Assemblies for replacing heart valves or for coronary angioplasty

Abstract

The invention relates to a combination for replacing a heart valve or for coronary angioplasty, with an insertion sheath (13) of an introducer (1) or a delivery catheter (1') which is smaller in size than the introducer, for insertion in an artery of the body. The invention consists essentially in that either a metal support for an electrode of a heart pacemaker is integrated in the member assembled around the insertion sheath, which is inserted in an artery of the patient or in a guide wire which becomes a bipolar support for the electrode; or a cathode of an external heart pacemaker is connected to a guide wire of an artificial valve and an anode of the heart pacemaker is connected to a transcutaneous electrode which is in contact with the skin of the patient.

Description

[0001] The present application is a divisional application of the invention patent application entitled “ASSEMBLY FOR REPLACEMENT OF A HEART VALVE OR ASSEMBLY FOR CORONARY ANGIOPLASTY”, with an international application date of October 5, 2017, an international application number of PCT / EP2017 / 075362, and a national application number of 201780070585.6. Technical Field

[0002] The present invention relates to an assembly for percutaneous replacement of a heart valve or for coronary angioplasty, comprising a delivery catheter for the valve and, if necessary, an insertion device, generally called an "introducer".

[0003] In particular, the present invention relates to improving the assistance of replacement due to heart failure by means of a cardiac pacemaker.

[0004] Although described with reference to aortic valve replacement, the assembly of the present invention may be used as an assembly for coronary angioplasty procedures with or without placement of a prosthesis commonly known as a "stent", particularly in emergency situations or during complex procedures.

[0005] Likewise, although described with reference to aortic valve replacement, it will be apparent that the device of the present invention may also be used to replace other heart valves, such as the tricuspid or mitral valves.

[0006] Generally speaking, the introducer and / or delivery catheter of the device of the present invention can be inserted into the patient's body percutaneously, more specifically, transfemorally, transaortally, transcarotidally, or subclavianally. Background Art

[0007] Well-known heart diseases are closely related to calcified constriction of the tricuspid valve or the aortic valve of the heart, which is the valve that separates the left ventricle of the heart, the aorta, and can be in an open position to allow blood to flow from the heart to other body tissues.

[0008] Tightness or extra tightness prevents the aortic valve from opening properly, thus becoming diseased, also known as calcific aortic stenosis.

[0009] Treatment for this condition involves replacing the defective aortic valve in the heart.

[0010] The most common method for replacing a defective aortic valve is to open the chest, place the patient on extracorporeal circulation, temporarily stop the heart, open the heart, perform a resection, and replace the original valve with an artificial valve or prosthesis.

[0011] The major drawbacks of these sequential procedures mean longer hospital stays, more complex surgeries, higher costs, and are limited to a select group of patients because, in many cases, the physician and / or surgeon deems it unfeasible to perform "open-heart" surgery, which is too dangerous given the patient's combined condition, particularly the required cardiac arrest and extracorporeal circulation.

[0012] To address this shortcoming, some have proposed non-invasive heart valve replacements, but these are always performed under extracorporeal circulation. Examples include International Patent Applications WO 93 / 01768 and WO 97 / 28807, and U.S. Patents US 5814097, US 5370685, and US 5545214, which describe known non-invasive techniques and devices employing these techniques.

[0013] However, existing technologies are considered to be not entirely satisfactory and need to be improved.

[0014] In particular, these techniques have the following major drawbacks:

[0015] - In any case, the patient is prescribed extracorporeal circulation; it is difficult to perform;

[0016] - The diameter of the original valve resection cannot be precisely controlled, making it difficult to subsequently machine the prosthetic valve to the exact size;

[0017] - Risk of dissemination of fragments of the often calcified native valve in the body tissue, which could lead to embolism;

[0018] - Risk of perforation of the aortic wall or heart wall;

[0019] - There is a risk of rapid backflow of blood during native valve resection.

[0020] To address the shortcomings of these technologies, one approach is to implant a percutaneous artificial aortic valve, which uses intravascular processing technology to insert a catheter into a blood vessel such as the aorta.

[0021] Thus, the native aortic valve, which has become functionally impaired due to calcification, is replaced by an artificial valve, avoiding the aforementioned usual arduous cardiac surgery.

[0022] Currently, artificial valves can be implanted percutaneously in different ways: transfemoral, which is done from the femoral artery to the heart, or transapical, transaortic, transcarotid, or subclavian, which means that the heart does not need to be opened in the chest or undergo extracorporeal circulation.

[0023] The operation itself consists in placing an artificial valve (prosthesis) that reproduces the overall shape of a normal native aortic valve in the place of the calcified (diseased) native aortic valve that the prosthesis implant replaces.

[0024] To this end, the artificial valve is made of the pericardium, a thin membrane surrounding the heart of a pig or cow, and is pre-fixed in a radially expandable tubular metal stent. For coronary artery stents, the metal stent is assembled from wires of shape memory materials such as nickel-titanium alloy, cobalt-chromium, and stainless steel 316L.

[0025] The valve-stent assembly is then compressed onto the end of a tubular sheath, called a delivery catheter, which can be inserted either directly into the artery or into an introducer that allows access to the artery while maintaining hemostasis.

[0026] Therefore, the surgeon slides the valve-stent assembly in an introducer or directly in a delivery catheter until the device reaches the diseased aortic valve. The valve-stent assembly is then placed at the diseased valve by inflating a balloon before implantation.

[0027] There are also valve delivery catheters that have a balloonless valve-stent combination in which the valve automatically expands and contracts, and radially expandable valves can be placed by simple retraction of a surrounding sheath, thus eliminating the need to pre-inflate a balloon.

[0028] For details, see U.S. Patents US 7018406, US 7892281, US 8652202 and US 8747459.

[0029] When placing the valve in the strict sense, it is necessary to temporarily stop the heart for a short time by rapid ventricular stimulation to minimize the blood flow between the valves and avoid or at least reduce the potential for embolism.

