Device for occluding the left auricle of the heart

Abstract

The present invention relates to a device for occluding the auricle of the heart, the device comprising an anchoring part (11) connected to a closure part (5), the anchoring part (1) and the closure part (5) each being able, independently of one another, to transition from a retracted position to at least one deployed position. The invention is characterised in that the anchoring part (1) has a front end that comprises at least one circular arc portion (11) capable of fitting into the bottom of the auricle without any risk of damage thereto, the ends of the at least one portion each being extended by an anchoring arm (13; 14; 15; 16) that has a free end, wherein the arm extends towards the closure part (5).

Description

[0001] Description

[0002] Title of the invention: DEVICE FOR OCCLUDING THE LEFT ATRIAL OF THE

[0003] HEART

[0004] Technical field

[0005] The present invention relates to a device for occluding the left atrium of the heart.

[0006] Prior art

[0007] The human heart has two atria, also called auricles.

[0008] Each atrium has a small pouch forming a cul-de-sac that protrudes from the ventricle and is also called the auricle. The auricle is an embryonic remnant that does not participate in the functioning of the heart. However, its role is major in certain pathologies, particularly atrial fibrillation.

[0009] The irregular rhythm of the atria that characterizes atrial fibrillation causes a slowing of blood circulation. This slowing can lead to the formation of clots, which are most often located in the left atrium. The clot can migrate and cause a stroke or peripheral embolism.

[0010] One of the treatments for atrial fibrillation is the administration of an anticoagulant.

[0011] This blood-thinning treatment is easy to use and helps prevent blood clots. However, it exposes patients to a risk of bleeding.

[0012] Elderly people in particular, who can no longer take anticoagulant treatment, often have to undergo an operation to occlude the auricle to prevent the formation and migration of clots.

[0013] Document EP 3 340 890 B1 describes a device for occluding the left atrium of the heart. In this document, the device described comprises two elements, an anchoring element and a sealing element, both of which are umbrella-shaped. The anchoring element, which is retracted upon insertion into the left atrium, has a circular plate-shaped end that is housed in the bottom of the atrium. When the flat end is housed in the bottom of the atrium, it is anchored in the wall. The sealing part, which is located outside the atrium, allows its occlusion.

[0014] Such a device is difficult to produce because it has several assembled parts.

[0015] Furthermore, since the auricle has a very thin membrane, it is sometimes pierced during implantation, which can be detrimental with a risk of fatal hemorrhage. Surgery is then required. In addition, the insertion of this type of device is delicate because it cannot be easily moved once it is inserted into the auricle.

[0016] Furthermore, the morphology of the auricle is variable and depends on each individual. There are auricles that are more or less deep. Similarly, the shape of the auricle is very variable; there are auricles shaped like cauliflower, cactus, sock, anvil, and chicken wing. Depending on the shape of the auricle, it is sometimes difficult to place the end of the anchoring part in the bottom of the auricle without damaging it.

[0017] Subject of the invention

[0018] The present invention aims to improve the situation described above.

[0019] An object of the present invention is to provide a left atrial appendage occlusion device which reduces the risk of perforation of the atrial appendage.

[0020] Another object of the present invention is to provide a device for occluding the left atrium of the heart, which can be placed at the bottom of the atrium and not near its opening.

[0021] Another aim of the invention is to propose a device for occluding the left atrium of the heart, which adapts to all auricle morphologies.

[0022] Another aim of the invention is to propose a device for occluding the left atrium of the heart, which can reposition itself spontaneously or be repositioned by a practitioner.

[0023] The present invention relates to a device for occluding the auricle of the heart, comprising an anchoring portion connected to a sealing portion, said anchoring portion and said sealing portion each being able, independently of one another, to move from a retracted position to at least one deployed position.

[0024] According to the invention, said anchoring part has a front end which comprises at least one portion in the shape of an arc, the ends of said at least one portion each being extended by an anchoring arm, said arm extending towards said closure part.

[0025] Advantageously, said anchoring part has a front end which comprises at least one portion in the shape of an arc of a circle capable of being housed in the bottom of the auricle without risking damaging it.

[0026] Advantageously, the ends of said at least one circular arc portion are each extended by an anchoring arm, at least one anchoring arm having a free end, preferably each anchoring arm having a free end.

