Orientation catheter for treating mitral regurgitation

Abstract

The invention relates to an orientation catheter (1) which is arranged to enable the positioning and implantation, in the left atrium (2), of an implantable device (3) intended to correct a mitral insufficiency. The catheter comprises a longitudinal flexible body (4) which comprises, at a first end (5), at least one flexible element (6), preferably at least two flexible elements separate from one another, (each of) the flexible element(s) (6) being provided with a magnet Y (7), characterised in that the magnet Y (7) of the flexible element (6) is arranged to be positioned on the aortomitral continuity (8) of the aortic valve for orienting and implanting an implantable device (3) in the left atrium at the mitral valve (10) by passive magnetic action between the magnet Y (7) and the implantable device (3).

Description

[0001] GUIDANCE CATHETER FOR TREATING MITRAL REGURGITATION

[0002] The present invention relates to an orientation catheter arranged to allow positioning and therefore implantation, in the left atrium, of an implantable device, for example to correct mitral insufficiency.

[0003] Among cardiac pathologies, mitral valve disease represents a significant concern due to its impact on cardiac function and patient quality of life. Examples include conditions such as mitral regurgitation, where the valve does not close properly, allowing blood to flow back into the left atrium, and mitral stenosis, characterized by a narrowing of the valve opening that impedes normal blood flow.

[0004] To treat these pathologies, the traditional method has been to resort to surgical replacement or repair of the faulty mitral valve. This method may require a thoracotomy, where the chest is opened to allow direct access to the heart in order to insert, for example, a mechanical or biological valve prosthesis. In addition, current devices can be in the form of a ring that is inserted by open heart surgery, which has many disadvantages, particularly in terms of mortality risks. These heavy invasive techniques therefore present high surgical risks. Such an operation is also particularly debilitating for patients who require a long recovery period and extensive post-operative monitoring.

[0005] To partially overcome these drawbacks, minimally invasive approaches have been developed, such as mini-thoracotomy or thoracoscopic surgery. These techniques, which are highly operator-dependent and accessible in few hospitals, aim to reduce the size of the incision and the trauma associated with surgery, leading to a faster and less painful recovery for the patient. These techniques only slightly reduce the morbidity and mortality of mitral surgery. Generally, known devices come in the form of a kit or devices that may include several elements to be assembled in order to be functional. These known devices still present difficulties in positioning and consequently in implantation; they are often indicated for a very specific patient population and therefore do not allow the treatment of a large number of patients or a wide range of mitral pathologies.

[0006] One of the major advances in recent years has been the development of percutaneous intracardiac implants. They are introduced via a catheter, usually inserted through a vein or artery. More specifically, the device is often inserted through the femoral vein until it reaches the right side of the heart. To reach the mitral valve located on the left side of the heart, a small hole is drilled through the wall between the atria. The device is placed with the help of an instrument at the tip of the catheter and ultrasound and radiological imaging. This method is much less invasive and avoids the need for open heart surgery. The procedure is generally shorter and requires a shorter recovery time than open heart surgery. This method is particularly suitable for patients at high surgical risk and significantly reduces the risks associated with the procedure.

[0007] In practice, transcatheter implantation requires the transport of an implantable device in a confined space, such as a catheter, and then its deployment during the implantation procedure. For example, such a device may be in the form of a ring (WO 2020 / 154797) for repairing the atrioventricular valve, and on this ring is assembled a barrier that allows the passage of blood flow after the device is placed. Transcatheter clips are also available.

[0008] Unfortunately, some current devices lack precision in terms of orientation and implantation of the mitral valve implant, including any ancillary elements such as a mitral grid. The risks of postoperative complications and procedural failure remain high.

[0009] Anatomically and functionally, the mitral valve is not symmetrical. Therefore, when implants are placed through this valve at the atrioventricular orifice, it is important to properly align them with its particular and variable structure depending on the individual. Orienting and implantation of these intracardiac implants in the atrioventricular orifice and docking them to the mitral valve structures, such as the native annulus, via a main delivery catheter does not guarantee optimal implant positioning.