[0030] Thus, this temporary cardiac arrest, also often called "heart failure", consists in causing the heart to beat 150 to 200 times per minute, so that it can no longer contract effectively, which reduces blood pressure, simulates tachycardia or ventricular fibrillation, and thus stabilizes the heart.

[0031] This stabilization of the heart stabilizes the balloon, increasing the precision with which the prosthetic valve can be implanted in seconds.

[0032] There are bipolar stimulation catheters with two electrodes, called drive probes or electrosystolic stimulation probes, for temporary intracardiac stimulation of the right ventricle.

[0033] These electroconstriction stimulation probes have several drawbacks, as detailed below.

[0034] First, this probe constitutes a central venous access, which carries an additional risk of vascular complications in a frail, follow-up patient population. The French registry designated "France 2", which covers aortic valve replacement surgery, commonly known as TAVI, or "Transcatheter Aortic Valve Implantation", shows a risk factor of 4.7% for major vascular complications. This result is published on page 1709 of the publication [1].

[0035] Secondly, the probe is relatively rigid and therefore, its implantation in the fragile right ventricle, whose walls are thinner than those of the left ventricle, creates a serious risk of a phenomenon known to surgeons as "cardiac tamponade", which indicates severe circulatory insufficiency and may lead to the death of the patient.

[0036] Furthermore, it should be noted that this risk exists not only during the operation, when the electrosystolic probe is placed, but also after the operation, when the bedridden patient moves, thereby moving the existing probe and possibly puncturing the wall of the right ventricle.

[0037] Furthermore, there is a risk of the electrosystolic stimulation probe moving during the critical moment of valve implantation. In fact, the stimulation probe is not fixed to the heart wall and can therefore move, resulting in a loss of capture of the electrical stimulation signal.

[0038] As a result, the heart is no longer stimulated and therefore beats too fast, interfering with the positioning of the valve or balloon.

[0039] Another risk of using this probe is the risk of infection at the puncture site. The risk factor for the registered France 2 is less than 1%: see publication [1].

[0040] Finally, the surgeon cannot ignore the additional operative time of placing a temporary stimulating probe, which is never a simple procedure to perform.

[0041] The publication [2] suggests the advantages of ventricular stimulation of the left ventricle rather than the right ventricle, without the use of a dedicated transvenous stimulation catheter, but rather using an external pacemaker with a guidewire.

[0042] Thus, the embodiment proposed in this publication [2] consists in using a guide wire of an inflatable balloon supporting a stent as a portion connected to the cathode of a cardiac pacemaker and a skin electrode or a needle inserted in the subcutaneous tissue as a support for the anode of the cardiac pacemaker.

[0043] Publications [3] and [4] have demonstrated the effectiveness of using a guidewire with an inflatable balloon supporting a stent as a cathode connection to a pacemaker and a skin electrode or a needle inserted in the subcutaneous tissue as a support for the anode of the pacemaker for temporary cardiac stimulation at a lower stimulation voltage during coronary angioplasty in pigs.

[0044] Therefore, the advantages of the proposed embodiment are that it avoids the need to insert a dedicated additional catheter, avoids an entrance to the heart, shortens the operation time, reduces the cost of the operation, and also reduces the risk of complications related to the insertion of a dedicated catheter, while allowing for stimulation that is as effective as transvenous stimulation.

[0045] Furthermore, in contrast to the previously mentioned right ventricular electrical contraction stimulation probes that can pose a risk of cardiac tamponade, the guidewire used in this technique is very stable, permanently bearing against the thicker left ventricular wall until it serves as a guide to advance the stent-balloon-valve device through the valve.

[0046] However, this technique also requires the implantation of an electrode or an additional hypodermic needle which must be precisely positioned and maintained with an alligator clip-type connection clamp on two separate supports.

[0047] Patent application PCT / EP2016 / 057385 by the inventors of the present invention proposes installing a pacemaker electrode directly in an insertion sheath (introducer or delivery catheter) inserted into a patient's artery. This invention allows surgeons to more easily and quickly manipulate and implant a pacemaker electrode.

[0048] A drawback of this patent application is that it requires an introducer or a specific delivery catheter.

[0049] Advantageously, however, it may be possible to have one or more solutions that can be adapted to existing introducers or catheters, ie which do not have electrodes mounted therein.

[0050] The present invention is intended to at least partially address this need. Summary of the Invention

[0051] To this end, the present invention relates, according to a first embodiment, to an assembly for percutaneous replacement of a heart valve, comprising:

[0052] - a device forming an introducer having at least one tubular insertion sheath for insertion into an artery of the body and for passing a surgical device, such as a delivery catheter;

[0053] a sleeve adapted to fit around the insertion sheath, the sleeve being made of a conductive material on at least a portion of its outer periphery so that when the insertion sheath, with the sleeve fitted around it, is inserted into an artery in the body, the conductive periphery of the sleeve contacts subcutaneous tissue of the body or the artery, the sleeve further comprising an electrical connector connected to an electrode of a cardiac pacemaker located outside the body;

[0054] - At least one guide wire for insertion into the tubular insertion sheath of the introducer for advancing an artificial valve for replacing a heart valve, the guide wire having a metal portion which also serves as a connection to another electrode of an external cardiac pacemaker.

[0055] According to a second embodiment, the present invention relates to an assembly for percutaneous replacement of a heart valve having:

[0056] - a device forming a delivery catheter for delivering a valve, the delivery catheter having at least one tubular insertion sheath for insertion into an artery of the body;

[0057] a sleeve adapted to fit around the insertion sheath, the sleeve being made of a conductive material on at least a portion of its outer periphery so that when the insertion sheath with the sleeve fitted around it is inserted into an artery in the body, the conductive periphery of the sleeve contacts subcutaneous tissue of the body or the artery, the sleeve further comprising an electrical connector connected to an electrode of a cardiac pacemaker outside the body;

[0058] - At least one guide wire for insertion into the tubular insertion sheath of the delivery catheter for advancing an artificial valve for replacing a heart valve, the guide wire having at least one metal portion which also serves as a connection to another electrode of an external cardiac pacemaker.

