployment of the tube. [Figure 7] 1A-1C are schematic diagrams illustrating different electrical stimulation locations for mapping the renal nervous system around the renal arteries of a patient. [Figure 8] FIG. 1 is a schematic diagram showing the use of a carotid nerve stimulation kit according to the present invention comprising a guide catheter and a stimulation sleeve according to the present invention, the guide catheter being introduced directly into a peripheral artery of a patient. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] In the following description, and throughout this application, the terms "distal" and "proximal" are used relative to the patient's body where renal or carotid nerve stimulation, if any, is followed by an intervention. Thus, the distal end of the wire is the end that is located furthest inside the patient during diagnostic nerve stimulation.

[0053] It will be noted that the various elements are not necessarily shown to scale.

[0054] 1 and 2 show a diagnostic kit according to the present invention.

[0055] A guide catheter 1 is introduced into the femoral artery.

[0056] Such a guide catheter 1 can be of small diameter, conforming to existing peripheral intravascular catheter standards. The catheter 1 can include a flushing device 10 with a stopcock, commonly called a "valve" or "Y-piece", for flushing the inside of the catheter 1 with a suitable flushing solution or for injecting a contrast agent.

[0057] An electrically conductive sleeve 2 is fitted directly around the introducer or guide catheter 1. The sleeve 2 is connected to an electrical connection 20 which is itself connected by an electrical supply wire 30 to an electrode, usually the anode of an electrical pulse generator 3, external to the body C.

[0058] An electrical stimulation wire 4 is introduced into the sheath 11 of the guide catheter 1. The length of this wire 4 is typically between 180 and 300 cm.

[0059] As shown in FIG. 2, the wire 4 includes a conductive distal portion 40 configured to be shaped according to a shape 400 that is atraumatic to the renal arteries and has at least one contact point with the renal arteries to stimulate the sympathetic nervous system S surrounding the renal arteries.

[0060] In the example shown in FIG. 2, the contact feature 400 may be a single loop, which may be located at the end of the proximal portion.

[0061] When deployed, this loop 400 has a substantially circular shape centered on the axis of the wire, which allows circumferential contact with the blood vessel, here the renal artery, when the wire 4 is in its stimulation position. Typically, the diameter of this circle 400 varies from 3 to 8 mm.

[0062] A central portion of the wire 4, at least the portion adjacent the contact feature 400 toward the proximal portion 41 of the wire 4, is electrically insulated to prevent conduction of the stimulation current to the vessel wall.

[0063] The proximal portion 41 of the wire is electrically conductive and serves as the connection to the other electrode, typically the cathode of the external electrical generator 3 .

[0064] To ensure the electrical connection, an alligator clip 5 is secured by clamping the proximal portion 41 of the wire 4. This clip 5 is connected to the anode of the electrical generator 3 by an electrical supply wire 31.

[0065] The diameter of the wire 4, including its contact geometry 400, can be adapted to fit within the lumen of a guide catheter sheath 11 having a diameter of 1.4 mm (5 French) or 1.8 mm (6 French).

[0066] A sleeve 2 according to the invention is shown in Figure 3. It is in the form of a tube, at least part of its circumference being electrically conductive.

[0067] This conductive portion is connected to an electrical connection 20, usually in the form of a connector, by means of an electrical supply wire 21. The sleeve 2, the connector 20 and the electrical supply wire 21 can advantageously constitute a kit for being fitted around the catheter 1 and connected to an electrode of an electrical generator 3.

[0068] The sleeve 2 may be cylindrical or frusto-conical in shape, the shape of which conforms as closely as possible to the outer shape of the introducer sheath of the guide catheter 1.

[0069] The sleeve 2 may include an integrated flushing device 22 with a stopcock, commonly called a "flush", for flushing the inside of the catheter or of the introducer 1 with a suitable flushing liquid.

[0070] As can be seen in FIG. 4, the thickness of this sleeve 2 is typically on the order of one millimeter or less and adds only a small extra thickness to the sheath 11 of the introducer or guide catheter 1 and therefore does not impede its advancement during its introduction into the peripheral artery V.

[0071] The sleeve 2 can be in the form of a completely electrically conductive one-piece part or in the form of a part covered with an electrically conductive coating. Carbon can be advantageously chosen as the electrically conductive material.

[0072] According to an advantageous variant, the sleeve 2 can be designed so that it is elastic and can therefore adapt to any existing size of peripheral arterial catheters.

