Aortic root replacement device
The vascular endoprosthesis addresses the challenge of aortic root replacement by providing a single-piece, endovascular solution with secure sealing and coronary perfusion, reducing the need for open heart surgery and associated complications.
Patent Information
- Application Number
- FR2020005214
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2020-05-20
- Publication Date
- 2025-07-11
- Estimated Expiration
- 2040-05-20
AI Technical Summary
Current methods for replacing or repairing the aortic root often require open heart surgery, which is associated with significant complications and high mortality rates, particularly for elderly patients with acute type A dissection, making them ineligible for traditional surgical interventions.
A vascular endoprosthesis designed for endovascular replacement of the aortic root, comprising an intraventricular stent with a flared design and an aortic stent forming a unitary assembly, allowing deployment via a catheter and providing a proximal and distal seal, with features like internal branches and windows for coronary perfusion and a biocompatible covering.
Enables aortic root replacement without open heart surgery, ensuring secure sealing and coronary perfusion, reducing complications and mortality risks, and facilitating easier deployment through a single-piece prosthesis design.
Smart Images
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Abstract
Description
Title of the invention: Aortic root replacement device GENERAL TECHNICAL FIELD
[0001] The invention relates to implantable medical devices and more particularly to medical endoprostheses used in cardiology or vascular surgery. And the invention relates more specifically to an endoprosthesis for the replacement of the aortic root by endovascular route with proximal subaortic sealing. STATE OF THE ART
[0002] An organism (human or animal) having a heart and an aortic root can be affected by several pathologies such as type A aortic dissection, aneurysmal disease, pseudoaneurysms, infectious pathologies.
[0003] These infections may require repair or replacement of the aortic root, which is usually performed by open heart surgery with the need for extracorporeal circulation.
[0004] The aortic root is a part of the aorta and an aortic valve located at the level of the heart. From the aortic valve emerges the aorta, hence the name of this area by aortic root. In this area, located at the level of the heart, emerge the right and left coronaries and the ascending aorta which extends along the aortic arch.
[0005] Surgery to replace or repair the aortic root is often an open surgery which, however, has significant complication and mortality rates. Currently, 20% of patients with acute type A dissection are declared ineligible for surgery, specifically elderly patients.
[0006] These patients may, however, be eligible for aortic root replacement using endovascular surgery. PRESENTATION OF THE INVENTION
[0007] An object of the invention is to have a vascular endoprosthesis allowing endovascular replacement of the aortic root without recourse to open heart surgery.
[0008] To this end, the invention proposes, according to a first aspect, a device for replacing a mobile aortic root between a deployed configuration and a folded configuration, said device comprising: . - an intraventricular stent comprising a proximal portion and a distal portion, said intraventricular stent being flared from the proximal portion towards the distal portion so that when the device is deployed in the ventricle it is held in position in the ventricle; . - an aortic valve assembly; . - an aortic stent extending from the intraventricular stent; the intraventricular stent, the aortic valve assembly and the aortic stent forming a unitary assembly in the collapsed configuration and in the deployed configuration.
[0009] The invention, according to the first aspect, is advantageously supplemented by the following characteristics, taken alone or in any of their technically possible combinations: . - the aortic stent extends from the intraventricular stent and includes a tubular portion; . - the aortic valve assembly is arranged in the tubular part of the aortic stent; . - the aortic valve assembly is connected to the proximal portion of the intraventricular stent, said aortic valve assembly being disposed at the junction between the intraventricular stent and the aortic stent; . - the aortic stent comprises at least two internal branches, preferably three internal branches intended to connect the device to the coronary arteries. . - the aortic stent comprises at least two windows, preferably three windows, intended to connect the device to the coronary arteries. . - the aortic stent comprises means of connection to other prostheses intended to be inserted into the aorta of a patient; . - the intraventricular stent may comprise a notch formed at the periphery of the proximal portion of the intraventricular stent; . - the intraventricular stent and the aortic stent are made of a mesh covered with a biocompatible material, such as pericardium.
[0010] The invention proposes, according to a second aspect, an assembly comprising a device according to the first aspect of the invention and an envelope, preferably made of felt, said envelope being intended to be wrapped around the aorta of a patient and the aortic stent when said device is deployed in the aorta of a patient.