[0059] According to one embodiment, the electrode of the pacemaker connected to the conductive sleeve fitted around the introducer or delivery catheter is the anode, while the electrode connected to the metal portion of the guidewire is the cathode.

[0060] The present invention also relates to an electrically conductive sleeve for use in the aforementioned device.

[0061] The sleeve may be constructed from a unitary member of a conductive material such as carbon.

[0062] It can also consist of a sheath which has a conductive coating, for example a carbon coating, on its outer periphery.

[0063] According to an advantageous embodiment, the sleeve can be flexible so as to fit over insertion sheaths of different diameters of an introducer or delivery catheter, typically having an outer diameter between 1.67 and 8 mm (5 and 24 French). Typically, for sheaths used in assemblies for replacing heart valves, the outer diameter can be 4 mm, 4.67 mm, 5.33 mm, or 6 mm.

[0064] According to a third embodiment, the present invention relates to an assembly for percutaneous replacement of a heart valve having:

[0065] - a device forming an introducer having at least one tubular insertion sheath for insertion into an artery of the body and for passing a surgical device, such as a delivery catheter;

[0066] a transcutaneous electrode having an adhesive portion and a conductive portion made of a conductive material, the adhesive portion being adapted to adhere to the skin of the body into which the insertion sheath is inserted, so that when the adhesive portion adheres to the skin of the body, the conductive portion is capable of transmitting an electric current through the skin, the conductive portion further having an electrical connector connected to an electrode of a cardiac pacemaker outside the body;

[0067] - At least one guide wire for insertion into the tubular insertion sheath of the introducer for advancing an artificial valve for replacing a heart valve, the guide wire having a metal portion which also serves as a connection to another electrode of an external cardiac pacemaker.

[0068] According to a fourth embodiment, the present invention relates to an assembly for percutaneous replacement of a heart valve, comprising:

[0069] - a device forming a delivery catheter for delivering a valve, the delivery catheter having at least one tubular insertion sheath for insertion into an artery of the body;

[0070] a transcutaneous electrode having an adhesive portion and a conductive portion made of a conductive material, the adhesive portion being adapted to adhere to the skin of the body into which the insertion sheath is inserted, so that when the adhesive portion adheres to the skin, the conductive portion is capable of transmitting an electric current through the skin, the conductive portion further having an electrical connector connected to an electrode of a cardiac pacemaker outside the body;

[0071] - At least one guide wire for insertion into the tubular insertion sheath of the delivery catheter for advancing an artificial valve for replacing a heart valve, the guide wire having at least one metal portion which also serves as a connection to another electrode of an external cardiac pacemaker.

[0072] According to one embodiment, the electrode of the pacemaker connected to the percutaneous electrode is the anode, and the electrode connected to the metal portion of the guide wire is the cathode.

[0073] The present invention also relates to a transcutaneous electrode for use in the aforementioned assembly.

[0074] According to a fifth embodiment, the present invention also relates to an assembly for percutaneous replacement of a heart valve, comprising:

[0075] - a device forming an introducer having at least one tubular insertion sheath for insertion into an artery of the body and for passing a surgical device, such as a delivery catheter;

[0076] -At least one guide wire, called a bipolar guide wire, for insertion into a tubular insertion sheath of an introducer for advancing an artificial valve for replacing a heart valve, the guide wire having a metal core, which is covered with an electrically insulating sheath in a central portion between a proximal end and a distal end of the guide wire, the metal core being non-electrically insulated over the rest of the guide wire's length, the electrically insulating sheath housing a conductive member, the distal portion of the conductive member being exposed over at least a portion of the outer periphery of the electrically insulating sheath so as to be in contact with subcutaneous tissue of the body or with an artery, while the proximal portion of the conductive member being exposed over at least a portion of the outer periphery of the electrically insulating sheath so as to be accessible from outside the body when the guide wire is inserted into the insertion sheath, the proximal portion being used as a connection to one electrode of a cardiac pacemaker outside the body, and the metal core of the bipolar guide wire being used as a connection to another electrode of the external cardiac pacemaker.

[0077] According to a sixth embodiment, the present invention relates to an assembly for percutaneous replacement of a heart valve, comprising:

[0078] - a device forming a delivery catheter for delivering a valve, the delivery catheter having at least one tubular insertion sheath for insertion into an artery of the body;

[0079] - At least one guide wire, referred to as a bipolar guide wire, is intended to be inserted into a tubular insertion sheath for delivering an artificial valve for replacing a heart valve, the guide wire having a metal core covered with an electrically insulating sheath in a central portion between a proximal end and a distal end of the guide wire, the metal core being electrically non-insulated over the remaining length of the guide wire, the electrically insulating sheath being provided with a conductive member, the distal portion of the conductive member being exposed over at least a portion of an outer periphery of the electrically insulating sheath so as to be in contact with subcutaneous tissue of the body or with an artery, the proximal portion of the conductive member being exposed over at least a portion of an outer periphery of the electrically insulating sheath so as to be accessible from outside the body when the guide wire is inserted into the insertion sheath, the proximal portion being used as a connection to one electrode of a cardiac pacemaker outside the body, and the metal core of the bipolar guide wire being used as a connection to another electrode of the external cardiac pacemaker.

[0080] According to one embodiment, the electrode of the cardiac pacemaker connected to the conductive member housed in the electrically insulating sheath of the guide wire is the anode, and the electrode connected to the metal core of the guide wire is the cathode.

[0081] According to an advantageous embodiment of the invention, the metallic conductive member is a metal layer embedded in the insulating sheath, except for the exposed parts of the conductive member, ie the distal part and the proximal part.