[0010] Document CN 1 14 983 629 relates to a medical device for treating mitral regurgitation. It is proposed to position a system using a guidance and positioning mechanism. The proposed system is to be inserted into the left atrium and each mechanism is arranged on either side of the mitral valve. Magnets are used to position the implant and allow the treatment of mitral regurgitation. Unfortunately, the proposed system remains complex to implement in terms of handling and effectiveness.

[0011] Document DE 10 2012 101877 discloses a catheter that is placed in the left atrium to treat mitral regurgitation. The proposed catheter is limited to interacting with the peripheral tissue structure during surgery.

[0012] There is therefore a need to provide a solution to facilitate the positioning and fixation of an implantable device to treat mitral regurgitation that is effective over time and easy to implement.

[0013] The object of the invention is to provide an orientation catheter which makes it possible to improve the positioning and therefore the implantation of medical devices, preferably percutaneous intracardiac implants, by providing greater precision of placement and stability, while guaranteeing greater effectiveness of the implant.

[0014] To solve this problem, the invention provides a steering catheter arranged to allow positioning and implantation, in the left atrium, of a device intended to correct, for example, mitral insufficiency, said catheter comprising a longitudinal flexible body which comprises at a first end at least one flexible element, preferably at least two flexible elements being separated from each other, characterized in that (each) said flexible element is provided with a Y magnet which is arranged to be positioned on the mitro-aortic junction (8) of the aortic valve to orient and implant an implantable device (3) in the left atrium (2) at the mitral valve (10) by passive magnetic action between said Y magnet (7) and said implantable device (3) and / or a main delivery catheter which is also provided with at least one X magnet corresponding to said Y magnet.

[0015] The orientation catheter according to the invention makes it possible to place and implant an implantable device and its main delivery catheter to correct mitral insufficiency. Indeed, there is a mitro-aortic junction (continuity), that is to say that there is no muscular separation between the aortic valve and the anterior leaflet of the mitral valve, which makes it possible to place on one side of this mitro-aortic junction the catheter according to the invention which is equipped with a Y magnet which will be placed on this mitro-aortic junction. And, on the other side of the mitro-aortic junction, in the left atrium, is located the implantable device which must be oriented and implanted at the level of the mitral valve using an X magnet or a ferromagnetic X element.

[0016] In the context of the present invention, the mitro-aortic junction is that known to the person skilled in the art and thus designates a junction between the aortic valve and the mitral valve. This junction connects the muscular and fibrous cardiac structures. When it comes to placing and implanting an implantable device to treat mitral regurgitation, a main delivery catheter can be used in the left atrium to hold, orient and implant said implantable device. In this case, the orientation catheter according to the invention will be able to communicate with the main delivery catheter and possibly with the implantable device, by passive magnetic action. In this embodiment, the main delivery catheter is preferably also provided with an X magnet corresponding to said Y magnet of said catheter according to the invention.

[0017] The orientation of said implantable device and / or of the main delivery catheter, object of the present invention, occurs by the magnetic attraction between the two catheters, or between the orientation catheter and the implant itself located on either side of the mitro-aortic junction. To this end, the orientation catheter is brought to the level of the aortic side of said junction by retrograde route through the arterial system via an arterial puncture, preferably carried out in the radial artery or in the femoral artery.

[0018] It is positioned in the aorta against the aortic valve annulus between the non-coronary valve cusp and the non-coronary sinus of Valsalva wall. In doing so, it allows magnetic interaction with the delivery catheter of the left intra-atrial implant introduced into the atrium by a trans-septal puncture of the interatrial septum via a venipuncture or any other access to the left atrium.

[0019] Specifically, the tip of the steering catheter can be placed in the bottom of the non-coronary cusp and the second end is placed in the bottom of the left coronary cusp. They are thus preferentially placed as close as possible to the aortic wall.

[0020] Thus, when the orientation catheter according to the invention is positioned so that said magnet Y rests on the mitro-aortic junction, it can communicate, by passive magnetic action, with the implantable device which will be able to be attracted by the catheter according to the invention.

