WO2019185880A1

WO2019185880A1 - Assembly for placement of a cardiac, aortic or arterial implant with stimulation assistance by a peripheral venous or arterial catheter

Info

Publication number: WO2019185880A1
Application number: PCT/EP2019/058038
Authority: WO
Inventors: Benjamin FAURIE
Original assignee: Electroducer
Priority date: 2018-03-29
Filing date: 2019-03-29
Publication date: 2019-10-03

Abstract

The present invention relates to an assembly for the placement of a cardiac, aortic or arterial implant, comprising an insertion sheath (13) for an introducer (1) or a delivery catheter (1'), which is smaller than that of an introducer intended to be inserted into an artery of a human body. The invention essentially consists of the integration of the metal support of an electrode of the external pacemaker into the insertion sheath of a peripheral venous, arterial or accessory catheter, or a sleeve around the accessory catheter, which is inserted into the peripheral vein or artery of a patient. The sheath of the accessory catheter or the sleeve according to the invention is therefore directly in contact with a peripheral vein or artery of the patient.

Description

ASSEMBLY FOR INSTALLING A CARDIAC, AORTIC OR ARTERIAL IMPLANT WITH CATHETER STIMULATION ASSISTANCE FOR PERIPHERAL ARTERIAL OR VENOUS PATHWAY

Technical area

The present invention relates to a delivery assembly for a cardiac, aortic or arterial implant.

By "cardiac or aortic implant" is meant here and in the context of the invention, a prosthetic aortic or cardiac valve for replacing a native valve.

A preferred application is the replacement of a cardiac valve percutaneously, comprising a valve delivery catheter and optionally an introducer, commonly called "introducer".

A percutaneous heart valve replacement operation is commonly known by the acronym TAVI for "Transcatheter Aortic Valve Replacement".

Although described with reference to the replacement of an aortic valve, the assembly according to the invention can equally well be applied for the replacement of another valve of the heart, such as the triscupid valve or the mitral valve.

By "arterial implant" is meant here and in the context of the invention, a prosthetic device which can be a support (balloon, stent) intended to be implanted in an artery of a human being to repair (dilate, repair) open) a damaged artery.

The invention is applicable to all types of peripheral vascular interventions, on the peripheral arteries, such as carotid arteries, aortas, including the thoracic aortic stent delivery operations (TEVAR acronym for "Thoracic Endovascular"). Aortic Repair "), carotid stents for people suffering from a narrowing of these arteries (CAS acronym for" Carotid Artery Stenting "). These may be cardiac or peripheral pediatric procedures, particularly in the case of congenital heart disease.

The present invention relates more particularly to the improvement of cardiac pacemaker implantation assistance by means of a pacemaker in order to stabilize, secure and optimize the placement accuracy of the various devices such as stents, balloons or other prostheses. In general, the introducer and / or the delivery catheter of the assembly according to the invention can be implanted percutaneously in a patient, and more specifically, trans-femoral, trans-aortic way. carotid or subclavian, or in peripheral arteries such as radial or ulnar arteries.

State of the art

A widely known cardiac disease is that related to the calcification narrowing of the cardiac aortic valve, the latter being the valve that separates a cardiac cavity, namely the left ventricle of the aorta and which allows in the open position to let the blood pass through. heart to the rest of the body of a human being.

A tight or very tight narrowing prevents the aortic valve from opening normally and therefore generates the disease also known as calcified aortic stenosis.

Treatment for this condition involves replacing the defective heart aortic valve.

Replacement of a defective cardiac aortic valve is most commonly performed by opening the chest, placing the patient under cardiopulmonary bypass, temporary cardiac arrest, and opening the heart, for excision and replacement of the native valve by an artificial valve or prosthesis.

These successive stages of the operation have the major drawbacks of involving a relatively long hospitalization of the patient, of being complex and expensive and of being reserved for only a portion of the patients affected, because in many cases the (s) doctor (s) and / or surgeon (s) consider that surgery called "open-heart" can not be practiced because too risky given the general condition of the patient, especially because of the judgment of the necessary heart and the extracorporeal circulation afferent.

To remedy this drawback, it has been envisaged to replace a heart valve by minimally invasive means but still under cardiopulmonary bypass. International patent applications WO 93/01768 and WO 97/28807, as well as US patents US 5814097, US Pat. No. 5,370,685 or US Pat. No. 5,545,214, which illustrate known minimally invasive techniques as well as instruments for implementing these techniques, may be cited here. .

The existing techniques, however, were considered not to be perfectly satisfactory and as likely to be improved.

