Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
  • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
  • A61F2/2418—Scaffolds therefor, e.g. support stents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2/07—Stent-grafts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
  • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

• the invention relates to implantable medical devices and more particularly relates to medical endoprostheses used in cardiology or in vascular surgery. And the invention relates more specifically to an endoprosthesis for the replacement of the aortic root by the endovascular route with proximal sealing under the aorta.
• An organism (human or animal) with a heart and an aortic root can be affected by several pathologies such as type A aortic dissection, aneurysm disease, pseudo aneurysms, infectious pathologies.
• the aortic root is part of the aorta and an aortic valve located at the level of the heart. From the aortic valve emerges the aorta hence the denomination 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 according to the aortic arch.
• An object of the invention is to have a vascular endoprosthesis allowing endovascular replacement of the aortic root without recourse to open heart surgery.
• the invention proposes, according to a first aspect, a device for replacing an aortic root mobile between a deployed configuration and a folded configuration, said device comprising:
• an intraventricular stent comprising a proximal part and a distal part, said intraventricular stent being flared from the proximal part towards the distal part so that when the device is deployed in the ventricle it is maintained in position in the ventricle;
• 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.
• the aortic stent extends from the intraventricular stent and includes a tubular portion
• the aortic valve assembly is disposed 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 for connections 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 part of the intraventricular stent;
• the intraventricular stent and the aortic stent are made of a mesh covered with a biocompatible material, such as pericardium.
• the invention provides, according to a second aspect, an assembly comprising a device according to the first aspect of the invention and a casing, preferably in 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.
• the replacement device being in a folded configuration consisting of a single piece, it allows complete replacement of the aortic root easier than with prostheses in several pieces since this replacement can be done in one operation;
• the aortic valve assembly that can be placed in several places (in situ or in the ascending aorta) allows adaptation to different clinical situations.
• FIG. 1 illustrates a replacement device according to a first embodiment of the invention
• FIG. 2 illustrates a device for replacing an aortic root according to a first embodiment
• Figure 3 illustrates the device of Figure 2 deployed in an aorta
• Fig. 4 illustrates a view of an intraventricular stent of a device according to the first embodiment or the second embodiment
• FIG. 5 illustrates a device for replacing an aortic root according to a second embodiment
• Figure 6 illustrates the device of Figure 4 deployed in an aorta
• FIG. 7 illustrates a replacement device according to a third embodiment
• Figure 8 illustrates the device of Figure 7 deployed in an aorta
• FIG. 9 illustrates a sectional view of a replacement device according to the invention.
• FIG. 1 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 at the level of an aortic ring which constitutes a junction between the heart 101 and the aorta 102. From the aortic valve 107 emerges the aorta 108 hence the name of this zone by aortic root 102. In this zone, located at the level of the heart 101 emerge the right coronaries 104 and left 103 and l ascending aorta 105 extending along the aortic arch 106.
• prosthesis hereinafter aortic root replacement device
• aortic root replacement device which will be described is intended to extend from the heart to an area above the coronary arteries.
• distal and proximal is defined in relation to the aortic valve.
• the prosthesis constitutes a self-expanding implantable medical device which can adopt 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.
• the prosthesis is intended to be implanted in a patient by means of a catheter through various vascular accesses (femoral, axiliary, humeral, carotid, transapical, etc.).
• the replacement device which will be described is movable between a deployed configuration and a folded configuration.
• the folded position allows the practitioner to implant the device.
• an aortic root replacement device A, B, C comprises an intraventricular stent 1; an aortic valve assembly 7 and an aortic stent 5 extending from the intraventricular stent 1.
• 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.
• a one-piece aortic root replacement device is obtained when it is implanted, which limits the sealing problems inherent in the junction of several prosthesis portions when it comes to replacing the root. aortic.
• this avoids having to connect the various elements in situ in the patient's body.
• the replacement of the aortic root can be performed endovascularly, which avoids major surgeries.
• the intraventricular stent 1 is intended to be deployed in the ventricle below the aortic valve 107 and advantageously comprises a proximal portion 11 and a distal portion 12 between which the stent 1 is flared so that when deployed in the heart 101 (more precisely its ventricle) it is held in position against the internal walls 201, 202 of the ventricle.