[0021] The subject of the invention is therefore based on a guidance catheter (adjuvant) independent of an implantable device intended to treat mitral regurgitation, with for example, a grid and its mitral ring, or a catheter delivery system.

[0022] The subject matter of the invention provides a synergistic interaction between the steering catheter of the invention and the delivery catheter, preferably of a mitral grid with its positioning vector, and potentially with any type of implantable device located through the left atrioventricular orifice and / or in the left atrium, including the left atrial appendage.

[0023] The invention uses the anatomical relationship constituted by mitro-aortic continuity and the principle of magnetization.

[0024] In a preferred embodiment, said flexible body is (arranged to be) positioned at the mitro-aortic junction in the ascending aorta.

[0025] Preferably, said at least one flexible element, preferably at least two flexible elements, has a proximal end and a distal end, (each) said distal end (of each) of said flexible element being provided with said magnet Y.

[0026] More preferably, said at least one flexible element, preferably at least two flexible elements, more preferably at least 3 flexible elements, even more preferably at least 4 flexible elements, each has a proximal end and a distal end, (each) said distal end (of each) of said flexible element being provided with said Y magnet. This makes it easier to slide said catheter at the mitro-aortic junction and to facilitate positioning with said Y magnet. According to an advantageous embodiment, said longitudinal flexible body comprises at least 2 flexible elements, preferably at least 3 flexible elements, more preferably at least 4 flexible elements, the proximal ends of which meet at a contact point which is connected to said first end of said flexible body.This facilitates the positioning, maneuverability and implantation of an implantable device, possibly with its main delivery catheter.

[0027] According to an advantageous embodiment, when said Y magnet is positioned on the mitro-aortic junction of the aortic valve to be in the orientation and implantation position, said (each) Y magnet is arranged to attract, by passive magnetic action, a mitral implant, preferably with a main delivery catheter housed in the left atrium, to orient and implant said device at the mitral valve.

[0028] This interaction on both sides of the mitro-aortic junction makes it easy to orient, position, implant and fix the implantable device according to the invention.

[0029] Even more preferably, when the Y magnet of said orientation catheter is positioned on the mitro-aortic junction of the aortic valve to be in the orientation and implantation position, (each) said Y magnet is arranged to attract, by passive magnetic action, a main delivery catheter which is also provided with an X magnet, or a X ferromagnetic element, corresponding to said Y magnet of said flexible element of said orientation catheter to orient and implant a mitral implant at the mitral valve.

[0030] Other features of the orientation catheter according to the invention are set out in the appended claims.

[0031] The present invention also relates to an orientation system for enabling positioning and implantation, in the left atrium, of an implantable device intended, for example, to correct mitral insufficiency comprising:

[0032] A main catheter for placing a mitral implant, said main placement catheter being provided with at least one X magnet for a mitral implant and arranged to be located in the left atrium of the heart and comprising a longitudinal flexible body,

[0033] An auxiliary delivery catheter according to any one of the preceding claims, characterized in that said Y magnet of said auxiliary delivery catheter is arranged to be positioned at (on) the mitro-aortic junction of the aortic valve to attract, by passive magnetic action, said X magnet of said main delivery catheter to orient and implant a mitral implant at the mitral valve.

[0034] This allows the catheter according to the invention to be placed on one side of this mitro-aortic junction, which is equipped with a Y magnet that will be placed on this mitro-aortic junction. And, on the other side of the mitro-aortic junction, in the left atrium, is the implantable device that must be oriented and implanted at the level of the mitral valve.

[0035] The orientation catheter according to the invention comprises features that can be found on the main delivery catheter. Indeed, these 2 catheters can comprise at least one Y / X magnet. Thus, said at least one Y magnet of said orientation catheter communicates, by passive magnetic effect, with said X magnet of said main delivery catheter, which makes it possible to attract it towards the mitral valve more easily and to facilitate the implantation of a mitral implant.

[0036] According to an advantageous embodiment, the system further comprises an implantable device, preferably a mitral implant possibly accompanied by a grid, intended to correct mitral insufficiency at the level of the native mitral annulus. Preferably, said implantable device is chosen from the group comprising a mitral annulus, a mitral grid for treating mitral regurgitation, a mitral device arranged for the treatment of mitral insufficiency and combinations thereof.