[0073] In practice, as described below, a surgeon or interventionalist who wants to perform renal nerve stimulation (Figure 1) or carotid nerve stimulation (Figure 8) begins by placing a conductive sleeve 2 around an introducer or guide catheter 1. Since the placement of the conductive sleeve is very simple and easy, this can be done by an assistant or nurse without the need to adopt any special techniques.

[0074] Deployment is achieved when the sleeve 2 is placed and positioned around the introducer sheath of the guide catheter 1 so that the sleeve 2 contacts either the patient's subcutaneous area or the wall of the patient's peripheral artery or vein.

[0075] Once this arrangement has been performed, the electrical connection 20 can be directly connected to the anode of the external cardiac stimulator 3 by means of a connecting wire 30 .

[0076] A clip 5, typically an alligator clip 5, can then be secured by clamping a proximal portion 41 of a wire 4 inserted into a sheath 11 of the peripheral catheter 1. The clip 5 is connected to the cathode of an external electrical generator 3 by a connecting wire 31.

[0077] In this manner, neural stimulation of the sympathetic nervous system S through the renal artery AR can be achieved by monopolar electrical stimulation between a cathode electrically connected to the wire 4 around the guide catheter 1 and an anode electrically connected to the sleeve 2 according to the present invention.

[0078] To create contact geometries at the distal portion 40 of the wire 4, various alternatives can be provided, as shown in Figures 5A to 5D.

[0079] 5A relates to a contact geometry that is a loop 400 at the end of the distal portion 40 of the wire 4. One or more radiopaque markers (gradations) 60 are advantageously embedded in the wire 4 at the base of the loop 400 to facilitate angiographic identification.

[0080] 5B relates to a contact geometry that includes three adjacent rings 401, 402, 403 near the straight end of the wire 4. Radiopaque markers 61, 62, 63 are advantageously embedded in the base of each of these three rings 401, 402, 403. The radiopaque markers may be spaced, for example, one centimeter apart.

[0081] 5C relates to a contact configuration with a single ring 404 near the straight end of the wire 4. One or more radiopaque markers 64 are advantageously embedded at the base of the single ring 404.

[0082] 5D relates to a contact configuration with four strands 405 at 90° to each other, close to the straight end of the wire 4. Radiopaque markers 65 are advantageously embedded at the junctions of these strands 405.

[0083] Each of these variations may be used by the practitioner depending on, for example, the patient's anatomy.

[0084] An alternative embodiment of the electrical stimulation element instead of a single wire 4 is shown in FIG.

[0085] In this alternative, the electrical stimulation element 4 includes a guidewire 42 and a tube 43 made of a shape memory alloy, preferably Nitinol, disposed around and temporarily secured to the guidewire 42 .

[0086] Once the distal portion 40 reaches its stimulation location (top view of FIG. 6), the guide wire 42 is pulled outward toward the outside of the body, causing the distal portion of the tube 43 to assume a contact shape 430 (bottom view of FIG. 6).

[0087] In the illustrated example, the contact shape 430 is a spiral shape that extends along the sympathetic nervous system S and inside the renal arteries (RA).

[0088] The diameter of the guidewire 42 can be, for example, 0.014 inches or 0.018 inches, which corresponds to the usual diameters already available on the market and which make it possible to deliver stents, balloons or other stimulation or denervation devices in the renal or carotid arteries, whether using radiofrequency techniques, ultrasound or the injection of alcohol.

[0089] According to an advantageous embodiment, the electrical stimulation element 4 may include stimulation markers arranged at different positions on the proximal portion 41 .

[0090] One such embodiment is shown in Figure 7. Three markers are embedded in the proximal portion 41 at three regularly spaced locations P1, P2, P3 at which a stimulation clip 5 can be placed. Thus, knowing the exact distance between the contact shapes 400 to 405 and one of the locations P1 to P3, it is possible to know exactly which area of ​​the nervous system S is to be stimulated.

[0091] It is therefore possible to perform a true mapping of areas of the nervous system S that may or may not be sensitive to electrical stimulation performed with contact shapes 400 to 405.

[0092] This may allow for precise location of the area to be subsequently denervated.

[0093] Then, once the denervation procedure has been performed, the area that has been effectively denervated is precisely observed.

[0094] We now describe the method of renal nerve stimulation, and where appropriate, denervation, performed by the above-mentioned kit.

[0095] This method is applicable when the practitioner wishes to perform diagnostics on the renal arteries, particularly for the purpose of denervation.