[0011] The advantages of the invention are multiple: - The replacement device being in a folded configuration made up of a single piece, it allows a complete replacement of the aortic root easier than with multi-piece prostheses since this replacement can be done in a single operation; . - The presence of a tapered area at the level of the ascending aorta and the flared part at the level of the ventricle ensures a good proximal and distal seal between the replacement device and the walls of the aorta to be treated; - The presence of two or three windows or branches allows maintaining coronary flow to ensure aortic valve function, avoiding problems of prosthesis orientation; . - The aortic valve assembly can be placed in several locations (in situ or in the ascending aorta) allowing adaptation to different clinical situations. PRESENTATION OF THE FIGURES
[0012] Other characteristics, aims and advantages of the invention will emerge from the following description, which is purely illustrative and non-limiting, and which must be read in conjunction with the appended drawings in which: [Fig. 1]
[0013] [Fig.l] illustrates a replacement device according to a first embodiment of the invention; [Fig. 2]
[0014] [Fig.2] illustrates a device for replacing an aortic root according to a first embodiment; [Fig. 3]
[0015] [Fig.3] illustrates the device of [Fig.2] deployed in an aorta; [Fig. 4]
[0016] [Fig.4] illustrates a view of an intraventricular stent of a device according to the first embodiment or the second embodiment; [Fig. 5]
[0017] [Fig.5] illustrates a device for replacing an aortic root according to a second embodiment; [Fig. 6]
[0018] [Fig.6] illustrates the device of [Fig.4] deployed in an aorta; [Fig. 7]
[0019] [Fig.7] illustrates a replacement device according to a third embodiment; [Fig. 8]
[0020] [Fig.8] illustrates the device of [Fig.7] deployed in an aorta; [Fig. 9]
[0021] [Fig.9] illustrates a sectional view of a replacement device according to the invention.
[0022] Throughout the figures, similar elements bear identical references. DETAILED DESCRIPTION
[0023] [Fig.l] illustrates, schematically, the anatomy 100 of the aorta 108 which comprises an aortic root 102 which comprises an aortic valve 107 located at the level of the heart 101. From the aortic valve 107 emerges the aorta 108, hence the name of this area by aortic root 102. In this area, located at the level of the heart 101, emerge the right coronary arteries 104 and left 103 and the ascending aorta 105 extending along the aortic arch 106.
[0024] In the following, an aortic root prosthesis intended to replace the aortic valve and a part of the ascending aorta (up to an area located upstream of the aortic arch) is considered.
[0025] In particular, the prosthesis (hereinafter aortic root replacement device) which will be described is intended to extend from the heart to an area above the coronary arteries. The notion of "distal" and "proximal" is defined in relation to the aortic valve.
[0026] The prosthesis constitutes a self-expanding implantable medical device capable of adopting a final position within the aorta which is different from its initial position (before deployment), and which is also different from its position at rest.
[0027] In particular, the prosthesis is intended to be implanted in a patient by means of a catheter via various vascular accesses (femoral, axiliary, humeral, carotid, transapical, etc.).
[0028] Thus, the replacement device to be described is movable between a deployed configuration and a folded configuration. The folded position allows the practitioner to implant the device.
[0029] In relation to Figures 2 to 8, a device for replacing an aortic root A, B, C comprises an intraventricular stent 1; an aortic valve assembly 7 and an aortic stent 5 extending from the intraventricular stent 1.
[0030] Advantageously, the intraventricular stent 1, the aortic valve assembly 7 and the aortic stent 5 form a unitary assembly when the device is in the folded configuration but also in the deployed configuration. In this way, a one-piece aortic root replacement device is obtained when it is implanted, which limits the sealing problems inherent in joining several prosthesis portions when replacing the aortic root. Also, this avoids having to connect the different elements in situ in the patient's body. In addition, the replacement of the aortic root can be carried out by endovascular means, which avoids major surgeries.
[0031] The intraventricular stent 1 is intended to be deployed in the ventricle below the aortic valve 107 and advantageously comprises a proximal part 11 and a distal part 12 between which the stent 1 is flared so that when it is deployed in the heart 101 (more precisely its ventricle) it is held in position against the internal walls 201, 202 of the ventricle.