[0027] Advantageously, at least one anchoring arm extends towards said closure portion, preferably each anchoring arm extends towards said closure portion. For the purposes of the present invention, the term “front end of the anchoring portion” means the end which is directed towards the inside of the auricle and which is furthest from the closure portion. The front end being in the form of an arc of a circle or formed of several arcs of a circle, each convex side of which is directed towards the wall of the auricle, it can thus be housed in the bottom of the auricle without risking damaging it. In other words, the convex side is directed towards the wall so that by geometric definition the chord of said arc is between it and the closure portion.

[0028] In addition, the anchoring part is thus simple to produce; the device is therefore robust and inexpensive to produce. It can easily be made, for example, of biocompatible alloy, easily sterilized and durable over time once implanted in the patient's body.

[0029] Also, the conformation of each of the arcuate portions can be changed over time by the flexibility of the structure of the device.

[0030] The front end has at least one arcuate portion in its retracted position and in its deployed position so as not to risk piercing the wall of the auricle when placing the device.

[0031] Advantageously, at least one arc-shaped portion is able to fit into the bottom of the auricle without risking damaging it.

[0032] Advantageously, at least one arc-shaped portion is capable of at least partially fitting the bottom of the auricle without risking damaging it.

[0033] Advantageously, each circular arc portion has two ends, each of which is extended by an anchor arm. Each anchor arm is therefore connected by one of its ends to the respective circular arc portion and has a free end.

[0034] Preferably, each anchoring arm extends towards said closure part.

[0035] Advantageously, whatever the embodiment, the arms and the arc-shaped portion form a single piece.

[0036] Advantageously, said front portion comprises two intersecting or overlapping arcuate portions and said device comprises two pairs of arms which extend said arcuate portions. In this case, each pair is connected by an arcuate portion. The two pairs of arms may be arranged in two planes, which may be perpendicular. The arcuate portions may overlap or form a single piece.

[0037] Whatever the embodiment, the arms and the arcuate portion(s) are preferably symmetrical with respect to a longitudinal axis of the device. Advantageously, the distance separating the two ends of the arms of the same pair (opposite arms) is equal to or greater than 20 mm and equal to or less than 35 mm, when the anchoring part is in the deployed position.

[0038] Regardless of the embodiment, the arms may, in the deployed position, form an inflection point with the arcuate portion. At least one part of at least one arm may, in the deployed position, fit the auricle.

[0039] Advantageously, whatever the embodiment, there is no point of inflection between the arms and the arcuate portion. The arcuate portion and the arms form an arcuate in the deployed position, so as to at least partially match the shape of the auricle.

[0040] Regardless of the embodiment, said arms may have barbs along their length and / or at their free end, oriented towards the end of the arms. These barbs allow the anchoring part to be retained in the auricle. They are inserted into the thickness of the auricle wall. Their orientation allows, by adjusting the spacing of the arms, to remove them from the auricle wall without damaging the latter. The barbs are arranged on the external face of the arm so as to be able to come into contact with the auricle wall.

[0041] Advantageously, according to a particular embodiment, said anchoring part and said closure part are connected by connecting means elastically deformable according to their length; said connecting means are flexible and / or mounted mobile in rotation on said closure part. The connecting means can be a wire, a cable, an extensible rod or a bundle of extensible cables. These means form a sort of spring which can also bend or pivot at its end secured to the closure part. It is thus possible to extend and bend them on either side of the axis of symmetry of the device of the invention; they return to their initial length and their rectilinear shape, when the force exerted on them ceases. These connecting means make it possible to firmly press the closure part against the external edge of the opening of the auricle, in order to ensure its closure.They also allow the displacement of the obturation part when the latter has entered the auricle and it is therefore necessary to remove it to be able to correctly place the device of the invention. The connecting means advantageously extend along the axis of symmetry of the device of the invention. Their flexibility or the possibility of pivoting at the level of their end fixed on the obturation part allows the device of the invention to be positioned in the bottom of the auricle, whatever the shape of the latter.

[0042] According to a particular embodiment, combinable with each of the aforementioned embodiments, the device of the invention comprises means for retracting said arms.

[0043] The embodiment of these means for retracting said arms is not limited. Thus, according to a particular embodiment of the retraction means, they comprise elastically deformable wires capable of following the extension of the connecting means along their length, said wires each connecting the free end of one of said arms to said closure portion. The wires are preferably extensible along their length and of the same length as the connecting means.

[0044] When fitting the device of the invention, the practitioner can thus reposition it by retracting the anchoring part again and then deploying it again. The process can be repeated several times if necessary. The practitioner can also completely retract the device in order to extract it from the auricle. The wires can extend the same length as the connecting means.

[0045] Thus, when the connecting means are stretched to their maximum, the deformation of the sealing part will pull on the wires and thus pull the arms towards the axis of symmetry of the device (towards the inside of the anchoring part and therefore towards the connecting means).