In particular, these techniques have the following major drawbacks: - to impose in any event the placing of the patient under extracorporeal circulation; they are difficult to put into practice;

- Not to allow a precise control of the diameter according to which the native valve is cut, for subsequent calibration of the prosthetic valve;

- to cause risks of diffusion of fragments of native valve, often calcified, in the body, which can lead to an embolism,

- risk of perforation of the aortic or cardiac wall;

- the risk of acute reflux of blood during the removal of the native valve.

To overcome the shortcomings of these techniques, one approach has been the establishment of artificial aortic valves, called percutaneous, which is inspired by the techniques of endovascular treatment by introduction of a catheter inside a blood vessel, such as the aorta.

Thus, the native cardiac aortic valve which is deficient by calcification is replaced by an artificial valve avoiding the usual intervention of heavy cardiac surgery as mentioned above.

The establishment of an artificial valve can currently be performed by different percutaneous routes: trans-femoral, that is to say by introduction from the femoral artery to the heart or trans-apical, or trans-aortic, or carotid or subclavian, that is to say any path not requiring open-heart surgery through an opening of the chest or extracorporeal circulation.

The operation itself consists in depositing an artificial valve (prosthesis), which reproduces the general form of a normal native aortic valve, at the calcified native aortic valve (diseased), the latter being left in place and crushed by the prosthesis.

To do this, the artificial valve made in pericardium, a thin membrane surrounding the heart, of porcine or bovine origin, is fixed beforehand inside a tubular metallic mesh expandable radially ("stent" in English) and constituted by assembly wire made of shape memory material, for example nickel-titanium alloy or cobalt-chromium, 316L stainless steel for coronary stents.

Then the valve-mesh assembly is compressed at the end of a tubular sheath, called delivery catheter, which can be introduced either directly into an artery, or to inside an introducer allowing access to the artery while maintaining hemostasis.

An interventionist doctor then slides the valve-mesh assembly into the introducer or directly into the delivery catheter, until said assembly reaches the aortic valve ill. The valve-mesh assembly is then deposited at the level of the sick valve by dilation of a balloon before placement.

There are also valve delivery catheters comprising a valve-grill assembly without balloon in which the valve is self-expanding which allows a deposit of the valve which expands radially by simply removing the sheath which surrounds it and therefore without have to dilate a balloon beforehand.

For more information, reference may be made to US Pat. Nos. 7018,406, 7892281, US8652202 and US Pat. No. 8747459.

During proper placement it is necessary for a short period of time to perform a temporary cardiac arrest by rapid ventricular pacing to minimize transvalvular flow, i.e. between valves, and to at least minimize potential embolization.

This temporary heart failure, also commonly known as "cardiac stun", consists in deliberately beating the heart at 150 to 200 beats per minute so that there is no more effective contraction, which causes a drop in pressure and simulates ventricular tachycardia or fibrillation and therefore stabilization of the heart.

This stabilization of the core allows the stabilization of the balloon and thus increase the accuracy of the installation of the artificial valve in a few seconds.

There are bipolar stimulation catheters, with two electrodes, called training probes or electro-systolic stimulation, for the temporary endocardial stimulation of the right ventricle.

These electro-systolic stimulation probes have a number of detailed disadvantages as follows.

First of all, such a probe constitutes a central venous approach with a risk of vascular complication added to the targeted patient population that is fragile. The French registry designates "France 2" which lists the aortic valve replacement interventions, commonly referred to by the acronym TAVI for "Transcatheter Aortic Valve Implantation", indicated as a result a risk of complications rate. vascular importance equal to 4.7%. This result is reported on page 1709 of the publication

[1].

Then, this probe is relatively rigid, and therefore its placement in the right ventricle which is fragile and whose wall is thinner than that of the left ventricle, induces a consequent risk of the phenomenon well known to interventionist physicians under the term "Tamponade", which represents a significant circulatory insufficiency that can even lead to the patient's mortality.

It should be noted, moreover, that this risk exists both during the intervention, that is to say during the placement of the electro-systolic probe but also postoperatively because of the mobilization of patients in their bed and therefore the probe still present which can then pierce the wall of the right ventricle.

In addition, there is a risk of displacement of the electro-systolic stimulation probe during the crucial moment of the placement of the valve. Indeed, a stimulation probe is not fixed in a wall of the heart and can therefore move and thus cause a loss of capture of the electrical stimulation signal.

The heart is then no longer stimulated and therefore has significant movements that hinder the placement of the valve or the balloon.

Another risk associated with the use of such probes is the risk of infection at the puncture site. The France 2 register indicated a rate of less than 1%: see publication [1]

Finally, an interventionist physician considers as significant the additional operating time associated with the establishment of a temporary stimulation probe, which is an operation not always easy to perform.