[0032] The distal portion 12 comprises a distal lumen 13 and the proximal portion 11 comprises a proximal lumen 14 and the stent 1 is flared between the proximal and distal portions.
[0033] In other words, it widens from the proximal lumen towards the distal lumen. Indeed, the proximal lumen having a diameter smaller than that of the distal lumen then, when the stent 1 is inserted into the ventricle when it is deployed (see [Fig.2]), the flared part 15 will deploy to take its place in the ventricle and be held in position in the latter. The stent 1 therefore has a deployed configuration in the form of a skirt which prevents the device A from “coming out” of the ventricle. In addition, the stent 1 in this deployed configuration provides a proximal subvalvular seal at the level of the aortic annulus and the ventricular outflow chamber.
[0034] The intraventricular stent 1 is made of a mesh (for example metallic) covered with a biocompatible material such as pericardium. Of course, other materials can be considered. In this way, this material forms a wall which is impervious to blood and provides a certain rigidity to the stent in addition to that provided by the mesh. Therefore, it forms a conduit for the blood. The aortic stent 5 extends from the aortic valve assembly 7 and advantageously consists of a first part 51 widening from the intraventricular stent 1 and a tubular part 52 extending from the first part. In other words, the section of the aortic stent 5 widens from the intraventricular stent 1 and has a variable section on this first part while the tubular part 52 has a constant section. The aortic stent 5 then has an hourglass shape with the intraventricular stent 1.
[0035] Such a shape makes it possible to ensure the sealing of the prosthesis with the wall of the aorta. Indeed, the aortic stent 5 is designed to, when it becomes tubular after the flared part 51, be in contact with the internal wall of the aorta just above the coronaries.
[0036] As with the intraventricular stent 1, the aortic stent 5 is made of a mesh covered with a biocompatible material such as pericardium. Of course, other materials can be considered. In this way, this material forms a wall which is impervious to blood and provides a certain rigidity to the stent in addition to that provided by the mesh. Therefore, it forms a conduit for the blood.
[0037] The aortic valve assembly 7 is connected to the intraventricular stent 1 by means of suture or glue. This aortic valve assembly 7 makes it possible to replace the aortic valve while maintaining a natural tricuspid conformation. In particular, the aortic valve assembly 7 can either extend from the proximal lumen or be inserted inside the intraventricular stent 7.
[0038] The aortic valve assembly 7 therefore comprises three flaps which open or lower to allow blood to pass into the ventricle (not shown).
[0039] Further, the aortic valve assembly 7 is made of a biocompatible material such as pericardium.
[0040] The device A, B, C can be connected to other prostheses, endoprosthesis 8 for example. The connection between the prostheses is made by adding another module of larger diameter and using a certain overlap. It is this second module which will allow the connection to the supra-aortic trunks.
[0041] The device A, B, C, taking into account both its hourglass shape at the level of the coronaries and its flared shape at the level of the ventricle, makes it possible to obtain a seal at the level of the ventricle but also at the level of the zone above the coronaries, with the aim of excluding the aortic root and the native ascending aorta of the patient from the circulation of blood (in particular reducing the blood pressure which is exerted on the native walls).
[0042] [Fig.2] illustrates a replacement device A of an aortic root according to a first embodiment and [Fig.3] illustrates the replacement device according to this first embodiment in position in an aorta 108.
[0043] According to this embodiment, the aortic valve assembly 7 is arranged at the junction between the intraventricular stent 1 and the aortic stent 5. Furthermore, the aortic valve assembly 7 is connected to the proximal portion 11 of the intraventricular stent 1 which extends from this proximal portion 11.
[0044] Also, the aortic stent 5 comprises in its tubular part 52 two internal branches 2 allowing the coronaries 104, 103 to be perfused. Advantageously, three internal branches 2 are provided. In this case, this makes it possible to ensure, when positioning the device A, that the coronaries are properly perfused. Indeed, as can be understood, the device must be correctly oriented relative to the coronaries. Thus, providing three windows or branches makes it possible to overcome the difficulties of orientation of the device A, each sinus of valves being perfused, in particular when the latter must be deployed in an emergency situation. Such internal branches 2 facilitate the perfusion of the coronaries.