[0096] Step i / : The nurse or practitioner proceeds to place the conductive sleeve 2 around the guide catheter 1.

[0097] Step ii / : The practitioner then introduces the guide catheter 1 into the femoral artery of the body C, so that the conductive periphery of the sleeve 2 comes into contact with the subcutaneous tissue of the body or with the wall of the artery or vein.

[0098] Step iii / : The practitioner then introduces the wire 4 into the introducer sheath 11 of the guide catheter 1 until it is confirmed that the distal portion 40 with its contact shape 400 is correctly positioned in the renal artery AR to be diagnosed.

[0099] The practitioner can then proceed with the electrical connection to the external electrical generator 3 .

[0100] Thus, the nurse or practitioner connects, on the one hand, the sleeve 2 to an electrode, typically the anode of an external cardiac stimulator 3 , and, on the other hand, the proximal part 41 of the wire 4 to the other electrode of the external generator 3 .

[0101] Step iv / : A monopolar stimulation is performed directly on the wire 4. More precisely, the wire 4 conducts current in monopolar mode. The current delivered can be of the order of 15 mA to 25 mA at a frequency between 200 and 800 / min for 1 min (10 to 20 Hz).

[0102] The response to this monopolar stimulation is then measured for each region of the nervous system S facing the area in contact with the contact configurations 400 to 405 of the wire 4 .

[0103] Renal denervation can also be performed using the renal nerve stimulation kit just described, i.e., for stimulation of the sympathetic nervous system around the renal arteries.

[0104] Indeed, at the end of step iv / , once it has been established that the nerve area S responds significantly to stimulation, it is possible to carry out renal denervation according to step v / , without removing any of the parts of the kit, by selecting a guidewire, for example a guidewire 42, which also incorporates a device for emitting high-frequency signals, ultrasound or for injecting alcohol.

[0105] This kit also constitutes a denervation control kit, since once denervation has been performed, it is possible to perform again, by means of the contact shapes 400 to 405, a monopolar electrical stimulation of each area supposed to be denervated in order to verify that the denervation operation has actually been performed.

[0106] With the same components as described, together with a guide catheter 1 and an electrical stimulation element 4 adapted to the carotid organ, it is possible to manufacture a carotid nerve stimulation kit as shown diagrammatically in FIG.

[0107] Steps i / through iv / remain the same, with contact shapes 400 through 405 contacting the carotid body.

[0108] In this use, the stimulation kit according to the invention may also constitute a kit for the delivery of a carotid artery dilatation stent or balloon. Step v / therefore consists in delivering a carotid artery dilatation stent or balloon.

[0109] The invention is not limited to the examples just described, and in particular the features of the illustrated examples can be combined with one another in alternatives not shown.

[0110] Other alternatives and modifications can be envisaged without thereby departing from the scope of the invention.

[0111] In the illustrated example, introduction of the guide catheter or introducer is via the femoral route, i.e., into the femoral artery in the groin, but it could also be via the radial route, i.e., into the radial artery in the patient's wrist.

[0112] Instead of a guide catheter, an introducer can be used. [Explanation of symbols]

[0113] 1 Guide Catheter 2 Conductive sleeve 3 Electrical Pulse Generator 4 Electrical Stimulation Wires 5 Alligator Clips 10 Cleaning equipment 11 Sheath 20 Electrical Connections 21 Electrical supply wire 22 Cleaning Equipment 30 Electrical supply wire 31 Electrical supply wire 40 Distal part 400 to 405 Contact Shape 41 Proximal part 60 Radiopaque Markers 61 Radiopaque Markers 62 Radiopaque Markers 63 Radiopaque Markers 64 Radiopaque Markers 42 Guidewire 43 Tube 430 Contact shape

Claims

1. 1. A kit for transvascular stimulation of a portion of the autonomic nervous system of a human body, comprising: an introducer or guide catheter (1) intended to be introduced into a blood vessel of the body; a sleeve (2) adapted to be fitted around said introducer or guide catheter, said sleeve being made of an electrically conductive material over at least a part of its circumference, such that when said guide catheter is introduced into said blood vessel, said electrically conductive circumference of said sleeve is in contact with the subcutaneous tissue of said body or with the wall of said blood vessel, said sleeve being additionally connected to an electrical connection which is itself connected to an electrode of an electrical pulse generator (3) external to said body; an elongated electrical stimulation element (4) intended to be inserted into the introducer or into an introducer sheath (11) of the guide catheter, a conductive distal portion (40) configured to be shaped to be atraumatic to the blood vessel and to have at least one contact point with the blood vessel when in its stimulation position facing the portion of the autonomic nervous system around the blood vessel; an electrically insulating central portion; a conductive proximal portion (41) that serves to connect to the other electrode of the electrical pulse generator so as to provide electrical stimulation through the shaped distal portion; and Including the kit.

