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 one electrode of a heart pacemaker is integrated in the member assembled around the insertion sheath, which is inserted in the artery of the patient or in a guide wire which becomes a bipolar support for the electrode; or the cathode of an external heart pacemaker is connected to a guide wire of an artificial valve and the anode of the heart pacemaker is connected to a transcutaneous electrode which is in contact with the skin of the patient.

Description

[0001] This application is a divisional application of the invention patent application entitled "Assembly for replacing heart valves or assembly for coronary angioplasty", with an international application date of October 5, 2017, international application number PCT / EP2017 / 075362, and national application number 201780070585.6. Technical Field

[0002] This invention relates to an assembly for percutaneous heart valve replacement or coronary angioplasty, having a valve delivery catheter and, if necessary, an insertion device, commonly referred to as a "cannula".

[0003] The present invention relates in particular to improving the assistance provided by a pacemaker for replacement therapy in cases of heart failure.

[0004] Although described with reference to aortic valve replacement, the assembly of the present invention can be used as an assembly for coronary angioplasty, which may or may not require the placement of a prosthesis commonly referred to as a "stent," especially in emergency situations or complex procedures.

[0005] Similarly, although described with reference to the replacement of the aortic valve, the device of the present invention can obviously also be used to replace other heart valves, such as the tricuspid or mitral valve.

[0006] Generally, the intubator and / or delivery catheter of the device of the present invention can be inserted percutaneously into the patient's body, more precisely, through the thigh, through the aorta, through the carotid artery, or through the subclavian region. Background Technology

[0007] Well-known heart disease is closely related to the calcification and contraction of the tricuspid valve or aortic valve, which is the valve that separates the left ventricle of the heart, i.e. the aorta. It can be in the open position to allow blood to flow from the heart to other tissues of the body.

[0008] A constriction or severe constriction prevents the aortic valve from opening properly, thus causing disease, also known as calcified aortic stenosis.

[0009] The treatment for this disease involves replacing the damaged aortic valve.

[0010] The most common procedure for replacing a defective aortic valve is open-chest surgery, which involves putting the patient on cardiopulmonary bypass, temporarily stopping the heartbeat, opening the heart, performing a resection, and replacing the original valve with an artificial valve or prosthesis.

[0011] The main drawbacks of these sequential procedures are that patients require longer hospital stays, the surgeries are more complex and costly, and they are limited to a subset of patients because, in many cases, doctors and / or surgeons deem "open-heart" surgery impossible, given the patient's overall condition, especially the need for cardiac arrest and cardiopulmonary bypass, which is extremely dangerous.

[0012] To overcome this deficiency, non-invasive heart valve replacement has been proposed; however, it still requires cardiopulmonary bypass. International patent applications WO 93 / 01768 and WO 97 / 28807, and US patents US 5814097, US5370685, or US 5545214, describe known non-invasive techniques and devices using these techniques.

[0013] However, the existing technology is considered not entirely satisfactory and needs improvement.

[0014] In particular, these technologies have the following main drawbacks:

[0015] - In any case, it is required that the patient undergo cardiopulmonary bypass; however, this is difficult to implement.

[0016] - It is impossible to precisely control the diameter of the original valve resection, making it difficult to subsequently fabricate a prosthetic valve to the precise size;

[0017] - This poses a risk of calcified remnants of the original valve spreading throughout the body's tissues, potentially leading to embolism;

[0018] - There is a risk of perforation of the aortic wall or heart wall;

[0019] - There is a risk of rapid backflow of blood during the removal of the original valve.

[0020] To compensate for the shortcomings of these technologies, one approach is to implant a percutaneous aortic valve, which borrows from endovascular processing techniques by inserting a catheter into a blood vessel, such as the aorta.

[0021] Therefore, the original aortic valve, which has become dysfunctional due to calcification, is replaced with an artificial valve, avoiding the aforementioned usually arduous cardiac surgery.

[0022] Currently, artificial valves can be implanted percutaneously in different ways: via the femoral artery, which involves inserting the valve through the femoral artery all the way to the heart; or via the top of the valve; or via the aorta; or via the carotid artery; or below the clavicle, which does not require opening the heart through the chest or performing cardiopulmonary bypass.

[0023] The surgery involves placing an artificial valve (prosthesis) to recreate the full shape of a normal original aortic valve at the site of the calcified (disease-related) original aortic valve, which is replaced by the implanted prosthesis.