The publication [2] highlights the advantages of achieving this ventricular pacing on the left ventricle and not on the right ventricle and not doing so by means of a specific transvenous stimulation catheter, but by implementing an external pacemaker with the wire guide used for procedures of this type.

Thus, the recommended implementation described in this publication [2] is to use the wire guide supporting the expansion balloon of the stent and introduced into the left ventricle, as a portion connected to the cathode a pacemaker and a cutaneous electrode or needle implanted in the subcutaneous tissue, as a support for the anode of the pacemaker. The publications [3] and [4] validate in the case of a coronary angioplasty intervention on a pig population, the effectiveness of a temporary cardiac stimulation with a lower stimulation electrical voltage, by the implementation of the supporting wire guide. the stent expansion balloon, as part connected to the cathode of a pacemaker and a cutaneous electrode or needle implanted in the subcutaneous tissue, as a support for the anode of the pacemaker.

Thus, these recommended implementations have the advantages of avoiding having to implant a dedicated additional catheter, to avoid additional access to the heart, to reduce the time and cost of the operation, but also to reduce the rate. complications related to the implantation of the dedicated catheter, while allowing stimulation as effective as through a transvenous stimulation.

In addition, compared to electro-systolic stimulation probes of the right ventricle which induce the risk of tamponade as explained above, the wire guide used for this technique is very stable and comes in permanent support against the wall of the left ventricle relatively thick since it serves as a rail for advancing the stent-balloon-valve assembly through the valve.

However, this technique still requires the establishment of an electrode or an additional subcutaneous needle which must be precise, the establishment and maintenance of connecting tongs, crocodile type on two distant supports .

The inventor of the present invention has filed patent application WO2016 / 162315 A1 which describes and claims the integration of an electrode of a pacemaker directly into the introducer sheath (introducer or delivery catheter) in the artery of a patient. The proposed invention makes it easier and faster to set up and manipulate pacemaker electrodes for the surgeon (s) in charge of the operation.

The disadvantage of this application is that it requires the realization of introducers or specific delivery catheters.

However, it would be interesting to have one or more solutions that allow (s) to keep introducers or existing catheters, that is to say those that do not have an integrated electrode within them.

More generally, it would be interesting for the chosen solution (s) to apply not only to cardiac or aortic valve replacement operations. but also to all implantation operations during peripheral vascular interventions.

The object of the invention is to respond at least in part to this (these) need (s).

Presentation of the invention

To this end, the subject of the invention is, according to a first alternative, a set of replacement of a cardiac valve percutaneously, comprising:

a device forming an introducer or a valve delivery catheter comprising at least one tubular introducer sheath, intended to be introduced into an artery of a human body and, if necessary, to allow a surgical intervention device to pass through,

an accessory catheter intended to be introduced into an artery or a peripheral vein of the human body;

a sleeve adapted to be fitted around the accessory catheter, the sleeve being made of electrically conductive material on at least a part of its outer periphery so that when the accessory catheter is introduced into the artery or into the peripheral vein of the human body, the conductive periphery of the sleeve is in contact with the subcutaneous tissue of the body or with the wall of the artery or vein, the sleeve further comprising an electrical connection to an electrode of a pacemaker external to the body;

a wire guide intended to be introduced into the tubular sheath of the introducer or the delivery catheter for the advancement of the implant, the wire guide comprising a metal part which also serves as a connection to the other electrode of the implant; external pacemaker.

According to an alternative embodiment, the electrode of the pacemaker connected to the electrically conductive sleeve fitted around the introducer sheath of the accessory catheter is the anode while that connected to the metal part of the wire guide introduced into the introducer or the delivery catheter is the cathode.

Advantageously, the electrically conductive sleeve consists of a one-piece piece of conductive material, such as carbon.

The sleeve may thus consist of a sheath comprising on its outer periphery an electrically conductive coating, such as a carbon coating. According to an advantageous embodiment, the sleeve is elastic so as to be able to slip on sheaths of peripheral arterial or venous catheters of different diameters, typically external diameters of between 0.2 and 2.2 mm.

According to a second alternative, the subject of the invention is an assembly for placing a cardiac, aortic or arterial implant, comprising:

an accessory catheter intended to be introduced into an artery or peripheral vein of the human body, the accessory catheter comprising at least one tubular introducer sheath and at least one electrically conductive element, a distal portion of which is visible on at least a portion the outer periphery of the sheath so as to be in contact with the subcutaneous tissue of the body or with the peripheral artery or vein and a proximal portion of which, accessible from outside the body, comprises an electrical connection so to serve as a connection to an electrode of a pacemaker external to the body;

a wire guide, intended to be introduced into the tubular sheath of the introducer or the delivery catheter for the advancement of the implant, the wire guide comprising a metal part serving also to connect to the other electrode external pacemaker.