2. 2. The stimulation kit of claim 1, wherein the electrode of the electrical pulse generator connected to the conductive sleeve fitted around the introducer sheath of the introducer or guide catheter is an anode, while the one connected to the proximal portion of the elongate element is a cathode.

3. 3. The stimulation kit of claim 1, wherein the conductive sleeve is constructed as a single piece made of a conductive material such as carbon.

4. 4. The stimulation kit of claim 3, wherein the sleeve is comprised of a sheath having a conductive coating, such as a carbon coating, on its outer periphery.

5. 5. The stimulation kit of claim 3 or 4, wherein the sleeve is elastic so that it can fit over peripheral arterial or venous catheter sheaths of different diameters, typically between 1.6 and 20 mm in outer diameter.

6. 1. A kit for transvascular stimulation of a portion of the autonomic nervous system of a human body, comprising: an introducer or guide catheter intended to be introduced into a blood vessel of the human body, the introducer or guide catheter comprising at least one tubular introducer sheath and at least one electrically conductive element, a distal portion of the electrically conductive element being exposed over at least a part of the circumference of the sheath so as to contact the subcutaneous tissue of the body or the wall of the blood vessel, a proximal portion of the electrically conductive element being accessible from outside the body (C) and comprising an electrical connection to serve as a connection to an electrode of an electrical pulse generator to the body; an elongated electrical stimulation element (4) intended to be inserted into the introducer or into the introducer sheath of the guide catheter, a conductive distal portion configured to be shaped (400) to be atraumatic to the blood vessel and to have at least one contact point with the blood vessel when in its stimulation position facing the portion of the autonomic nervous system around the blood vessel; an electrically insulating central portion; a conductive proximal portion for connecting to the other electrode of the electrical pulse generator to provide electrical stimulation through the shaped distal portion; and Including the kit.

7. 7. The stimulation kit of claim 6, wherein the electrode of the electrical pulse generator connected to the introducer or to the guide catheter is an anode, while the one connected to the proximal portion of the elongate element is a cathode.

8. 8. The stimulation kit of claim 6, wherein the conductive element of the introducer or of the guide catheter is a wire or metal strip that is at least partially contained within the thickness of the sheath and has a distal portion exposed at the outer periphery of the sheath.

9. The cross section of said wire or of said metal strip is between 0.25 and 5 mm 2 The stimulation kit of claim 8, wherein

10. 10. The stimulation kit of claim 1, wherein the elongated element is a straight wire, a distal portion of the straight wire including contact features, the contact features extending radially along an axis of the wire.

11. 11. The stimulation kit of claim 10, wherein the contact feature comprises at least one loop (400) at an end of the wire or near a straight end of the wire.

12. 11. The stimulation kit of claim 10, wherein the contact geometry comprises at least one ring (401, 402, 403) near the straight end of the wire, preferably at least two adjacent rings.

13. 11. The stimulation kit of claim 10, wherein the contact geometry comprises at least one free strand (405) near the straight end of the wire, preferably four strands at 90° to each other.

14. 10. The stimulation kit of claim 1, wherein the elongated element comprises a guidewire (42) and a tube (43) made of a shape memory alloy arranged around and temporarily attached to the guidewire, such that when a distal portion of the guidewire reaches its stimulation position, the guidewire is withdrawn towards the outside of the body, thereby causing the distal portion of the tube to assume the contact shape.

15. 15. The stimulation kit of claim 14, wherein the contact shape of the distal portion of the tube is a spiral shape (430).

16. 16. The stimulation kit of any one of claims 1 to 15, wherein the distal portion of the elongate element comprises one or more radiopaque markers (60, 61, 62, 63, 64, 65).

17. 17. A stimulation kit according to any one of claims 1 to 16, which is a kit for transvascular renal nerve stimulation, further a renal denervation kit.

18. 18. A stimulation kit according to any one of claims 1 to 17, which is a kit for stimulation of the carotid body and also for delivery of a stent or balloon for carotid artery dilation.

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