[0024] For this purpose, artificial valves are made from the pericardium of pigs or cows that surrounds the heart, and are pre-fixed in a radially expandable tubular metal stent. For coronary artery stents, the metal stent is assembled from shape memory materials such as nickel-titanium alloys, cobalt-chromium alloys, and stainless steel 316L wires.

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

[0026] Therefore, the surgeon slides the valve-stent assembly through the cannula or directly through the delivery catheter until the device reaches the diseased aortic valve. Then, prior to implantation, the valve-stent assembly is placed at the diseased valve by the inflation of a balloon.

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

[0028] For details, please refer to US patents US 7018406, US 7892281, US 8652202 and US 8747459.

[0029] In the strict sense of placement, rapid ventricular stimulation is necessary to temporarily stop the heartbeat for a short period of time, minimizing blood flow through the valves and avoiding or at least reducing potential embolism.

[0030] Therefore, this temporary cardiac arrest, often referred to as "heart failure," occurs when the heart stops beating at 150 to 200 times per minute, causing it to cease contracting effectively. This lowers blood pressure, mimicking tachycardia or ventricular fibrillation, and thus stabilizes the heart.

[0031] This stability of the heart allows the balloon to stabilize, thereby increasing the precision of implanting the artificial valve within seconds.

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

[0033] These electroconstriction stimulation probes have some drawbacks, which are detailed below.

[0034] First, this probe constitutes a central venous introduction, which carries an additional risk of vascular complications for a frail patient population. The French registration designation "France 2," which involves aortic valve replacement surgery, commonly known as TAVI (Transcatheter Aortic Valve Implantation), indicates a risk of serious vascular complications of 4.7%. This result is presented in publication [1] on page 1709.

[0035] Secondly, the probe is relatively rigid, so when implanted in the fragile right ventricle, whose wall is thinner than that of the left ventricle, it poses a serious risk of "cardiac tamponade," a phenomenon known to surgeons, indicating severe circulatory insufficiency that could lead to the patient's death.

[0036] Furthermore, it should be noted that this danger exists not only during the operation, i.e., when the electro-constriction probe is placed, but also after the operation, because the movement of the bedridden patient may move the existing probe, which could potentially puncture the wall of the right ventricle.

[0037] Furthermore, there is a risk of the electrical stimulation probe shifting 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 loss of capture of the electrical stimulation signal.

[0038] Therefore, the heart is no longer stimulated, and thus beats very fast, hindering the positioning of the valves or airbags.

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

[0040] Finally, the surgeon cannot ignore the additional surgical time required to place a temporary stimulation probe, as it is by no means a simple procedure.

[0041] Publication [2] proposes the advantages of ventricular stimulation of the left ventricle rather than the right ventricle, and that the procedure is performed using an external pacemaker with a guide wire, instead of a dedicated intravenous stimulation catheter.

[0042] Therefore, the embodiment proposed in this publication [2] is that the guide wire of the inflatable balloon of the support frame is used as a part that connects to the cathode of a heart pacemaker and a skin electrode or a needle inserted into the subcutaneous tissue, serving as a support for the anode of the heart pacemaker.

[0043] In cases of coronary angioplasty in pigs, the use of a guide wire with an inflatable balloon supporting a stent as a cathode connected to a pacemaker and a skin electrode or a needle inserted into the subcutaneous tissue, serving as a support for the anode of the pacemaker, has demonstrated the effectiveness of temporary cardiac stimulation with a lower stimulation voltage, as verified in publications [3] and [4].

[0044] Therefore, the advantages of the proposed embodiment are that it avoids the need to insert a special additional catheter, avoids an entrance to the heart, shortens the operation time, reduces the operation cost, and also reduces the risk of complications associated with inserting a special catheter, while providing stimulation that is as effective as transvenous stimulation.

[0045] Furthermore, compared to the right ventricular electro-systolic stimulation probes that, as previously mentioned, could lead to cardiac tamponade, the guide wire used in this technique is very stable and permanently supported on the thicker wall of the left ventricle until it serves as a guide for the forward stent-balloon-valve assembly through the valve.

[0046] Nevertheless, the technique still requires the implantation of an electrode or an additional subcutaneous needle that must be precisely positioned and held on two separate supports with alligator clip-type connecting clamps.

[0047] The inventors of this invention, in their patent application PCT / EP2016 / 057385, propose directly implanting a pacemaker electrode within an insertion sheath (cannula or delivery catheter) inserted into a patient's artery. This invention allows surgeons to more easily and quickly manipulate and implant pacemaker electrodes.