[0082] According to one embodiment, the non-electrically insulated distal end of the metal core of the guidewire, which is intended to contact the wall of the left ventricle of the patient's heart, is a more flexible portion than the rest of the guidewire. Preferably, the more flexible portion is adapted to coil upon contact with the wall of the left ventricle of the patient's heart.

[0083] The distal portion of the conductive member is connected to an electrical connector, which is itself used to connect to an electrode of a pacemaker outside the body.

[0084] The present invention also relates to a bipolar guidewire for use with the aforementioned assembly. The bipolar guidewire comprises a metal core covered by an electrically insulating sheath in a central portion between the proximal and distal ends of the guidewire. The metal core is electrically non-insulated along the remainder of the guidewire length. The electrically insulating sheath houses a conductive member, with a distal portion of the conductive member exposed over at least a portion of the outer periphery of the electrically insulating sheath, and a proximal portion of the conductive member also exposed over at least a portion of the outer periphery of the electrically insulating sheath.

[0085] While studying options for the solution proposed in the aforementioned patent application PCT / EP2016 / 057385, the inventors conducted a study among existing solutions for cardiac stimulation.

[0086] Therefore, known stimulation electrodes have been tested specifically for transient percutaneous cardiac stimulation. This technique is recommended for emergency bradycardia treatment or for preventing cardiac arrhythmias accompanied by tachycardia.

[0087] However, this electrode has not yet been considered for testing in heart failure.

[0088] Surprisingly, the inventors achieved effective heart failure with the cathode of the external pacemaker connected to the guidewire of the prosthetic valve and the anode connected to a percutaneous electrode in contact with the patient's skin.

[0089] The inventor also considers that the metal support of an electrode of the cardiac pacemaker is installed in a member that is assembled around an insertion sheath inserted in the patient's artery. Therefore, the sleeve of the present invention directly contacts the patient's artery.

[0090] Finally, the inventors considered mounting the metal support of one electrode of a cardiac pacemaker not directly in a sheath inserted into the patient's artery as in the aforementioned patent application, but in a guide wire.

[0091] The bipolar guidewire of the present invention serves solely as a support for two electrical connectors connected to the anode and cathode of an external cardiac pacemaker. Thus, the metal core serves as a support for one of the electrical connectors, while the insulated proximal portion of the conductive member of the metal core serves as a support for the other of the electrical connectors.

[0092] Therefore, heart failure can be treated with bipolar electrical stimulation, which has the advantage of requiring a very low electrical stimulation threshold.

[0093] The insertion sheath can be an introducer, or directly a delivery catheter that is smaller than the introducer in size. In fact, the delivery catheter of the valve does not need an introducer because it can be directly inserted in the patient's artery.

[0094] With the aid of various embodiments of the present invention, it is no longer necessary to implant a needle or a skin electrode in the subcutaneous tissue to serve as a support for the electrode, typically the anode of a cardiac pacemaker.

[0095] There is no longer a need to use and implant a prior art electroconstriction probe, which is often referred to as a temporary probe.

[0096] Furthermore, with the present invention, the required stimulation intensity for heart failure is lower than with prior art solutions because the impedance of the vascular system is lower relative to the subcutaneous tissue. Typically, for heart failure, the delivered current intensity can be 10 to 20 milliamperes and the delivered voltage can be 0.5 to 10 volts.

[0097] Thus, the operating surgeon readily connects one electrode, typically the anode of the pacemaker, to a conductive sleeve mounted around an introducer or delivery catheter, or a percutaneous electrode, or a bipolar guidewire, and then connects another electrode, typically the cathode, to the guidewire of the valve-stent-balloon assembly or the self-expanding valve-stent assembly.

[0098] Therefore, the preparation phase for cardiac arrest is simpler and faster to implement.

[0099] Additionally, the inventors believe that the sleeve or percutaneous electrode or bipolar guidewire of the present invention may reduce the risk of complications associated with prior art electrosystolic stimulation probes placed in the right ventricle.

[0100] The introducer or delivery catheter can usually be inserted transapically or transfemorally, making it particularly noninvasive in frail patients.

[0101] The introducer or delivery catheter may be fitted with a peripheral irrigation system, often referred to as a "flush system", arranged to flush any blood clots that may be present from within the introducer or catheter.

[0102] Thus, advantageously, for a replacement heart aortic valve assembly, the introducer may be a known introducer, such as that commercially produced by Edwards Lifesciences under the trade name "Edwards eSheath Insertion Sheath Assembly."

[0103] The artificial valve can be inserted and positioned in the artery using a conventional valve catheter that is inserted into the introducer. Thus, the artificial valve is in a collapsed position that does not hinder the insertion and sliding of the valve catheter into the introducer and then into the artery, or into the delivery catheter of the present invention and then into the artery.

[0104] Then, in the deployed position, the artificial valve rests on the outer wall of the native heart valve, replacing it in its place.

[0105] Therefore, a conventional valve catheter can be used to insert and position the artificial valve in the appropriate position by the same action as cutting and compressing the original valve. After the original valve is cut and compressed, the valve catheter slides axially in the distal direction to position the artificial valve in the opening of the original valve.

[0106] The surgeon operating on the patient applies cardiac stimulation using an external pacemaker during the incision and compression of the native valve, and then thereafter, with current flowing between the cathode and anode of the stimulator, the cathode being connected to the guide wire of the artificial valve, and the anode being connected to the conductive sleeve of the present invention, which is installed around the outer tubular sheath of the introducer or delivery catheter and is in contact with the patient's subcutaneous tissue, or in contact with the inner wall of the artery.

[0107] Simultaneously with ventricular stimulation, the prosthetic valve deploys, and the valve catheter is then withdrawn.

[0108] In summary, the advantages of the assembly of the present invention are the same as those of the assembly of patent application PCT / EP2016 / 057385, which are listed as follows:

[0109] - Simpler and faster implantation of a single electrode, typically a ventricular stimulation anode, during aortic valve replacement surgery for a hypofunctioning aortic valve;

[0110] - No need to implant an additional hypodermic needle as a support for the electrode, which is usually the anode of the pacemaker;

[0111] - Replacement of dysfunctional heart valves is quick and inexpensive.