It is specified here that an "accessory catheter" that can be designated by service catheter is a catheter introduced into a peripheral artery or vein also called indifferently accessory pathway, or secondary or servitude pathway.

According to one embodiment, the electrode of the pacemaker connected to the accessory catheter is the anode while that connected to the metal portion of the wire guide introduced into the introducer or the delivery catheter is the cathode.

Preferably, the electric conductive element of the accessory catheter is a wire or a metal strip housed at least in part in the thickness of the sheath, a distal portion of which is apparent at the outer periphery of the sheath.

The section of the wire or the metal strip may advantageously be between 0.25 and 5 mm ² . The assembly according to the invention may constitute a set of replacement of a cardiac valve percutaneously, the guidewire being adapted to perform the advancement of an artificial valve for replacing the heart valve.

It may also constitute a set of aortic stent or carotid stent, the wire guide being adapted to achieve the advancement of the stent or the stent or the wire guide being independent of that which brings the prosthesis or the balloon but which is coupled to another wire guide in contact with the patient's heart.

With the peripheral venous catheter according to the invention which incorporates an electrically conductive element at the periphery of its sheath, it is no longer necessary to plant a needle in the subcutaneous tissues or a cutaneous electrode to serve as a support for the electrode typically the anode of a pacemaker.

Nor is it necessary to use and set up an electro-systolic probe as according to the state of the art, commonly called temporary probe.

In addition, thanks to the invention, the stimulation intensity necessary for cardiac examination is lower than in the solutions according to the state of the art, because of a lower impedance of the vascular system with respect to the tissue. subcutaneous. Typically, the intensity of the current delivered, for a cardiac dump, can range from 1 to 20 mA and the voltage delivered from 0.5 to 15 volts.

The surgeon (s) in charge of the operation can thus connect the electrode, typically the anode of the pacemaker to the accessory catheter or the conductive sleeve fitted around the accessory catheter easily and then connect as usual the other electrode, typically the cathode to the wire guide of the valve-stent-balloon assembly or self-expanding valve-stent.

Thus, the step of preparing to stop the heart is simpler and faster to achieve.

In addition, the inventor believes that an accessory catheter according to the invention can reduce the risk of complications related to electro-systolic stimulation probes according to the state of the art that are placed in the right ventricle.

The introducer or delivery catheter may be introduced as usually transapically or transfemoral, which is preferred for its less invasive character for more fragile patients. The delivery introducer or catheter may incorporate a peripheral perfusion system, commonly referred to as "Flush", which may be in place to clean the interior of the introducer or catheter of any blood clot that may be present. .

The artificial valve can be introduced and positioned in the artery by means of a conventional valve catheter, itself introduced into the introducer. The artificial valve then occupies a folded position and does not impede the introduction and sliding of the valve catheter in the introducer then in the artery or in the delivery catheter and then in the artery.

Then, in the deployed position, the artificial valve bears against the outer wall of the native heart valve instead of the latter by crushing it.

A conventional valve catheter thus makes it possible to introduce and position the artificial valve in the appropriate place, by the same operation gesture as that for opening and crushing the native valve. After opening and crushing, the valve catheter is axially slid in the distal direction to bring the artificial valve to the proper level in the opening of the native valve.

The surgeon (s) involved in the patient apply) during the opening and crushing of the native valve and then after, cardiac stimulation by means of the external pacemaker, the electric current flowing between the cathode and the anode the pacemaker, the cathode being connected to the guide wire of the artificial valve and the anode being connected to the conductive element of the peripheral venous catheter according to the invention, in contact with the subcutaneous tissue of the patient or with the inner wall of a peripheral vein.

Simultaneously with ventricular pacing, the artificial valve is deployed. The valve catheter is then removed.

The same steps can be performed for all types of peripheral vascular interventions.

Thus, another object of the invention is a method for placing a cardiac, aortic or arterial implant comprising the following steps:

a / introduction of an introducer and / or delivery catheter percutaneously or into a peripheral artery of a human body;

b / introducing a wire guide into the tubular sheath of the introducer or delivery catheter for the advancement of a cardiac, aortic or arterial implant; c / introduction of an accessory catheter into an artery or peripheral vein of the human body; the accessory catheter comprising at least one tubular introducer sheath and at least one electrically conductive element whose distal portion is exposed on at least a portion of the outer periphery of the sheath, or the accessory catheter comprising a sleeve of conductive electrical material on at least part of its periphery;

d) connecting one of the two electrodes of an external pacemaker and the accessory catheter or the sleeve fitted with the accessory catheter and connecting the other of the two pacemaker electrodes and the wire guide;

e / implant placement;

g / before, simultaneously or after the stage, cardiac irradiation using the external pacemaker.