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

[0049] However, advantageously, it may have one or more solutions that can be adapted to existing intubators or catheters, i.e., those without electrodes installed in them.

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

[0051] Therefore, according to the first embodiment, the present invention relates to an assembly for percutaneous replacement of a heart valve, which has:

[0052] - A device for forming an intubator, the intubator having at least one tubular insertion sheath for insertion into an artery in the body and for allowing a surgical device, such as a delivery catheter, to pass through.

[0053] - A sleeve, adapted to be fitted around an insert sheath, the sleeve having at least a portion of its outer periphery made of a conductive material such that when the insert sheath with the sleeve fitted around it is inserted into an artery in the body, the conductive periphery of the sleeve contacts the subcutaneous tissue of the body or the artery; the sleeve also has an electrical connector that connects to an electrode of a pacemaker located outside the body;

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

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

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

[0057] - A sleeve, adapted to be fitted around an insert sheath, the sleeve having at least a portion of its outer periphery made of a conductive material such that when the insert sheath with the sleeve fitted around it is inserted into an artery in the body, the conductive periphery of the sleeve contacts the subcutaneous tissue of the body or the artery; the sleeve also has an electrical connector that connects to an electrode of a pacemaker located outside the body;

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

[0059] According to one embodiment, the electrode of the cardiac pacemaker connected to a conductive sleeve surrounding the cannula or delivery catheter is the anode, while the electrode connected to the metal portion of the guide wire is the cathode.

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

[0061] The sleeve can be constructed from a single integral component made of a conductive material such as carbon.

[0062] It can also be made of a sheath, which has a conductive coating, such as a carbon coating, on its outer periphery.

[0063] According to an advantageous embodiment, the sleeve may be resilient enough to fit onto insert sheaths of different diameters on the intubator or delivery catheter, typically the outer diameter, between 1.67 and 8 mm (between 5 and 24 French). Generally, for sheaths used in assemblies for replacing heart valves, the outer diameter may 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, comprising:

[0065] - A device for forming an intubator, the intubator having at least one tubular insertion sheath for insertion into an artery in the body and for allowing surgical devices such as delivery catheters to pass through;

[0066] - A transdermal electrode having an adhesive portion and a conductive portion made of a conductive material, the adhesive portion being for adhesion to the skin of the body into which an insert sheath is inserted, such that when the adhesive portion is adhered to the skin, the conductive portion can transmit current through the skin, the conductive portion also having an electrical connector that connects to an electrode of a pacemaker outside the body;

[0067] - At least one guide wire for insertion into the tubular inserter sheath for advancing an artificial valve for replacing a heart valve, the guide wire having a metal portion that also serves as a connector to another electrode of an external 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 for forming a delivery catheter for delivering valves, the delivery catheter having at least one tubular insertion sheath for insertion into an artery in the body;

[0070] - A transdermal electrode having an adhesive portion and a conductive portion made of a conductive material, the adhesive portion being for adhesion to the skin of the body into which an insert sheath is inserted, such that when the adhesive portion is adhered to the skin, the conductive portion can deliver current through the skin, the conductive portion also having an electrical connector that connects to an electrode of a pacemaker outside the body;

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

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

[0073] The present invention also relates to a transdermal 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 for forming an intubator, the intubator having at least one tubular insertion sheath for insertion into an artery in the body and for allowing surgical devices such as delivery catheters to pass through;

[0076] - At least one guide wire, referred to as a bipolar guide wire, is inserted into the tubular insertion sheath of an intubator for advancing an artificial valve to replace a heart valve. The guide wire has a metal core covered with an electrically insulating sheath on a central portion between the proximal and distal ends of the guide wire. The metal core is not electrically insulating along the rest of the guide wire. The electrically insulating sheath contains a conductive member, the distal portion of which is exposed on at least a portion of the outer periphery of the electrically insulating sheath to contact subcutaneous tissue or an artery. The proximal portion of which is exposed on at least a portion of the outer periphery of the electrically insulating sheath to be accessible from outside the body when the guide wire is inserted into the insertion sheath. The proximal portion serves as a connector to one electrode of an external pacemaker, while the metal core of the bipolar guide wire serves as a connector to the other electrode of an external 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 for forming a delivery catheter for delivering valves, the delivery catheter having at least one tubular insertion sheath for insertion into an artery in the body;

[0079] - At least one guide wire, referred to as a bipolar guide wire, is inserted into a tubular insertion sheath for advancing an artificial valve to replace a heart valve. The guide wire has a metal core covered with an electrically insulating sheath on a central portion between the proximal and distal ends of the guide wire. The metal core is not electrically insulating for the remainder of the guide wire. The electrically insulating sheath is covered with a conductive member. The distal portion of the conductive member is exposed on at least a portion of the outer periphery of the electrically insulating sheath to contact subcutaneous tissue or an artery. The proximal portion of the conductive member is exposed on at least a portion of the outer periphery of the electrically insulating sheath to allow access from outside the body when the guide wire is inserted into the insertion sheath. The proximal portion serves as a connection to one electrode of an external pacemaker, while the metal core of the bipolar guide wire serves as a connection to the other electrode of an external pacemaker.