[0112] - high efficiency of temporary stimulation in the desired heart failure due to the low impedance of the vascular system encountered by the stimulation current, since the sleeve surrounding an introducer or a delivery catheter is in direct contact with the system, as opposed to the needles of the prior art, which are in contact with the patient's skin tissue, which necessarily has a higher impedance;

[0113] - High efficiency of temporary stimulation during desired heart failure due to the stability of the rigid guide (approximately 1.455 mm in diameter) in the left ventricle, rather than the instability of the prior art electrosystolic probe placed in the right ventricle;

[0114] - Temporary stimulation can be performed with less high currents because the impedance of the vascular system encountered between the two electrodes of the external stimulator is low;

[0115] - No risk of complications associated with prior art temporary stimulation probes placed in the right ventricle;

[0116] - The introducer or delivery catheter can be used for a variety of transcatheter aortic implantation procedures, such as aortic, pulmonary, tricuspid, or mitral valve replacement. In particular, for the replacement of a variant tricuspid valve, a technique using only one stimulation probe inserted into the right ventricle using a guide-rail (0.89 mm diameter) can be considered, as the simultaneous use of the guide-rail and an electroconstriction probe is not conceivable, as the inflation of the balloon or prosthetic valve would compress the probe, with the inherent risk of interruption of stimulation or entrapment of the stimulation probe;

[0117] - can be used in the pediatric population, who are undergoing valve or cardiac surgery, as their heart is more tachycardic and more variable than in the adult population. Furthermore, it concerns populations where femoral artery venous puncture is difficult and a right ventricular stimulation probe is to be implanted. Finally, the right ventricle of young children has a thin and fragile wall, thus increasing the risk of serious complications such as cardiac tamponade. It also concerns populations described in publication [2];

[0118] - It can be used in the field of coronary angioplasty for emergency and complex procedures, in which temporary cardiac stimulation must be performed effectively and very quickly. For this purpose, an introducer or delivery catheter with a sleeve of the present invention avoids the time required in the prior art to implant an electrode or an additional hypodermic needle, which can be determined during these procedures.

[0119] The only relative limitation of the sleeve, percutaneous electrode or bipolar guidewire of the present invention is the installation of the sleeve around the insertion sheath at the beginning of the procedure, during preparation. However, this operation is very simple and easy to perform, and can be performed by an assistant or nurse without requiring specialized skills.

[0120] The present invention also relates to an assembly with an introducer or delivery catheter having a sleeve as described above for use in aortic valve, pulmonary valve, tricuspid valve or mitral valve replacement surgery.

[0121] Finally, the present invention relates to an assembly with an introducer or delivery catheter having a hub as described above for use in coronary angioplasty procedures, in particular in emergency situations.

[0122] This use is particularly advantageous in three surgical situations that may be encountered during coronary angioplasty.

[0123] The first case is the treatment of acute infarction, which causes conduction disturbances such as extreme bradycardia or high-degree atrioventricular block. Using an introducer with the sleeve of the present invention, it is possible to avoid the use of prior art electroconstriction probes, which are not non-invasive and require a non-negligible additional implantation time.

[0124] The second case is usually a product called The known milling device is used to mill the calcified coronary artery lesions in the coronary artery. Therefore, the use of the catheter introducer with a sleeve of the present invention can also make up for the defects of the electrosystolic cardiac stimulation probe of the prior art.

[0125] The third situation is to place a stent in some parts of the coronary artery near its origin (ostium). These areas are very mobile relative to the surgical catheter, and these tissue structures require great precision in stent implantation. Using the introducer with a sleeve of the present invention, the stent can be kept stable before and during its placement. BRIEF DESCRIPTION OF THE DRAWINGS

[0126] Other advantages and features of the present invention will be better understood from the detailed description given by way of illustration and non-limiting example with reference to the accompanying drawings, which are as follows:

[0127] - FIG. 1 is a perspective view of a prior art introducer for insertion into the femoral artery at the groin of a patient;

[0128] - Figures 2A to 2C show in partial longitudinal section the different sliding steps of a valve catheter in the introducer shown in Figure 1 in order to replace an artificial valve at the site of a non-functional native aortic valve;

[0129] FIG3 is a schematic perspective view showing the steps for simultaneously placing a valve catheter and a pacemaker electrode from outside the patient's body according to the prior art;

[0130] FIG4 is a perspective view of a delivery catheter according to the prior art, the delivery catheter being intended to be inserted directly into a patient's artery without the need for an introducer;

[0131] - Figure 5 is a perspective view of a conductive sleeve according to the present invention, the sleeve being adapted to fit around a device forming an introducer of the prior art as shown in FIG. 1 , or a delivery catheter of the prior art as shown in FIG. 4 ;

[0132] - Figure 6 It is a partial longitudinal sectional view showing Figure 5 The sleeve shown is fitted around the prior art introducer shown in FIG1 ;

[0133] - Figure 7 is a perspective view of a percutaneous electrode used in an assembly for percutaneous replacement of a heart valve for heart failure;

[0134] - Figure 8 The steps of simultaneously placing a valve catheter and a pacemaker electrode from outside the patient's body according to the present invention are shown in a perspective schematic diagram;

[0135] - Figure 9 is a perspective view of a bipolar guidewire of the present invention for use in an assembly for percutaneous replacement of a heart valve to obtain cardiac tremor

[0136] - Figure 9A and 9B is buried in Figure 9 A cross-sectional view of the distal and proximal ends of the conductive member in the insulating sheath of the bipolar guide wire is shown along lines AA and BB, respectively;

[0137] - Figure 10 The structure of the central portion of the bipolar guide wire of the present invention is shown in a cross-sectional view;

[0138] - Figure 11 The steps of simultaneously placing a valve catheter and a pacemaker electrode from outside the patient's body according to the present invention are shown in a perspective schematic diagram. DETAILED DESCRIPTION

[0139] In the following description, in the apparatus of this patent application, "distal" and "proximal" are used with reference to the body of a patient whose deteriorated native aortic valve is replaced with a prosthetic aortic valve. Thus, the distal end of the introducer is the end that is located furthest inside the patient's body during the replacement procedure.