[0046] The sealing portion is not limited according to the invention. It may be a disc, a plate, a pocket or a section of cylinder. It may be solid or have openings. It may contain on its surface or release a cell growth factor. It is preferably elastically deformable. The sealing portion is advantageously made of a non-cytotoxic and non-cytostatic material and preferably capable of being colonized by cells.

[0047] According to a particular embodiment variant of the closure part, combinable with each of the aforementioned embodiments, the closure part comprises or is formed of a three-dimensional mesh (single or double wire). This mesh facilitates the colonization of the cells. It also allows the attachment of the wires of said retraction means of said arms. It also makes the closure part elastically deformable.

[0048] Preferably, the sealing part is then in the form of a mesh trap in the form of a double oblong disc forming a flexible and foldable pocket.

[0049] Whatever the embodiment of the device of the invention, it advantageously comprises means for attachment to a guide cable, which are arranged either on the face of said closure part which is opposite said anchoring part in the unfolded position or at the end furthest from said anchoring part in the retracted position.

[0050] These attachment means may comprise a portion of a sphere or a threaded rod. The guide cable comprises at its end an element allowing it to be secured to and detached from the attachment means. This may be a clamp or a threaded rod, for example. The present invention also relates to a kit for fitting a device for occluding the cul-de-sac of the auricle of the heart, comprising the device of the invention and possibly a sheath such as a catheter, and / or a guide cable.

[0051] Figures

[0052] The present invention, its characteristics and the various advantages that it provides will appear better on reading the following description of an embodiment presented by way of illustrative and non-limiting example and which refers to the appended drawings in which:

[0053] [Fig. 1]: Figure 1 represents a schematic view in longitudinal section of a particular embodiment of the invention, equipped with means for retracting the arms, in the deployed position, at the outlet of the sheath of the catheter used for its installation;

[0054] [Fig. 2]: Figure 2 shows a schematic longitudinal sectional view of the embodiment of Fig. 1 implanted in a sock-shaped auricle; and

[0055] [Fig. 3]: Figure 3 shows a schematic longitudinal sectional view of the embodiment of Fig. 1, implanted in a chicken wing-shaped auricle; and

[0056] [Fig. 4]: Figure 4 represents a schematic view in longitudinal section of the same particular embodiment of the invention as in Figure 1, equipped with means for retracting the arms, in the retracted position, into the sheath of the catheter used for its installation.

[0057] Detailed description

[0058] With reference to Fig. 1, an embodiment of the invention will be described.

[0059] In the example described here, the device comprises an anchoring part 1 which has two end portions 11A and 11B, each formed from an arc of a circle.

[0060] In the example described here, the anchoring part therefore comprises four arms 13, 14, 15 and 16 which extend the two end portions 11A and 11B and extend on either side of the connecting rod 3.

[0061] In the example described here, the anchoring part 1 is symmetrical with respect to the connecting rod 3. The arms 13 and 15 form with the end part 11B an arc of a circle without an inflection point. The same is true for the arms 14 and 16 and the end portion 11A.

[0062] In the example described here, the connecting rod 3 is elastically deformable along its length and flexible; it can be curved.

[0063] The arcuate portions 11A and 11B form a single piece in this embodiment; the two arcuate portions 11A and 11B do not overlap. Referring to Fig. 1, a first end 31 of the connecting rod 3 is fixed to the arcuate portions 11A and 11B, on the concave face of the arc portions of the anchoring part 1. The second end 33 of the rod 3 is connected to the sealing part 5. The sealing part 5 may, for this purpose, be covered with a cell growth factor. In Fig. 1, the sealing part 5 is also in the deployed position. It is formed of an elastically deformable mesh.

[0064] Referring to Fig. 1, the four arms 13, 14, 15 and 16 have the same length.

[0065] In this example, each arm 13, 14, 15 and 16 has on its external surface, a plurality of barbs 17, the free end of which is oriented towards the second end 33 of the rod 3.

[0066] In Fig. 1, the obturation part 5 comprises on its external face 51, opposite the anchoring part 1, means 53 for attaching to the end 71 of a guide cable 7, which can move in the sheath 100 of a catheter and exit it if necessary.

[0067] These attachment means 53 are formed in the present case, of a hemispherical concave portion. The end 71 of the laying cable comprises a sphere which cooperates with the concave portion of the attachment means 53.