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

[0081] According to an advantageous embodiment of the invention, the conductive metal component is a metal layer embedded in an insulating sheath, except for the exposed portions of the conductive component, namely the distal and proximal portions.

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

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

[0084] The present invention also relates to a bipolar guide wire for the aforementioned assembly. This bipolar guide wire has a metal core covered with an electrically insulating sheath in the central portion between the proximal and distal ends of the guide wire. The metal core is not electrically insulating for the rest of the guide wire. The electrically insulating sheath houses a conductive member, the distal portion of which is exposed on at least a portion of the outer periphery of the electrically insulating sheath, and the proximal portion of which is also exposed on at least a portion of the outer periphery of the electrically insulating sheath.

[0085] In studying the options for the solution proposed in the aforementioned patent application PCT / EP2016 / 057385, the inventors conducted research on existing solutions for cardiac stimulation.

[0086] Therefore, known stimulation electrodes specifically designed for percutaneous temporary cardiac stimulation have been tested. This technique is recommended for the treatment of symptomatic bradycardia in emergencies or for the prevention of cardiac arrhythmias accompanied by tachycardia.

[0087] However, people have not yet considered testing this electrode for use in treating heart failure.

[0088] Surprisingly, the inventors achieved effective treatment for heart failure by connecting the cathode of the external pacemaker to the guide wire of the artificial valve and the anode to a percutaneous electrode that contacts the patient's skin.

[0089] The inventors also considered mounting the metal support of one electrode of the pacemaker within a component that surrounds an insertion sheath inserted into the patient's artery. Therefore, the sleeve of this invention directly contacts the patient's artery.

[0090] Finally, the inventors considered mounting the metal support for one of the pacemakers' electrodes in the guide wire, instead of directly mounting it in the sheath inserted into the patient's artery as in the aforementioned patent application.

[0091] The bipolar guide wire of the present invention is used separately as a support for two electrical connectors that are respectively connected to the anode and cathode of an external cardiac pacemaker. Therefore, 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 electrical connector.

[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 intubator or simply a delivery catheter smaller than an intubator. In fact, valve delivery catheters do not require an intubator because they can be inserted directly into the patient's artery.

[0094] With the help of different 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, which is usually the anode of a cardiac pacemaker.

[0095] There is no longer a need to use and implant an existing electro-shrink probe, which is often referred to as a temporary probe.

[0096] Furthermore, with the help of this invention, the stimulation intensity required for heart failure is lower than that of existing solutions because the impedance of the vascular system is lower relative to subcutaneous tissue. Typically, for heart failure, the delivered current intensity can be 10 to 20 mA and the delivered voltage can be 0.5 to 10 V.

[0097] Therefore, the surgeon in charge of the operation can easily connect the electrode, usually the anode of the pacemaker, to a conductive sleeve mounted around the intubation device or delivery catheter, or a percutaneous electrode, or a bipolar guide wire, and then usually connect the other electrode, usually the cathode, to the guide wire of the valve-stent-balloon assembly or the self-retracting valve-stent assembly.

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

[0099] In addition, the inventors believe that the sleeve or percutaneous electrode or bipolar guide wire of the present invention can reduce the risk of complications associated with the placement of electroconstriction stimulation probes in the right ventricle in the prior art.

[0100] Intubation devices or delivery catheters can usually be inserted via the tip or through the femoral artery, which is especially non-invasive for frail patients.

[0101] The intubation device or delivery catheter may be fitted with a peripheral perfusion system, often referred to as a "flushing system," which is arranged to clean any blood clots that may be present from inside the intubation device or catheter.

[0102] Therefore, advantageously, for replacing aortic valve assemblies, the cannula can be a well-known cannula, such as the cannula commercially produced by Edwards Life Sciences under the trade name "Edwards eSheath Insertion Sheath Assembly".