In general terms, the invention relates to the use of a cutaneous or subcutaneous or endovascular peripheral anode enabling via a metal guide positioned in the heart to propagate the electric current to the heart and thus to stimulate it at a frequency variable, typically between 40 and 220 beats per minute, to temporarily stabilize it by staggering it or to train it in case of bradycardia or other electrical conduction disorder stopping or slowing the heart rate during an infarction, an intervention coronary, valvular or peripheral arterial.

The endovascular anode may be anywhere on the arterial or venous circulatory system.

The voltage applied to obtain the cardiac output is preferably between 0.5 and 15 V. The current applied is advantageously between 1 and 20 mA.

The characteristic impedance is preferably between 300 and 700 ohms.

For an operation of placement of percutaneous valves or aortic stents (TEVAR) or balloon angioplasties of the aortic stenoses (coartations of the aorta), the frequency of the heart that one seeks to obtain by the cardiac uteration according to the invention is advantageously between 140 and 220 beats per minute.

For coronary application, in the case of using an angioplasty tool such as Rotablator® for example or in the management of infarction with conduction disorders or for the treatment of peripheral arteries such as Carotid arteries (vectors of cardiac slowdown by receptor stimulation around the carotid glomus), the frequency is advantageously between 50 and 100 beats per minute.

In summary, the advantages of an assembly according to the invention are those of an assembly according to the application WO2016 / 162315 A1 that can be enumerated as follows:

a simpler and faster setting up of an electrode, typically the ventricular pacing anode during the operation of replacing a deficient aortic valve or the operation of placing any aortic or arterial implant (aortic stent thoracic, stent);

removing the need to plant an additional subcutaneous needle as an electrode holder, typically a pacemaker anode;

less time and cost of replacing a defective heart valve or the operation of placing any aortic or arterial implant (thoracic aortic stent, stent);

an increased efficiency of the temporary stimulation to achieve the desired cardiac dune due to the lower impedance of the vascular system encountered by the stimulation electrical current since the sleeve around an accessory venous catheter is directly in contact with said system, at the contrary needles according to the state of the art that come into contact with the skin tissue of a patient who necessarily has a higher impedance;

increased efficiency of the temporary stimulation to achieve the desired cardiac output because of the stability of the rigid guide (diameter of the order of 1, 455 mm) in the left ventricle and the accessory catheter, instead of the instability of the electro-systolic probe according to the state of the art put in place in the right ventricle;

the possibility of performing temporary cardiac stimulation with a lower electric current due to the lower impedance of the vascular system encountered between the two electrodes of the external stimulator;

the elimination of the risk of complications associated with state-of-the-art temporary stimulation probes placed in the right ventricle;

the possible use of the delivery introducer or catheter for several different types of TAVI procedures, such as valve replacement aortic, pulmonary, tricuspid or mitral. In particular, for the replacement of a degenerate tricuspid valve, only the technique of introducing a stimulation probe into the right ventricle by means of the guide rail (diameter 0.89 mm) is possible because it is not conceivable to put both the rail guide and an electro-systolic probe since the expansion of the balloon or the prosthetic valve would compress the probe with the inherent risk of interrupting the stimulation or jamming the stimulation probe;

the possible use in the pediatric population during valvular or cardiac procedures on hearts more tachycardic, more mobile than in the adult population. In addition, it is a population in which the femoral venipuncture can be very difficult and the establishment of a right ventricular pacing probe. Finally, the infantile right ventricular walls are thin and fragile, thus increasing the risk of serious complications such as tamponade. This is also the population described in the publication [2];

the possible use for any type of peripheral vascular intervention. In addition, compared to an assembly according to the application WO2016 / 162315 A1, an assembly according to the invention has the following additional advantages:

no modification of the protocol, because the introduction of the accessory catheter (arterial or peripheral venous) according to the invention remains the same as for existing accessory catheters. This operation is very simple and easy to implement and can very well be done by an assistant or nurse, who does not need to have special skills for this task.