[0140] For the sake of simplicity, the same components in the device of the present invention and the device of the prior art are marked with the same reference numerals.

[0141] It should be noted that the various components are not necessarily shown to scale.

[0142] FIG1 shows an introducer 1 for replacing a heart valve via the femoral artery.

[0143] This generally tubular introducer 1 has, between its proximal end 10 and distal end 11, a tip 12 which is extended by at least one tubular outer sheath 13 which is formed from two tubular parts 14, 15 from the proximal side to the distal side relative to insertion into the femoral artery of the patient to be operated on, i.e. from top to bottom in FIG. 1 .

[0144] The end 12 is generally equipped with a sealing valve device for hemostasis, that is, for ensuring that blood remains in the patient's blood vessels during surgery.

[0145] The tubular sheath 13 can be retractable or non-retractable to allow passage of surgical devices, such as valve catheters, as described below. The sheath 13 is constructed from a material that does not cause rejection by the body, such as silicone. Sheath 13 can be made of polytetrafluoroethylene (Teflon™) or polyurethane. Advantageously, the sheath is coated externally with a hydrophilic layer and internally with a low-friction material to facilitate sliding of surgical instruments.

[0146] The introducer 1 shown in FIG. 1 also has a flushing device 16 with a valve, usually called a “flusher”, which is used to flush the interior of the introducer with a suitable flushing liquid.

[0147] The presence of the introducer 1 in the proximal or outer region Z E All components of the sheath 13 are used to maintain the patient's body, the defined distal region Z IThe entire distal portion 15 is intended for insertion into the femoral artery of a patient.

[0148] The introducer 1 shown is, for example, an introducer commercially produced by Edwards Lifesciences under the trade name “Edwards eSheath Insertion Sheath Assembly”.

[0149] Figures 2A to 2C show a valve catheter 2 being advanced into the distal portion 14 of the tubular sheath of an introducer 1 already inserted in the femoral artery A, wherein the valve catheter 2 is composed of a guide wire 20 and a device 21, wherein the device 21 is composed of an artificial valve fixed to a radially expandable stent and an inflatable balloon for performing such expansion.

[0150] The tip of the device 21 allows easy access to a hypofunctional native aortic valve.

[0151] As shown in these figures, as the valve catheter 2 slides, the portion 15 of the tubular sheath temporarily deforms radially, forming a slight bulge 150. When the tubular sheath is not telescopic, it does not deform radially.

[0152] As shown in FIG3 , the surgeon's hand M inserts the valve catheter 2 into the introducer 1 that has been inserted into the femoral artery of the patient, with the tip 12 forming a protrusion outside the body C.

[0153] This insertion of the valve catheter 2 allows the device 21 to be brought to the site of the hypofunctional, calcified aortic valve that is to be replaced.

[0154] 3, a well-known clamp 3 called an alligator clip is clamped and fixed on the guide wire 20 of the valve catheter 2. The clamp 3 is connected to the cathode of a cardiac pacemaker (not shown) located outside the body C.

[0155] A needle (not shown) is also implanted in the subcutaneous tissue of the patient's body C. A metal wire 4 is fixed to the needle.

[0156] An alligator clip-type fixture 5 is also clamped and fixed on the metal wire 4.

[0157] The clamp 3 is connected to the anode of the pacemaker outside the body.

[0158] Therefore, when the prosthetic valve is in place of the native aortic valve to be replaced, the surgeon preliminarily performs a rapid ventricular stimulation of the left ventricle before the prosthetic valve is implanted in the true sense, ie before the balloon and thus the stent to which the valve is fixed is expanded.

[0159] To this end, an electrical signal is transmitted by the clamps 3, 5 between the cathode and the anode, the air bag acting as an electrical insulator between the two electrodes.

[0160] FIG4 shows a delivery catheter that can be inserted directly into a patient's artery without the need for an introducer. More specifically, catheter 1' has a tip 12 that is extended by an insertion sheath 13. Tip 12 has a connector 18 for inflating / deflating a balloon 7 at distal end 11, allowing expansion of a prosthetic valve (not shown).

[0161] Compared to many transfemoral aortic valve replacement surgeries, as briefly described, and in particular to the precise and delicate implantation of additional hypodermic needles and the placement and retention of connecting clamps such as crocodile clips on two separate supports, the inventors of the present invention have considered integrating the wire 4 directly into the introducer 1 or delivery catheter. This solution is described and claimed in patent application PCT / EP2016 / 057385.

[0162] While this solution has many advantages over the prior art, it suffers from a major drawback, namely the need to manufacture a dedicated introducer or delivery catheter.

[0163] Therefore, the inventors first considered not to integrate the metal wire into a dedicated introducer or delivery catheter, but to manufacture a conductive sleeve 6 that is suitable for being directly assembled around the existing introducer 1 or delivery catheter 1 ′.

[0164] This sleeve 6 of the present invention is shown in Figure 5 : It has the shape of a tube, wherein at least a portion of the outer periphery is conductive.

[0165] The conductive part is connected to an electrical connection 8 by an electric wire 7 .

[0166] The sleeve 6 can be cylindrical or truncated cone-shaped, and its shape completely fits the outer shape of the insertion sheath 13 of the introducer 1 or the delivery catheter 1'.

[0167] like Figure 6 As shown, the thickness of the sleeve 6 is typically on the order of millimeters or less, and only a small thickening is added to the sheath 13, so that when it is inserted into the artery A, its advancement is not affected.

[0168] The sleeve 6 can be made in the form of a completely conductive integral component or in the form of a component covered with a conductive coating. As the conductive material, carbon is advantageously selected.