[0103] The artificial valve can be inserted and positioned in an artery using a conventional valve catheter inserted into a cannula. Therefore, the artificial valve is in a folded position, which does not impede the insertion and sliding of the valve catheter in the cannula and then into the artery, or in the delivery catheter of the present invention and then into the artery.

[0104] Then, in the deployed position, the artificial valve is supported on the outer wall of the original heart valve and replaced in its place.

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

[0106] During the surgery, the surgeon incises and compresses the original valve, and then applies cardiac stimulation with an external pacemaker. Current flows between the cathode and anode of the pacemaker, with the cathode connected to the guide wire of the artificial valve and the anode connected to the conductive sleeve of the invention, which is mounted around the outer tubular sheath of the intubation device or delivery catheter and contacts the patient's subcutaneous tissue or the inner wall of the artery.

[0107] Simultaneously with ventricular stimulation, the artificial valve unfolds. Then, the valve catheter is withdrawn.

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

[0109] - During aortic valve replacement surgery for impaired function, it is simpler and faster to implant an electrode, typically a ventricular stimulation anode;

[0110] - It is not necessary to implant an additional subcutaneous needle as a support for the anode of the cardiac pacemaker;

[0111] - Replacement surgery for dysfunctional heart valves is short and inexpensive;

[0112] - In cases of heart failure requiring stimulation, the temporary stimulation is highly efficient because the stimulating current encounters low impedance in the vascular system, as the sleeve surrounding an intubation device or delivery catheter is in direct contact with the system, unlike prior art needles which come into contact with the patient's skin tissue, which necessarily has higher impedance;

[0113] - During the required heart failure procedure, the rigid guide (approximately 1.455 mm in diameter) provides high temporary stimulation efficiency due to its stability in the left ventricle, unlike the instability of existing electro-constriction probes placed in the right ventricle;

[0114] - Temporary stimulation can be performed with a relatively low current because the impedance of the vascular system encountered between the two electrodes of the external stimulator is low.

[0115] - There is no risk of complications associated with placing a temporary stimulation probe in the right ventricle using existing technology;

[0116] - The intubation device or delivery catheter can be used for a variety of different transcatheter aortic implantation procedures, such as replacement of the aortic valve, pulmonary valve, tricuspid valve, or mitral valve. In particular, for the replacement of a variant tricuspid valve, a technique using only a stimulation probe with a guide rail (0.89 mm in diameter) inserted into the right ventricle can be considered, as the simultaneous use of a guide rail and an electrically constricting probe is not advisable, as the inflation of the balloon or prosthetic valve can compress the probe, posing an inherent risk of stimulation interruption or probe jamming.

[0117] - It can be used in pediatric patients for valve or cardiac surgery in patients with more tachycardia and more variable hearts compared to adults. In addition, it is applicable to patients in whom femoral artery venous puncture is difficult and a right ventricular stimulation probe needs to be implanted. Finally, the right ventricular wall of young children is thin and fragile, thus increasing the risk of serious complications such as cardiac tamponade. It also applies to the populations described in publication [2];

[0118] - This invention can be used in the field of emergency and complex coronary angioplasty procedures, where temporary cardiac stimulation must be performed efficiently and very quickly. For this purpose, an intubator or delivery catheter with a sleeve of this invention avoids the time required for implanting an electrode or an additional subcutaneous needle, as is often determined during these procedures.

[0119] The only relative limitation of the sleeve, percutaneous electrode, or bipolar guide wire of this invention is that the sleeve is installed around the insertion sheath during preparation, at the start of the procedure. However, this operation is very simple and easy to perform, and can be done entirely by an assistant or nurse without requiring specialized skills.

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

[0121] Finally, the present invention relates to an assembly with an intubator or delivery catheter having a sleeve for coronary angioplasty procedures, particularly in the emergency.

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

[0123] The first application is the treatment of acute infarction, which causes conduction disorders such as extreme bradycardia or high-degree atrioventricular block. Using an intubator with the sleeve of this invention avoids the use of existing electro-constriction probes, which are not non-invasive and require a non-negligible additional implantation time.

[0124] The second scenario involves using a known milling device, such as the trade name Rotablator®, to mill calcified coronary artery lesions within the relevant coronary artery. Therefore, the use of the cannula with a sleeve of the present invention can also overcome the shortcomings of using prior art electro-systolic cardiac stimulation probes.