[0068] The closure portion 5 is formed from an elastically deformable three-dimensional mesh. In the deployed position, the closure portion 5 forms a portion of a cylinder or a cone formed from the three-dimensional mesh folded back on itself in a manner possibly different from the folding adopted in the sheath 100.

[0069] Still with reference to Fig. 1, the device comprises means 6 for retracting the arms 13, 14, 15 and 16. The retracting means 6 comprise wires 61, 62, 63, and 64 which each connect the free end of one of the arms 13, 14, 15 and 16 with the closure part 5. The wires 61, 62, 63 and 64 are hooked onto the closure part 5, close to the second end 33 of the connecting rod 3. They are hooked around the second end 33. The wires 61, 62, 63 and 64 are also elastically deformable.

[0070] Fig. 2 shows the device of the invention inserted into a sock-shaped auricle and obstructing it. The arcuate portions 11A and 11B are housed at the bottom of the auricle and at least partly fit the wall by their convex side. The arms 13, 14, 15 and 16 being flexible, they easily hook into the wall of the auricle.

[0071] The connecting rod 3 being flexible and elastically deformable, it lengthens to allow the anchoring part 1 to be placed in the auricle while the obturation portion 5 is placed outside the latter.

[0072] Fig. 3 shows the device of the invention inserted into a chicken wing-shaped auricle and obstructing it. It can be seen that thanks to the flexibility and the elongation capacity of the connecting rod 3, the arcuate portions 11A and 11B are housed at the bottom of the auricle, matching at least in part the walls with their convex side, and the arms 13, 14, 15 and 16 are attached to the auricle sac while the obturation portion 5 is located outside the latter and blocks the opening. It is noteworthy that the arms 14 and 16 match the walls of the auricle at least over part of their length, the arm 14 having a point of inflection with the associated arcuate portion. The arms 13 and 15 can have the same behavior in the volume of the auricle (not shown in Figure 3).

[0073] Fig. 4 shows the same embodiment of the invention as in Fig. 1, but for which the device is in the retracted position in its sheath 100. The device comprises an anchoring part 1 which has two end portions 11A and 11B, each formed by an arc of a circle. The anchoring part therefore comprises four arms 13, 14, 15 and 16 which extend the two end portions 11A and 11B and extend on either side of the connecting rod 3 towards the closing part 5.

[0074] The arcuate portions 11A and 11B form a single piece in this embodiment; the two arcuate portions 11A and 11B do not overlap. A first end 31 of the connecting rod 3 is fixed to the arcuate portions 11A and 11B, on the concave face of the arc portions of the anchoring part 1. The second end 33 of the rod 3 is connected to the sealing part 5, which is in the retracted position.

[0075] In this retracted position, and in this same embodiment as in Fig. 1, the closure part 5 is still formed of an elastically deformable mesh, which consists of a mesh trap in the form of a double oblong disc forming a flexible and foldable volume.

[0076] Thus, when moving from the retracted position to the deployed position, this double oblong disc illustrated in Fig. 4 comes out of the sheath 100 and reconfigures into a portion of a cylinder or a cone formed from the three-dimensional mesh illustrated in Fig. 1.

[0077] The device comprises means 6 for retracting the arms 13, 14, 15 and 16. The retracting means 6 comprise wires 61, 62, 63, and 64 which each connect the free end of one of the arms 13, 14, 15 and 16 with the closure part 5. The wires 61, 62, 63 and 64 are hooked onto the closure part 5, close to the second end 33 of the connecting rod 3. They are hooked around the second end 33. The wires 61, 62, 63 and 64 are also elastically deformable.

[0078] Still with reference to Fig. 4, the closure part 5 comprises at its end 52 furthest from the anchoring part 1, in its position retracted into the sheath 100, attachment means 53. Once the device is deployed, this end 52 is found on the external face 51 of the closure part 5, opposite the anchoring part 1 in the deployed position illustrated in Figs. 1 to 3,

[0079] These attachment means 53 make it possible to connect the occlusion device to the end 71 of a guide cable 7, which can move in the sheath 100 of a catheter and exit it if necessary. These attachment means 53 are formed in the present case, of a hemispherical concave portion. The end 71 of the laying cable comprises a sphere which cooperates with the concave portion of the attachment means 53.

[0080] The method of placing or removing the device of the invention will now be described with reference to Figs. 1 to 4. The device of the invention is inserted in the retracted position into the sheath 100 of the catheter. The device is removably attached to the free end 71 of the guide cable 7. The practitioner performs a transseptal puncture via the femoral vein. He introduces the sheath 100 of the catheter containing the device of the invention and the guide cable 7 into the opening made and follows the path of the catheter by radioscopy and echocardiography. The practitioner places the opening of the catheter in the left auricle. He places the arcuate portions 11a and 11B in the bottom of the auricle. These portions being in an arc of a circle whose convex sides are directed towards the wall of the auricle, they at least partially match the shape of the bottom of the auricle (cul-de-sac) without risk of perforation of the latter.