- increased interventional safety of a TAVI or any other type of cardiac intervention (mitral valve, triscupid valve) or any type of peripheral vascular intervention, since the peripheral catheter (accessory) is removed last when the procedure. With the accessory catheter and therefore the connection to the pacemaker installed until the last moment, one can restart cardiac stimulation even in emergency situation;

possibility of using any type of delivery catheter or introducer of TAVI or other type of heart valve or for those intended for existing peripheral vascular interventions, since the stimulation electrodes connected respectively to the wire guide and the arterial or venous catheter do not affect the choice of delivery catheter or introducer used in the TAVI.

The invention further relates to the use of the assembly with introducer or delivery catheter and with a peripheral venous catheter described above for the replacement of a aortic, pulmonary, tricuspid or mitral valve or the application of a thoracic aortic stent or a carotid stent.

detailed description

Other advantages and features of the invention will emerge more clearly from a reading of the detailed description of the invention, given by way of illustration and without limitation with reference to the following figures among which:

- Figure 1 is a perspective view of an introducer according to the state of the art, intended to be introduced into a femoral artery at the groin of a patient;

FIGS. 2A to 2C show, in partial longitudinal sectional view, different stages of sliding of a valve catheter in the introducer according to FIG. 1, in order to carry out the placement of an artificial valve in place of a valve. native aortic deficient;

FIG. 3 is a diagrammatic perspective view from the outside of a patient of both the step of placing a valve catheter and cardiac stimulation electrodes according to the state of the art;

FIG. 4 is a schematic perspective view of a delivery catheter according to the state of the art, intended to be introduced directly into the artery of a patient without the need for an introducer;

- Figure 5 schematically illustrates the use of an assembly according to the invention with a venous catheter according to the invention and with a delivery catheter of the prosthetic valve introduced directly into an artery of a patient.

In the following description and throughout the present application, the terms "distal" and "proximal" are used by reference with the body of a patient whose defective native aortic valve is replaced by an artificial aortic valve. . Thus, the distal end of an introducer is the innermost end of the patient during the replacement operation.

For the sake of simplification, the same elements in an assembly according to the invention and in that according to the state of the art are designated by the same references. It is specified that the different elements are not necessarily represented on the scale.

Figure 1 shows an introducer 1 for replacement of a cardiac valve transfemoral.

This introducer 1 of tubular general shape comprises between its proximal end 10 and its distal end 11, a tip 12 extended by at least one outer tubular sheath 13 formed of two tubular portions 14, 15 from the proximal side to the distal side, considered relative the introduction into a femoral artery of a patient to operate, that is to say from top to bottom in Figure 1.

The tip 12 generally incorporates a set of sealed valves to perform a hemostasis, that is to say, to ensure the maintenance of blood inside the blood vessels of the patient during the procedure.

The tubular sheath 13 may be extensible or not to be able to pass a surgical intervention device such as a valve catheter as explained below. The material constituting the sheath 13 is a biocompatible material, such as silicone. It can also be made of Teflon ^™ or polyurethane. The sheath may advantageously be covered on the outside with a hydrophilic layer and inside a layer with a low coefficient of friction material to facilitate the sliding of an intervention device.

The introducer 1 illustrated in FIG. 1 also comprises a rinsing device 16 with taps, commonly called "flush", integrated to rinse the inside of the introducer 1 by means of a suitable rinsing liquid.

All elements of the introducer 1 present in the proximal or external zone Z _E are intended to remain outside the body of the patient, the entire distal portion 15 of the sheath 13 defining the distal zone Zi is intended to be introduced into a femoral artery of a patient.

The introducer 1 illustrated is for example that marketed under the trade name "Edwards eSheath introducer sheath assembly" marketed by Edwards Lifesciences.

FIGS. 2A to 2C show the advancement of a valve catheter 2 consisting of a wire guide 20 and an assembly 21 consisting of an artificial valve attached to a radial expansion stent and a inflatable balloon to achieve this expansion, inside of the distal portion 14 of the tubular sheath of the introducer 1 already introduced into a femoral artery A.

The tip of the assembly 21 makes it easy to penetrate the deficient native aortic valve.

It can be seen in these figures that, as the valve catheter 2 slides, the portion 15 of the tubular sheath is temporarily deformed radially, forming a slight protrusion 150. When the tubular sheath is not extensible, it can not does not deform radially.

In FIG. 3, it can be seen that the hand M of a surgeon carries out the introduction of the valve catheter 2 into the introducer 1 already introduced into the femoral artery of a patient, the tip 12 projecting from the outside body C.

This introduction of the valve catheter 2 makes it possible to bring the assembly 21 to the deficient calcified aortic valve which must be replaced.

Usually, as also visible in this FIG. 3, a clamp 3 known as a crocodile clip is pinched onto the wire guide 20 of the valve catheter 2. This clamp 3 is connected to the cathode of a pacemaker not shown, located outside the body C.