[0125] The third scenario involves placing a stent in a portion of the coronary artery near its origin (orifice). These areas are highly mobile relative to the surgical catheter, and these tissue structures require significant precision during stent implantation. Using the cannula with a sleeve of this invention, the stent can be kept stable before and during its placement. Attached Figure Description

[0126] Other advantages and features of the invention will be better understood from the detailed description provided with reference to the accompanying drawings, which serve as illustrative and non-limiting examples:

[0127] Figure 1 is a perspective view of a prior art cannula for insertion into the femoral artery in the groin area of ​​a patient;

[0128] Figures 2A to 2C show partial longitudinal sectional views of different sliding steps of a valve catheter in the cannula shown in Figure 1, in order to replace the original aortic valve with an artificial valve at the site of the dysfunctional aortic valve;

[0129] Figure 3 is a three-dimensional schematic diagram illustrating the placement steps of a valve catheter and a pacemaker electrode simultaneously placed outside the patient's body according to existing technology;

[0130] Figure 4 is a three-dimensional schematic diagram of a delivery catheter according to the prior art, which is used for direct insertion into a patient's artery without the need for an intubation device;

[0131] -Figure 5 This is a perspective view of a conductive sleeve according to the present invention, the sleeve being used to assemble around a prior art cannula forming device as shown in FIG1, or around a prior art delivery conduit as shown in FIG4.

[0132] - Figure 6 This is a partial longitudinal sectional view, showing Figure 5 The sleeve shown is assembled around the prior art cannula shown in Figure 1;

[0133] - Figure 7 This is a three-dimensional diagram of a percutaneous electrode, used in assemblies for percutaneous replacement of heart valves in cases of heart failure.

[0134] - Figure 8 The three-dimensional schematic diagram illustrates the steps of simultaneously placing a valve catheter and a pacemaker electrode from outside the patient according to the present invention.

[0135] - Figure 9 This is a perspective view of the bipolar guide wire of the present invention, used in an assembly for percutaneous replacement of a heart valve to achieve cardiac fibrillation.

[0136] - Figure 9A and 9B Is buried in Figure 9 The cross-sectional views along AA and BB are shown at the distal and proximal ends of the conductive member in the insulating sheath of the bipolar conductor, respectively.

[0137] - Figure 10 The structure of the central portion of the bipolar guide wire of the present invention is shown in cross-section.

[0138] - Figure 11 The steps for simultaneously placing a valve catheter and a pacemaker electrode from outside the patient according to the present invention are illustrated in a three-dimensional schematic diagram. Detailed Implementation

[0139] In the following description, in the device of this patent application, "distal" and "proximal" are used with reference to the patient's body, where the patient's dysfunctional primary aortic valve is replaced by an artificial aortic valve. Therefore, the distal end of the cannula is the end located at the innermost part of the patient's body during the replacement surgery.

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

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

[0142] Figure 1 shows the cannula 1 for replacing a heart valve via the femoral artery.

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

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

[0145] The tubular sheath 13 may be retractable or non-retractable to allow passage of surgical devices such as valve catheters, as described later. The sheath 13 is constructed of a material that will not cause rejection by the body, such as silicone. The sheath 13 may be made entirely of polytetrafluoroethylene (PTFE). Alternatively, it can be made of polyurethane material. The sheath is advantageously coated with a hydrophilic layer on the outside and a layer of material with a low coefficient of friction on the inside to facilitate the sliding of surgical instruments.

[0146] The intubator 1 shown in Figure 1 also has a flushing device 16 with a valve, commonly referred to as a "flushing device", which is used to flush the interior of the intubator with a suitable flushing fluid.

[0147] The presence of cannula 1 in the proximal or external region Z E All components for holding the sheath 13 outside the patient's body, defining the distal region Z. I The entire distal portion 15 is used for insertion into the patient's femoral artery.

[0148] The intubator 1 shown is, for example, the "Edward eSheath Insertion Sheath Assembly" commercially produced by Edwards Life Sciences.

[0149] Figures 2A to 2C show a valve catheter 2 being advanced into the distal portion 14 of the tubular sheath of a cannula 1 already inserted in the femoral artery A. The valve catheter 2 consists of a guide wire 20 and a device 21, which consists of an artificial valve and an inflatable balloon. The artificial valve is fixed to a radially expandable stent, and the inflatable balloon is used to perform this expansion.

[0150] The tip of device 21 allows easy access to the dysfunctional primary aortic valve.

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

[0152] As shown in Figure 3, the surgeon's hand M inserts the valve catheter 2 into the catheter 1 that has already been inserted into the patient's femoral artery, 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 defunctionalized calcified aortic valve that should be replaced.