[0169] According to an advantageous embodiment, the sleeve 6 can be designed to be elastic and thus adaptable to any size of existing introducers or delivery catheters.

[0170] In practice, the surgeon or doctor responsible for the cardiac stimulation valve replacement surgery, who is also responsible for the implantation of the cardiac stimulation and prosthetic valve, begins by installing the conductive sleeve 6 around the introducer 1 or delivery catheter. Since the installation of the conductive sleeve is very simple and easy, it can be performed by an assistant or a nurse without the need for specialized skills.

[0171] Once the sleeve 6 is fitted and positioned around the insertion sheath 13 so that it contacts either the patient's subcutaneous area or the patient's aortic valve wall, placement is complete.

[0172] Once this placement is complete, insertion of the introducer 1 or delivery catheter 1 ' fitted with the sleeve 6 can typically be performed by a surgeon.

[0173] Once the introducer 1 or delivery catheter 1 ′ is positioned in the femoral artery, the electrical connector 8 can be directly connected to the anode of an external cardiac pacemaker.

[0174] Typically, a clamp, such as the alligator clip 3 shown in Figure 3, can be clamped and fixed on the guide wire of the introducer 1 or valve catheter 1'. The clamp is connected to the cathode of a pacemaker located outside the body C (not shown).

[0175] Therefore, temporary cardiac stimulation for desired heart failure can be performed between the cathode electrically connected to the guide wire and the anode electrically connected to the sleeve 6 of the present invention.

[0176] The inventors also considered that the role of the metal wire is not to be integrated into a dedicated introducer or delivery catheter, but to use a percutaneous electrode 6'.

[0177] This electrode 6' of the present invention is shown in Figure 7 : It has an adhesive portion 60' which adheres to the skin of a human body into which the sheath is inserted, and a conductive portion 61' made of a conductive material suitable for transmitting electric current through the skin.

[0178] The conductive part 61' made of conductive material also has an electrical connection part, wherein a wire 7' is fixedly connected to a connector 8 for connecting to an electrode of an external pacemaker.

[0179] In practice, the surgeon or doctor responsible for the cardiac stimulation valve replacement surgery, who is also responsible for implanting the cardiac stimulation and prosthetic valve, begins by attaching the percutaneous electrode 6 to the patient's skin. This electrode placement can be performed, for example, in an area relative to the heart. Because placement is very simple and easy, it can be performed by an assistant or nurse without requiring specialized skills.

[0180] Once positioned, insertion of the introducer 1 or delivery catheter 1 ' may typically be performed by a surgeon.

[0181] Once the introducer 1 or catheter is positioned in the femoral artery, the electrical connector 8 can be connected directly to the anode of an external pacemaker.

[0182] Typically, a clamp, such as an alligator clip 3, can be clamped and fixed on the guide wire of the introducer 1 or valve catheter 1'. The clamp is connected to the cathode of the pacemaker located outside the body C (not shown). Figure 8 shown.

[0183] Therefore, temporary cardiac stimulation for desired heart failure can be performed between the cathode electrically connected to the guide wire and the anode electrically connected to the transcutaneous electrode 6' of the present invention.

[0184] Therefore, the inventors considered that the role of the metal wire is not to be integrated into a dedicated introducer or delivery catheter, but to be integrated into an electrically insulated bipolar guide wire 6" at its central portion, and the guide wire is always used to be inserted into the tubular sheath 13 of the introducer.

[0185] More precisely, if Figures 9 to 10 As shown, the bipolar guidewire 6" first has a metal core 60" covered with an electrically insulating sheath 61" over a central portion between the proximal end 6P" and the distal end 6D" of the guidewire.

[0186] The distal end 6D" of the metal core is adapted to come into contact with the wall of the left ventricle of the patient's heart.

[0187] In the illustrated embodiment, the distal end portion 6D" is a portion that is more flexible than the rest of the guidewire. Its flexibility allows it to coil upon contact with the left ventricle wall of the patient's heart. This ensures that the contact is both safe and non-impact, i.e., does not puncture the ventricular wall. This is in contrast to conventional electrosystolic stimulation probes, which make quasi-point contact with the wall and thus pose a risk of cardiac tamponade.

[0188] The metal core 60" is not electrically insulating over the remaining length of the guidewire.

[0189] Embedded within the electrically insulating sheath 61 ″ is a metallic coating 7 ″, with the exception of its distal end portion 70 ″ and its proximal end portion 71 ″.

[0190] Therefore, the distal portion 70″ is exposed over the entire outer circumference of the insulating sheath 71″ so as to come into contact with the subcutaneous tissue of the body or with an artery. The proximal portion 71″ is exposed over the entire outer circumference of the insulating sheath so as to be accessible from outside the body C when the guide wire is inserted into the insertion sheath 13.

[0191] Due to this structure of the bipolar guide wire 6", the proximal portion 71" of the installed conductive member 7" serves as a connector for connecting to one electrode of the cardiac pacemaker outside the body, while the metal core 60" of the bipolar guide wire serves as a connector for connecting to the other electrode of the cardiac pacemaker outside the body.

[0192] In practice, the surgeon or doctor who is in charge of the cardiac stimulation valve replacement surgery is also responsible for cardiac stimulation, implantation of the prosthetic valve, starting with the insertion of the introducer 1 or delivery catheter, which can usually be performed by the surgeon.

[0193] Therefore, the bipolar guide wire 6 ″ of the present invention is inserted into the insertion sheath 13 of the introducer 1 or the delivery catheter 1 ′.

[0194] Once these positions are complete, the proximal portion 71" of the conductive member 7" can be directly connected to the anode of an external cardiac pacemaker. In other embodiments, such as Figure 11 As shown, a clamp 5, such as an alligator clip 3, can be clamped and fixed on the conductive proximal portion 71".

[0195] The clamp 3 is connected to an anode of a cardiac pacemaker not shown and located outside the body C.