A needle not shown is also planted in the subcutaneous tissues of the body C of the patient to be operated. On this needle is fixed a wire 4.

A crocodile-type clamp 5 is also fixed by clamping on the wire 4.

This clip 5 is connected to the anode of the pacemaker outside the body.

Thus, when the artificial valve is at the level of the native aortic valve to be replaced, the surgeon performs prior to the actual establishment of the artificial valve, that is to say the inflation of the balloon and therefore the expansion of the stent to which the valve is attached, rapid ventricular pacing of the left ventricle.

For this, an electrical signal is delivered between the cathode and the anode through the clamps 3, 5, the balloon acting as an electrical insulator between these two electrodes.

Figure 4 illustrates a delivery catheter 1 'which can be introduced directly into the artery of a patient without the need for an introducer. More specifically, the catheter 1 'comprises a tip 12 extended by an introducer sheath 13. The tip 12 comprises a connection 18 for inflating / deflating a balloon 7 at the distal end 11 which makes it possible to expand a not shown prosthetic valve.

Faced with numerous aortic valve replacement operations femoral as just described briefly, and in particular to the precise and delicate placement of the additional subcutaneous needle, and the establishment and maintaining the crocodile-type connection clamps on two remote supports, the inventor of the present invention has already thought of integrating the wire 4 directly into an introducer 1 or into a delivery catheter. This solution is described and claimed in the patent application WO2016 / 162315 A1.

While this solution brings many advantages over the technique according to the state of the art, it nevertheless has a significant disadvantage that is to require the realization of specific introducers or delivery catheters.

Also, the inventor first thought to integrate the function of the wire not in an introducer or in a specific delivery catheter but to integrate it into an existing peripheral venous catheter 1 ".

Such a venous catheter 1 '' which may be of small diameter, typically 2mm or less, and of short length. It meets the standards for intravascular peripheral catheters. It is recalled here that the primary function of a peripheral venous catheter is to bring a patient's rehydration fluid, a drug treatment or a transfusion.

More particularly, in the context of a TAVI, the arterial catheter 1 "makes it possible to perform a control angiogram, firstly to control the positioning of the aortic valve prosthesis and secondly, to verify the no complications, especially vascular or even manage them. (The primary function of a peripheral venous catheter is to bring a patient's rehydration fluid, drug therapy or transfusion.)

According to the invention, the introducer sheath of a peripheral arterial catheter 1 "integrates peripherally an electrically conductive wire or band, of very small thickness, typically of the order of a millimeter or less, which only adds a small extra thickness to a conventional venous catheter sheath and therefore does not interfere with the progression thereof when introduced into a peripheral artery or vein Y. In practice, a surgeon or interventionist doctor wishing to perform a cardiac pacemaker replacement operation with concomitant cardiac stimulation to the placement of the prosthetic valve, begins by placing the peripheral arterial or venous catheter 1 "so that the conductive element of its sheath comes to touch either a subcutaneous area of the patient or the wall of the artery or peripheral vein of the patient.

Once this implementation has been performed, the introduction of the introducer 1 or the delivery catheter 1 'can be made as usual by the surgeon.

Once the positioning of the introducer 1 or the catheter 1 'in the femoral artery A has been completed, the electrical connection 6 can be connected directly to the anode of an external pacemaker 9 by means of a connection wire. 90.

Usually, a clamp, such as the crocodile clip 3 shown in FIG. 3, may in turn be pinched to the wire guide 20 of an introducer 1 or a valve catheter 1 '. This clamp is connected to the cathode of the external pacemaker by means of a connecting wire 91.

Thus, temporary cardiac stimulation to achieve the desired heart rate may occur between the cathode electrically connected to the wire guide 20 and the anode electrically connected to the electrical conductive member of the peripheral venous catheter 1 ".

FIG. 5 schematizes all the elements involved, namely the use of a delivery catheter assembly 1 'for the delivery of a prosthetic valve 10 through the aortic arch of a patient and with a venous catheter 1 "device according to the invention.

As can be seen in this Figure 5, the catheter 1 'is introduced from the femoral artery and a wire guide 20 is introduced directly into the delivery catheter 1'. The distal end 21 of the wire guide 20 wraps around itself coming into contact with the left ventricular endothelium of the patient. This distal end 21 of the wire guide 20 always ensures the electrical contact and therefore the passage of the current from the cathode of the external pacemaker 9 via the electrical connecting wire 91.