[0154] Typically, as shown in Figure 3, a known clamp 3, called an alligator clip, is clamped and fixed to the guide wire 20 of the valve catheter 2. This clamp 3 is connected to the cathode of a 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 5 is also clamped and fixed to the metal wire 4.

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

[0158] Therefore, when the artificial valve is in the location of the original aortic valve to be replaced, the surgeon performs rapid ventricular stimulation of the left ventricle before implanting the artificial valve in the strict sense, that is, before the balloon inflates and the stent fixed to the valve inflates.

[0159] Therefore, the electrical signal is transmitted between the cathode and anode by clamps 3 and 5, and the airbag acts as an electrical insulator between the two electrodes.

[0160] Figure 4 shows a delivery catheter that can be directly inserted into a patient's artery without the need for an intubation device. More precisely, catheter 1' has a tip 12, which is extended by an insertion sheath 13. The tip 12 has a connector 18 for inflating / deflating a balloon 7 at the distal end 11, allowing a prosthetic valve (not shown) to expand.

[0161] Compared to many transfemoral aortic valve replacement surgeries, as briefly described, and particularly to the precise and delicate implantation of an additional subcutaneous needle and the placement and retention of connecting clamps such as alligator clips on two separate supports, the inventors of this invention have considered directly housing the metal wire 4 within the cannula 1 or the delivery catheter. This solution is described and claimed in patent application PCT / EP2016 / 057385.

[0162] While this solution has many advantages over existing technologies, it has a major drawback: the need to manufacture specialized intubation devices or delivery catheters.

[0163] Therefore, the inventors first considered that the function of the metal wire was not to be assembled into a special intubator or delivery conduit, but to manufacture a conductive sleeve 6 that was suitable for direct assembly around an existing intubator 1 or delivery conduit 1'.

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

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

[0166] The sleeve 6 can be cylindrical or truncated. Its shape perfectly matches the outer shape of the insertion sheath 13 of the intubator 1 or delivery catheter 1'.

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

[0168] The sleeve 6 can be made as a single, fully conductive component, or as a component coated with a conductive coating. Carbon is advantageously chosen as the conductive material.

[0169] According to an advantageous embodiment, the sleeve 6 can be designed to be flexible, thus adaptable to any size of existing intubation device or delivery catheter.

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

[0171] Once the sleeve 6 is assembled and positioned around the insert sheath 13, touching either the patient's subcutaneous area or the patient's aortic valve wall, placement is complete.

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

[0173] Once the cannula 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 pacemaker.

[0174] Typically, a clamp, such as the alligator clip 3 shown in Figure 3, is used to clamp and secure the guide wire of the cannula 1 or the valve catheter 1'. This clamp is connected to the cathode of a pacemaker located outside the body C (not shown).

[0175] Therefore, the temporary cardiac stimulation required for 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 function of the metal wire was not to be assembled into a special intubation device 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' and a conductive portion 61' made of a conductive material, the adhesive portion 60' being adhered to the human skin into which the sheath is inserted, and the conductive portion 61' being adapted to transmit current through the skin.

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

[0179] In practice, the surgeon or physician responsible for cardiac stimulation and valve replacement surgery, who is also responsible for cardiac stimulation and prosthetic valve implantation, begins by adhering the percutaneous electrode 6 to the patient's skin. This electrode placement can, for example, be performed 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 placement is complete, insertion of the intubator 1 or delivery catheter 1' can usually be performed by a surgeon.

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

[0182] Typically, a clamp, such as an alligator clip 3, is used to secure the guide wire of the cannula 1 or valve catheter 1'. This clamp is connected to the cathode of a pacemaker (not shown) located externally to the body C. This configuration is as follows... Figure 8 As shown.

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

[0184] Therefore, the inventors considered that the function of the metal wire was not to be assembled into a dedicated intubation device or delivery conduit, but rather to be assembled into an electrically insulated bipolar guide wire 6" in its central part, the guide wire being always used for insertion into the tubular sheath 13 of the intubation device.

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

[0186] The distal end 6D of the metal core is used to contact the left ventricular wall of the patient's heart.

[0187] In the illustrated embodiment, the distal end 6D" is a more flexible portion than the rest of the guide wire, allowing it to coil itself when it comes into contact with the left ventricular wall of the patient's heart. This ensures that the contact is both safe and non-impact, i.e., it does not puncture the ventricular wall, unlike prior art electro-constriction stimulation probes, which make point-like contact with the wall, thus posing a risk of cardiac tamponade.