[0037] Preferably, said longitudinal flexible body of said main delivery catheter comprises at a first end at least one flexible element, preferably at least two flexible elements being separated from each other, characterized in that (each) said flexible element of said main delivery catheter is provided with said magnet X or ferromagnetic element X, preferably located at a free end of said flexible element of said main delivery catheter.

[0038] According to an advantageous embodiment, said longitudinal flexible body of said main placement catheter comprises at least 2 flexible elements, the end of which, located opposite their respective free end, meets at a contact point which is connected to said first end of said flexible body of said main placement catheter.

[0039] Other features of the system according to the invention are set out in the appended claims.

[0040] The invention also relates to a method for enabling positioning and implantation, in the left atrium (2), of an implantable device (3) intended to correct mitral insufficiency, comprising the following steps: a. Placing an auxiliary delivery catheter (1) according to any one of claims 1 to 5 at the mitro-aortic junction (8) of the aortic valve, b. Introducing the main delivery catheter (14) as defined in claims 6 to 10 into the left atrium (2) of the heart, c. Orienting the main delivery catheter (14) and implanting an implantable device (3) intended to correct mitral insufficiency at the native mitral annulus by means of said auxiliary delivery catheter (1) by passive magnetic action, d. Removing said main delivery catheter (14) and said auxiliary delivery catheter (1).

[0041] All the features mentioned for the orientation catheter above apply to the auxiliary catheter for the procedure. All features can therefore be combined if necessary.

[0042] This also applies to the main delivery catheter which has been defined above in the system according to the invention.

[0043] Other features of the method are indicated in the attached set of claims.

[0044] The invention also relates to the use of the steering catheter according to the invention for treating, for example, mitral regurgitation.

[0045] It also relates to a use of the system according to the invention for treating, for example, mitral regurgitation.

[0046] The expression “orientation catheter” according to the invention may be replaced by the expression “auxiliary placement catheter”. These expressions relate to the same subject.

[0047] The expression "magnet X corresponding to said magnet Y" means that magnet X has a pole opposite that of magnet Y so as to allow a passive magnetic action, as described in the context of the present invention. Preferably, said magnet X is a ferromagnetic element. Thus, the expression "magnet X" can be replaced by "magnet X or ferromagnetic element" in the invention.

[0048] When multiple magnets are used, for example two magnets

[0049] Y magnets of the steering catheter and two X magnets of the main delivery catheter, each magnet has a corresponding magnet. For example, a magnet of the steering catheter located in the left atrium will interact, magnetically, with its corresponding magnet which is located on the mitro-aortic junction. This correspondence works like this.

[0050] The term "passive magnetic action" means that there is no external magnetic force or electrical activation of the magnet that would be applied to the steering catheter and / or the main delivery catheter.

[0051] The orientation catheter (1) according to the invention comprises characteristics that can be found on the main placement catheter (14).

[0052] References used in the context of the present invention which illustrate the subject of the invention:

[0053] (1) Guidance catheter

[0054] (2) Left atrium

[0055] (3) Implantable device

[0056] (4) Flexible body

[0057] (5) First end of the flexible body

[0058] (6) Flexible element

[0059] (7) Y magnet of the flexible element of said orientation catheter

[0060] (8) Mitro-aortic junction

[0061] (9) Guidance system

[0062] (10) Mitral valve

[0063] (1 1 ) Proximal end

[0064] (12) Distal end

[0065] (13) Contact point

[0066] (14) Main delivery catheter

[0067] (15) Flexible elements of the delivery catheter

[0068] (16) Mitral valve Other characteristics, details and advantages of the invention will emerge from the description given below, without limitation and with reference to the drawings and examples.

[0069] Figure 1 is an illustration of the steering catheter according to the invention when introduced into the body.

[0070] Figure 2 shows a top view of the mitral valve and the tricuspid valve in the presence of the orientation catheter according to the invention and a main delivery catheter.