The current flow to the anode of the pacemaker 9 is in turn provided by the conductive sheath of the peripheral venous catheter 1 "and therefore in contact with the subcutaneous tissue of the patient or the peripheral vein and further connected to the electrical connection wire 90.

The invention is not limited to the examples which have just been described; it is possible in particular to combine with one another characteristics of the illustrated examples within non-illustrated variants.

Other variants and improvements may be provided without departing from the scope of the invention.

References cited

[1]: "Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients", Gilard et al; the New England Journal of Medicine: pp 1705-1715

[2]: "Left Ventricular Guidewire Pacing to Simplify Aortic Balloon Valvuloplasty," Susanne Navarini et al; Catheterization and Cardiovascular Interventions 73: pp 426-427 (2009)

[3]: "A Novel Approach for Transcoronary Pacing a Porcine Model", Roland Prodzinsky et al; Journal of Invasive Cardiology 24 (9): pp 451-455 (2012)

[4]: "Optimizing of Transcoronary Pacing in a Porcine Model," Konstantin M. Heinroth, et al, Journal of Invasive Cardiology 21, pp. 634-638 (2009)

Claims

1. Set of implantation of a cardiac, aortic or arterial implant, comprising

a device forming an introducer (1) or a valve delivery catheter (G) comprising at least one tubular introducer sheath (13) intended to be introduced into an artery of a human body (C) and the case appropriate to pass a surgical intervention device,

an accessory catheter (1 ") intended to be introduced into an artery or a peripheral vein of the human body;

- A sleeve (6) adapted to be fitted around the accessory catheter, the sleeve being made of electrically conductive material on at least a part of its outer periphery so that when the accessory catheter is introduced into the artery or into the peripheral vein of the human body, the conductive periphery of the sleeve is in contact with the subcutaneous tissue of the body or with the wall of the artery or vein, the sleeve further comprising an electrical connection (7, 8) to an electrode of a pacemaker external to the body;

a wire guide (20) intended to be introduced into the tubular sheath (13) of the delivery introducer or delivery catheter for the advancement of the implant, the wire guide (20) comprising a metal part serving for off connection to the other electrode of the external pacemaker.

2. The assembly of claim 1, the electrode of the pacemaker connected to the electrically conductive sleeve (6) fitted around the introducer sheath (14 ") of the accessory catheter being the anode while that connected to the metal part of the wire guide (20) introduced into the introducer (1) or delivery catheter is the cathode.

3. An assembly according to one of claims 1 or 2, wherein the electrically conductive sleeve is constituted by a one-piece piece of conductive material, such as carbon.

4. The assembly of claim 3, the sleeve being constituted by a sheath comprising on its outer periphery an electrically conductive coating (4), such as a carbon coating.

5. The assembly of claim 3 or 4, the sleeve being elastic so as to be able to slip on cladding arterial or peripheral venous catheters of different diameters, typically external diameters of between 0.2 and 2.2 mm.

6. Set of implanting a cardiac, aortic or arterial implant, comprising:

a device forming an introducer (1) or a valve delivery catheter (1 ') comprising at least one tubular introducer sheath (13) intended to be introduced into an artery of a human body (C) and the if necessary to let a surgical intervention device pass,

an accessory catheter (1 ") intended to be introduced into an artery or a peripheral vein of the human body, the accessory catheter comprising at least one tubular introducer sheath (13) and at least one electrically conductive element including a distal portion is apparent on at least a portion of the outer periphery of the sheath so as to be in contact with the subcutaneous tissue of the body or with the peripheral artery or vein and a proximal portion thereof accessible from outside the body (C), comprises an electrical connection so as to serve as a connection to an electrode of a pacemaker external to the body;

7. The assembly of claim 6, the electrode of the pacemaker connected to the accessory catheter being the anode while that connected to the metal portion of the wire guide (20) introduced into the introducer (1) or delivery catheter. is the cathode.

8. Assembly according to one of claims 6 or 7, wherein the electrical conductive element of the accessory catheter is a wire or a metal strip (4) housed (e) at least partly in the thickness of the sheath a distal portion is apparent at the outer periphery of the sheath.

9. The assembly of claim 8, the section of the wire or the metal strip being between 0.25 and 5 mm ² .

10. Assembly according to one of the preceding claims, constituting a replacement assembly of a cardiac valve percutaneously, the guidewire being adapted to perform the advancement of an artificial valve for replacing the heart valve.

11. An assembly according to one of the preceding claims, constituting an assembly for placing a stent or a carotid stent, the wire guide being adapted to perform the advancement of the stent or the stent or the wire guide. being independent of the one bringing the prosthesis or the balloon but which is coupled to another wire guide in contact with the patient's heart.