[0081] By pushing the guide cable 7, the practitioner allows the occlusion device of the invention to come out of the sheath 100 of the catheter. The anchoring part 1 then deploys into the auricle. The arms 13, 14, 15 and 16 move apart from each other; the device is then in the deployed position. The barbs 17 hook into the wall of the auricle. If the obturation part 5 is located outside the auricle, the practitioner releases it so that it also deploys. The connecting rod 3 being elastically deformable, it presses the obturation part 5 against the external edge of the opening of the auricle as shown in Figs. 2 and 3.

[0082] If the anchoring part 1 is incorrectly positioned, the practitioner then pulls on the guide cable 7. In doing so, the obturation part 5 deforms; the deformation of the obturation part 5 pulls on the wires 61, 62, 63 and 64 causing the arms 13, 14, 15 and 16 to fold towards the connecting rod 3. Due to the retraction of the arms 13, 14, 15 and 16 towards the connecting rod 3, the barbs 17 come out of the wall of the auricle; by actuating the guide cable 7, the practitioner can then move the device of the invention inside the auricle and reposition it correctly. He can also completely retract the device into the sheath 100.

[0083] The installation of the device of the invention is completed by the separation of the end 71 of the guide cable 7 and the attachment means 53, either by unscrewing or by opening the clamp. The catheter is then removed from the patient's body. Advantageously, it is possible to leave the sheath 100 for introducing the device in place in the auricle in order, for example, to facilitate its removal and the installation of a new device if necessary.

[0084] The materials are not limiting of the invention. The rod 3, the closure part 5 and the anchoring part 1 may be made of a shape memory material, or comprise such a material, for example.

[0085] It should be noted that this detailed description relates to a particular embodiment of the present invention, but that in no case does this description have any limiting character with respect to the subject of the invention; on the contrary, its objective is to remove any possible imprecision or misinterpretation of the claims which follow.

[0086] It should also be noted that the reference signs placed in parentheses in the following claims are in no way limiting; these signs have the sole purpose of improving the intelligibility and understanding of the following claims as well as the scope of the protection sought.

Claims

Claims 1. Device for occluding the auricle of the heart, comprising an anchoring part (1) connected to a sealing part (5), said anchoring part (1) and said sealing part (5) each being able, independently of one another, to move from a retracted position to at least one deployed position, characterized in that said anchoring part (1) has a front end which comprises at least one portion in the shape of an arc (11) capable of being housed in the bottom of the auricle without risking damaging it, the ends of said at least one portion each being extended by an anchoring arm (13; 14; 15; 16) having a free end, said arm extending towards said sealing part (5).

2. Device according to claim 1, characterized in that said front portion comprises two intersecting or overlapping arcuate portions, and in that said device comprises two pairs of arms which extend said arcuate portions.

3. Device according to any one of the preceding claims, characterized in that the distance separating the two free ends of the opposite arms is equal to or greater than 20 mm and equal to or less than 35 mm, when the anchoring part is in the deployed position.

4. Device according to any one of the preceding claims, characterized in that said anchoring arms (13; 14; 15; 16) have along their length and / or at their free end, barbs (17) oriented towards said closure part.

5. Device according to any one of the preceding claims, characterized in that said anchoring part (1) and said closure part (5) are connected by connecting means (3) elastically deformable along their length and in that said connecting means are flexible and / or mounted to move in rotation on said closure part (5).

6. Device according to any one of the preceding claims, characterized in that it comprises means for retracting said arms (13; 14; 15; 16).

7. Device according to claim 6, characterized in that said retraction means comprise elastically deformable wires (61; 62; 63; 64) capable of following the extension of said connecting means along their length and in that said wires each connect the free end of one of said arms to said closure portion (5).

8. Device according to any one of the preceding claims, characterized in that said closure part (5) comprises or is formed from a three-dimensional mesh.

9. Device according to any one of the preceding claims, characterized in that it comprises means (53) for attachment to a guide cable (7), which are arranged on the face of said closure part (5) which is opposite said anchoring part (1).

10. Kit for installing a device for occluding the atrial appendage of the heart, comprising the device according to any one of the preceding claims and optionally a catheter and / or a guide cable (7).

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