[0045] The branches or windows may be pre-loaded by a guide passing through them from inside to outside allowing easier access.
[0046] As illustrated in [Fig.4], in a manner complementary to each of the embodiments (A, B, C) the intraventricular stent 1 may comprise a notch 17 in order to avoid intracardiac contact and compression with the conduction elements of the heart in order to limit the occurrence of post-procedure conduction disorders. The notch 17 is arranged on the periphery of the proximal part 14 of the intraventricular stent.
[0047] [Fig.5] illustrates a replacement device B of an aortic root according to a second embodiment and [Fig.6] illustrates the replacement device according to this second embodiment in position in an aorta 108.
[0048] This device B according to the second embodiment differs from the device A according to the first embodiment in that the aortic stent 5 comprises two or three windows 3 in its tapered part. The windows 3, like the internal branches 2, allow the coronaries to be perfused.
[0049] [Fig.7] illustrates a replacement device C of an aortic root according to a third embodiment and [Fig.8] illustrates the replacement device according to this third embodiment in position in an aorta 108.
[0050] This device C according to the third embodiment differs from the devices according to the first and second embodiments (devices A and B) in that the aortic valve assembly 7 is arranged in a high position (after the aortic root) in the tubular part 52 of the intraventricular stent 5 "new ascending aorta". This arrangement of the aortic valve applies to cases with windows or branches. The branches (or windows) towards the coronaries of this device can be positioned outside or through the aortic valve assembly 7.
[0051] [Fig.9] illustrates a sectional view of the device A, B, C in an aorta 108. In this figure, the tricuspid shape of the aortic valve assembly 7 can be seen in particular.
[0052] The device according to the first, second or third embodiment can advantageously be used with a felt envelope, or resistant synthetic materials 9 wrapped around the aorta when the device A, B, C is deployed in the aorta. Such a configuration is illustrated in [Fig.6] with the device according to the second embodiment. The use of a felt envelope makes it possible to increase the sealing in the distal part of the device.
[0053] The device can advantageously be implemented from a bag external to the prosthesis at level of the terminal part of the tapered part 51 which can be filled on demand with a polymeric substance making it possible to increase the distal sealing zone.
Claims
Claims
1. A device for replacing an aortic root movable between a deployed configuration and a collapsed configuration, said device comprising . - an intraventricular stent (1) comprising a proximal portion and a distal portion, said intraventricular stent (1) being flared from the proximal portion to the distal portion so that when the device is deployed in the ventricle it is held in position in the ventricle; . - an aortic valve assembly (7); . - an aortic stent (5) extending from the intraventricular stent (1); the intraventricular stent (1), the aortic valve assembly (7) and the aortic stent (5) forming a unitary assembly in the collapsed configuration and in the deployed configuration, the aortic stent (5) comprising at least three windows or three internal branches intended to connect the device to the coronary arteries.
2. The device of claim 1, wherein the aortic stent (5) extends from the intraventricular stent (1) and comprises a tubular portion (52).
3. A device according to claim 2, wherein the aortic valve assembly is disposed in the tubular portion (52) of the aortic stent (5).
4. A replacement device according to one of claims 1 to 2, wherein the aortic valve assembly (7) is connected to the proximal portion of the intraventricular stent (1), said aortic valve assembly (7) being arranged at the junction between the intraventricular stent and the aortic stent (5).
5. Device according to one of claims 1 to 4, in which the aortic stent (5) comprises means of connection to other prostheses intended to be inserted into the aorta of a patient.
6. Device according to one of claims 1 to 4, in which the intraventricular stent (1) may comprise a notch (17) formed at the periphery of the proximal part (14) of the intraventricular stent (1).
7. Device according to one of claims 1 to 4, in which the intraventricular stent (1) and the aortic stent (5) are made of a mesh covered with a biocompatible material, such as pericardium.
8. An assembly comprising a device according to one of the preceding claims and an envelope (9), preferably made of felt, said envelope being intended to be wrapped around the aorta of a patient and the aortic stent when said device is deployed in the aorta of a patient.