[0196] Typically, a clamp, such as an alligator clip 5, is clamped onto the metal core 60" of the guide wire 6". The clamp 5 is connected to the cathode of the pacemaker, not shown, located outside the body C. This configuration is shown in FIG. Figure 11 .

[0197] Therefore, temporary cardiac stimulation for achieving desired heart failure can be performed between a cathode electrically connected to the metal core 60" of the guide wire 6" of the present invention and an anode electrically connected to the distal portion 71" of the conductive member 7" of the guide wire 6".

[0198] The present invention can be based on patent application PCT / EP2016 / 057385 for percutaneous heart valve replacement, maintaining all the inherent advantages of the present invention, and also having the advantage of being able to be implemented on any existing introducer or delivery catheter, since one can choose:

[0199] - a single conductive sleeve 6 should be fitted onto the existing introducer or catheter and an electrical connection on the guidewire should be pre-connected before insertion into the artery of the patient to be operated on; or

[0200] - a single transcutaneous electrode 6' is adhered to the patient's skin for heart failure and a connector is connected over the guidewire during replacement surgery;

[0201] During a replacement procedure, only two electrical connections are made on the guide wire 6".

[0202] The invention is not restricted to the exemplary embodiments described; in particular, features of the exemplary embodiments described can be combined with one another in other exemplary embodiments that are not shown.

[0203] Other embodiments may be implemented, and other modifications may be made, without departing from the scope of the present invention.

[0204] References

[0205] [1]: "Registry of Transcatheter Aortic–Valve Implantation in High–Risk Patients", Gilard et al; the New England Journal of Medicine: pp1705-1715

[0206] [2]: “Left Ventricular Guidewire Pacing to Simplify Aortic Balloon Valvuloplasty”, Susanne Navarini et al; Catheterization and Cardiovascular Interventions 73: pp426-427 (2009)

[0207] [3]: “A novel approach for transcoronary pacing una porcine model”, Roland Prodzinsky et al; Journal of Invasive Cardiology 24(9): pp451-455 (2012)

[0208] [4]: "Optimizing of Transcoronary Pacing in a Porcine Model", K enstantin M. Heinroth, et al, Journal of Invasive Cardiology 21, pp634-638 (2009)

Claims

1. An assembly for percutaneous replacement of a heart valve, characterized in that: It has: an introducer (1) having at least one tubular insertion sheath (13) for insertion into an artery of a body (C) and for passing a surgical device; - at least one guide wire (6"), referred to as a bipolar guide wire, for insertion into a tubular insertion sheath (13) of an introducer for advancing an artificial heart valve for replacing a heart valve, the guide wire (6") having a metal core (60") covered with an electrically insulating sheath (61") in a central portion between the proximal and distal ends of the guide wire, the metal core being electrically non-insulated over the remainder of the length of the guide wire, the electrically insulating sheath housing a conductive member (7"), the distal portion (70") of the conductive member The conductive member is exposed on at least a portion of the outer periphery of the electrically insulating sheath so as to contact the subcutaneous tissue of the body or the artery, and the proximal portion (71") of the conductive member is exposed on at least a portion of the outer periphery of the electrically insulating sheath so as to be accessible from outside the body (C) when the guide wire is inserted into the insertion sheath (13), the proximal portion (71") serves as a connection to one electrode of a cardiac pacemaker outside the body, and the metal core (60") of the bipolar guide wire serves as a connection to the other electrode of the external cardiac pacemaker.

2. A percutaneous replacement heart valve assembly, characterized in that: It has: A delivery catheter (1') for delivering the valve, the delivery catheter having at least one tubular insertion sheath (13) for insertion into an artery of the body; - at least one guide wire (6"), called a bipolar guide wire, for insertion into a tubular insertion sheath (13) of a delivery catheter for advancing an artificial heart valve for replacing a heart valve, the guide wire (6") having a metal core (60") covered with an electrically insulating sheath in a central portion between a proximal end (6P") and a distal end (6D") of the guide wire, the metal core being electrically non-insulated over the remaining length of the guide wire, the electrically insulating sheath housing a conductive member (7"), the distal portion (7D) of the conductive member being electrically conductive. 0") is exposed on at least a portion of the outer periphery of the electrically insulating sheath so as to contact the subcutaneous tissue of the body or the artery, the proximal portion (71") of the conductive member is exposed on at least a portion of the outer periphery of the electrically insulating sheath so as to be accessible from outside the body (C) when the guide wire is inserted into the insertion sheath (13), the proximal portion (71") serves as a connection to one electrode of a cardiac pacemaker outside the body, and the metal core (60") of the bipolar guide wire serves as a connection to the other electrode of the external cardiac pacemaker.

3. The assembly for percutaneous replacement of a heart valve according to claim 1 or 2, characterized in that: The electrode of the pacemaker connected to the conductive member (7") housed in the electrically insulating sheath of the guide wire (6") is the anode, while the electrode connected to the metal core (60") of the guide wire (6") is the cathode.

4. The assembly for percutaneous replacement of a heart valve according to claim 1 or 2, characterized in that: The metallic conductive member (7") is a metal layer embedded in the electrically insulating sheath (61"), except for the exposed portions of the conductive member, namely the distal portion (70") and the proximal portion (71").

5. The percutaneous replacement heart valve assembly according to claim 2, wherein: The non-electrically insulated distal end (6D") of the metal core (60") of the guidewire, which is intended to contact the wall of the left ventricle of the patient's heart, is a more flexible portion than the rest of the guidewire.

6. The assembly for percutaneous replacement of a heart valve according to claim 5, wherein: The more flexible distal end (6D") is adapted to coil upon itself when it comes into contact with the wall of the left ventricle of the patient's heart.

7. The assembly for percutaneous replacement of a heart valve according to claim 1 or 2, characterized in that: The distal portion (70") of the conductive member is connected to an electrical connector which is itself used to connect to an electrode of a cardiac pacemaker outside the body.

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