[0071] In the figures, identical or similar elements bear the same references.

[0072] In Figure 1 is illustrated, in the left atrium 2, an orientation catheter 1 which comprises a longitudinal flexible body 4 which has at a first end 5 two flexible elements 6 separated from each other. Each flexible element 6 has a proximal end 11 and a distal end 12. Each distal end 12 of each flexible element 6 is provided with a magnet Y 7 ready to interact with the main delivery catheter 14.

[0073] The proximal ends 11 of said orientation catheter 1 meet at a contact point 13 which is connected to said first end 5 of said flexible body 4 of the orientation catheter 1.

[0074] The main delivery catheter 14 is illustrated in Figure 1 and is provided with two Y magnets located in the left atrium 2 of the heart and comprising a longitudinal flexible body 4.

[0075] Thus, said at least one magnet Y of said orientation catheter communicates, by passive magnetic action, with said magnet or ferromagnetic element X of said main placement catheter 14, which makes it possible to attract it towards the mitral valve more easily and to facilitate the implantation of a mitral implant, as illustrated in figures 1 and 2. The implantable device is in this case a mitral implant 3. It is also possible to have a mitral implant accompanied by a grid in order to implant the implant more efficiently.

[0076] The orientation catheter 1 thus provided allows positioning and implantation, in the left atrium 2, of the implant 3 by means of the main placement catheter 14 to correct mitral insufficiency.

[0077] This embodiment corresponds to a preferred embodiment of the system according to the invention which comprises:

[0078] The mitral implant 3 located in the left atrium 2,

[0079] The auxiliary delivery catheter 1, and

[0080] The main delivery catheter 14.

[0081] As illustrated, each flexible element 6 is provided with a magnet Y positioned on the mitro-aortic junction 8 of the aortic valve to orient and implant the mitral implant 3 in the left atrium 2 at the level of the mitral valve 10 by passive magnetic action between said magnet Y 7 and said implant 3 and said main delivery catheter 14 which is provided with two magnets which correspond to the opposite pole of said magnets Y.

[0082] Figure 2 illustrates a top view showing the system according to the invention, namely a main delivery catheter 14 located at the mitral valve and an auxiliary delivery catheter 1 located at the tricuspid valve.

[0083] According to this embodiment, the main delivery catheter 14 is provided with two magnets X and is located in the left atrium 2 of the heart and has a longitudinal flexible body 4. The auxiliary delivery catheter 1 comprises the same elements as those described for FIG. 1. Thus, said magnet Y 7 of said auxiliary delivery catheter 1 is positioned at the mitro-aortic junction 8 of the aortic valve to attract, by passive magnetic action, said magnet X of said main delivery catheter 14 to orient and implant a mitral implant (not shown) at the mitral valve 10.

[0084] In addition, said longitudinal flexible body 4 of said main delivery catheter 14 comprises at a first end 5 two flexible elements 6 which are separated from each other. Each flexible element 6 of said main delivery catheter 14 is provided with said magnet X, located at a free end of said flexible element 6 of said main delivery catheter 14, as shown in FIG. 2.

[0085] It can also be seen that each flexible element 6 of said longitudinal flexible body 4 of said main delivery catheter 14 comprises an end, located opposite their respective free end. It is at a contact point 13 that these ends meet, this contact point which is connected to said first end 5 of said flexible body 4 of said main delivery catheter 14. It is understood that the present invention is in no way limited to the embodiments described above and that many modifications can be made thereto without departing from the scope of the appended claims.

Claims

CLAIMS 1. A steering catheter (1) arranged to allow positioning and implantation, in the left atrium (2), of an implantable device (3) intended to correct mitral insufficiency, said catheter (1) comprising a longitudinal flexible body (4) which comprises at a first end (5) at least one flexible element (6), preferably at least two flexible elements (6) being separated from each other, characterized in that (each) said flexible element (6) is provided with a Y magnet (7) which is arranged to be positioned on the mitro-aortic junction (8) of the aortic valve to orient and implant an implantable device (3) in the left atrium (2) at the mitral valve (10) by passive magnetic action between said Y magnet (7) and said implantable device (3) and / or a main delivery catheter (14) which is also provided with at least one X magnet corresponding to said Y magnet.