[0188] The 60" metal core is not electrically insulated for the rest of the guide wire.

[0189] A metallic coating 7 is embedded within the electrical insulating sheath 61", except for the distal portion 70" and the proximal portion 71".

[0190] Therefore, the distal portion 70" is exposed over the entire outer periphery of the insulating sheath 71" to contact the subcutaneous tissue of the body or an artery. The proximal portion 71" is exposed over the entire outer periphery of the insulating sheath so that it can be accessed from outside the body 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 one electrode of the pacemaker located outside the body, while the metal core 60" of the bipolar guide wire serves as a connector for the other electrode of the pacemaker located outside the body.

[0192] In fact, the surgeon or physician responsible for the heart stimulation and valve replacement surgery is also responsible for the heart stimulation and implantation of the prosthetic valve. The procedure, which begins with the insertion of the cannula or delivery catheter, 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 cannula 1 or delivery catheter 1'.

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

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

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

[0197] Therefore, the desired temporary cardiac stimulation for heart failure can be achieved 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] This invention, based on patent application PCT / EP2016 / 057385 for percutaneous heart valve replacement, retains all the inherent advantages of the invention and also has the advantage of being able to be implemented on any existing cannula or delivery catheter, because:

[0199] - A single conductive sleeve 6 should be fitted onto the existing cannula or catheter, and an electrical connector on the guide wire should be pre-connected before its insertion into the artery of the patient to be operated on; or

[0200] - A single percutaneous electrode 6' is adhered to the patient's skin for heart failure, and during replacement surgery, a connector is attached to the guideline;

[0201] - During the replacement surgery, only two electrical connectors are connected on the guide wire 6".

[0202] The present invention is not limited to the embodiments described; in particular, the features of the embodiments can be combined with each other in other embodiments not shown.

[0203] Other embodiments and modifications may be implemented without departing from the scope of the 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 “Records of Transcatheter Aortic Valve Implantation in High-Risk Patients”, Gilard et al; 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 Pacinguna Porcine Model», Roland Prodzinsky et al; Journal of Invasive Cardiology 24(9): pp451-455 (2012) “A novel approach for transcoronary pacinguna porcine model», Roland Prodzinsky et al; Journal of Invasive Cardiology 24(9): pp451-455 (2012)

[0208] [4]:«Optimizing of Transcoronary Pacingina Porcine Model», K nstantin / M. Heinroth, et al, Journal of Invasive Cardiology 21, pp634-638 (2009) “Optimization of Transcoronary Pacingina Porcine Model”, K / nstantin / 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 the following characteristics: - A device for forming an intubator (1), the intubator having at least one tubular insertion sheath (13) for insertion into an artery in the body (C) and for allowing surgical devices such as delivery catheters to pass through; - A transdermal electrode (6') having an adhesive portion (60') and a conductive portion (61) made of a conductive material, the adhesive portion being for adhesion to the skin of the body into which an insert sheath is inserted, such that when the adhesive portion is adhered to the skin of the body, the conductive portion can transmit current through the skin, the conductive portion also having electrical connectors (7,8) that are connected to an electrode of a pacemaker outside the body; - At least one guide wire (20) for insertion into the tubular insert sheath (13) of the cannula for advancing an artificial valve for replacing a heart valve, the guide wire (20) having a metal portion that also serves as a connector to another electrode of an external pacemaker.

2. An assembly for percutaneous replacement of a heart valve, characterized in that, It has the following characteristics: - A device for forming a delivery catheter (1') for delivering a valve, the delivery catheter having at least one tubular insertion sheath (13) for insertion into an artery in the body; - A transdermal electrode (6') having an adhesive portion (60') and a conductive portion (61) made of a conductive material, the adhesive portion being for adhesion to the skin of the body into which an insert sheath is inserted, such that when the adhesive portion is adhered to the skin, the conductive portion can transmit current through the skin, the conductive portion also having electrical connectors (7,8) connected to an electrode of a pacemaker outside the body; - At least one guide wire (20) for insertion into the tubular insert sheath (13) of the delivery catheter for forward delivery of an artificial valve for replacing a heart valve, the guide wire (20) having at least one metal portion which also serves as a connector to another electrode of an external pacemaker.

3. The percutaneous heart valve replacement assembly according to claim 1 or 2, characterized in that, The electrode of the cardiac pacemaker connected to the percutaneous electrode (6') is the anode, while the electrode connected to the metal part of the guide wire (20) is the cathode.

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