2. Catheter according to claim 1, wherein said at least one flexible element (6), preferably at least two flexible elements, has a proximal end (11) and a distal end (12), (each) said distal end (12) (of each) of said flexible element (6) being provided with said Y magnet (7).

3. Catheter according to claim 1 or 2, wherein said longitudinal flexible body (4) comprises at least 2 flexible elements (6) whose proximal ends (11) meet at a contact point (13) which is connected to said first end (5) of said flexible body (4).

4. A catheter according to any preceding claim, wherein, when said Y magnet (7) is positioned on the mitro-aortic junction (8) of the aortic valve to be in the orientation and implantation position, said (each) Y magnet (7) is arranged to attract, by passive magnetic action, a mitral implant, preferably with a main delivery catheter housed in the left atrium, to orient and implant said implantable device at the mitral valve.

5. Catheter according to any one of the preceding claims, wherein, when the Y magnet of said flexible element (6) is positioned on the mitro-aortic junction (8) of the aortic valve to be in the orientation and implantation position (8), (each) said Y magnet (7) is arranged to attract, by passive magnetic action, a main delivery catheter (14) which is also provided with an X magnet corresponding to said Y magnet (7) of said orientation catheter (1) to orient and implant a mitral implant (3) at the mitral valve (10).

6. Orientation system (9) to allow positioning and implantation, in the left atrium (2), of an implantable device (3) intended to correct mitral insufficiency comprising: A main catheter (14) for placing a mitral implant, said catheter being provided with at least one magnet X for a mitral implant (3) and arranged to be located in the left atrium (2) of the heart and comprising a longitudinal flexible body (4), An auxiliary delivery catheter (1) according to any one of the preceding claims, characterized in that said Y magnet (7) of said auxiliary delivery catheter (1) is arranged to be positioned at the mitro-aortic junction (8) of the aortic valve to attract, by passive magnetic action, said X magnet of said main delivery catheter (14) to orient and implant said mitral implant (3) at the mitral valve (10).

7. System according to claim 6, further comprising an implantable device (3), preferably a mitral implant (3) optionally accompanied by a grid (3), intended to correct mitral insufficiency at the level of the native mitral annulus.

8. System according to claim 6 or 7, wherein said implantable device (3) is chosen from the group comprising a ring mitral valve, a mitral valve grid for treating mitral regurgitation, a mitral device designed for the treatment of mitral regurgitation, and combinations thereof.

9. System according to any one of claims 6 to 8, wherein said longitudinal flexible body (4) of said main delivery catheter (14) comprises at a first end (5) at least one flexible element (6), preferably at least two flexible elements (6) being separated from each other, characterized in that (each) said flexible element (6) of said main delivery catheter (14) is provided with said magnet X, preferably located at a free end of said flexible element (6) of said main delivery catheter (14).

10. System according to any one of claims 6 to 9, wherein said longitudinal flexible body (4) of said main delivery catheter (14) comprises at least 2 flexible elements (6) whose end, located opposite their respective free end, joins at a contact point (13) which is connected to said first end (5) of said flexible body (4) of said main delivery catheter (14). 1 1. A method for enabling positioning and implantation, in the left atrium (2), of an implantable device (3) intended to correct mitral insufficiency, comprising the following steps: a. Placing an auxiliary delivery catheter (1) according to any one of claims 1 to 5 at the mitro-aortic junction (8) of the aortic valve, b. Introducing the main delivery catheter (14) as defined in claims 6 to 10 into the left atrium (2) of the heart, c. Orienting the main delivery catheter (14) and implanting an implantable device (3) intended to correct mitral insufficiency at the native mitral annulus by means of said auxiliary delivery catheter (1) by passive magnetic action, d. Removing said main delivery catheter (14) and said auxiliary delivery catheter (1).

12. Use of the orientation catheter according to any one of claims 1 to 5, for treating mitral regurgitation.

13. Use of the system according to any one of claims 6 to 10, for treating mitral regurgitation.

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