• the distal part 12 of the stent 1 is therefore located below the aortic valve 107 in the heart and more precisely in the flushing chamber of a cavity of the heart 101.
• the distal portion 12 includes a distal lumen 13 and the proximal portion 11 includes a proximal lumen 14 and the stent 1 is flared between the proximal and distal portions.
• 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. into the ventricle and be held in position in the ventricle.
• the stent 1 therefore has a deployed configuration in the form of a skirt which prevents the device A from "exiting" from the ventricular. Additionally, the stent 1 in this deployed configuration provides proximal subvalvular sealing at the aortic annulus and ventricular outflow chamber.
• the intraventricular stent 1 consists of a mesh (for example metal) covered with a biocompatible material such as pericardium. Of course, other materials can be considered. In this way, this material forms a wall which presents a blood tightness and provides a certain rigidity to the stent in addition to that provided by the mesh. From then on, it forms a conduit for the blood.
• the aortic stent 5 extends from the aortic valve assembly 7 and consists of advantageously of a first part 51 widening out from the intraventricular stent 1 and of a tubular part 52 extending from the first part 51. The first part 51 of the stent 5 is tapered.
• the section of the aortic stent 5 widens out from the intraventricular stent 1 and has a variable section on this first part while the tubular part 52 itself has a constant section.
• the aortic stent 5 then has an hourglass shape with the intraventricular stent 1.
• the aortic stent 5 is designed to, when it becomes tubular after the flared portion 51, be in contact with the inner wall of the aorta just above the coronaries.
• 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 presents a blood tightness and provides a certain rigidity to the stent in addition to that provided by the mesh. From then on, it forms a conduit for the blood.
• the aortic valve assembly 7 is connected to the intraventricular stent 1 by means of suture or glue. This set of aortic valve 7 makes it possible to replace the aortic valve while maintaining a natural tricuspid conformation.
• the aortic valve assembly 7 can either extend from the proximal lumen or be inserted inside the intraventricular stent 7.
• the aortic valve assembly 7 therefore includes three flaps which open or lower to allow blood to pass into the ventricle (not shown).
• the aortic valve assembly 7 is made of a bio-compatible material such as pericardium.
• 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 a larger diameter and using some overlap. It is this second module that will allow connection to the supraortic trunks.
• 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 area above coronaries, in order to exclude the aortic root and the aorta from the circulation of blood ascending native patient (in particular reducing the blood pressure exerted on the native walls).
• Figure 2 illustrates a replacement device A for an aortic root according to a first embodiment
• Figure 3 illustrates the replacement device according to this first embodiment in position in an aorta 108.
• the aortic valve assembly 7 is disposed at the junction between the intraventricular stent 1 and the aortic stent 5. Further, the aortic valve assembly 7 is connected to the proximal portion 11 of the intraventricular stent 1. which extends from this proximal part 11.
• the aortic stent 5 comprises in its tubular part 52 at least two means for connecting the device to the coronary arteries here constituted by internal branches 2.
• At least two internal branches 2 make it possible to perfuse the coronaries 104, 103.
• three internal branches 2 are provided. In this case, this makes it possible to ensure when positioning device A that the coronaries are well perfused. Indeed, as one can understand the device must be correctly oriented with respect to the coronaries.
• providing three branches makes it possible to overcome the difficulties of orienting device A, each valve sinus being perfused, in particular when the latter must be deployed in an emergency situation.
• Such internal branches 2 facilitate the perfusion of the coronaries.
• Branches or windows can be pre-loaded by a guide passing through them from the inside out for easier access.
• the intraventricular stent 1 may include a notch 17 in order to avoid intracardiac contacts and compressions with the conduction elements of the heart in the heart. aim to limit the appearance of conductive disorders post-procedure.
• the notch 17 is disposed around the periphery of the proximal portion 14 of the intraventricular stent.
• Figure 5 illustrates a replacement device B of an aortic root according to a second embodiment and Figure 6 illustrates the replacement device according to this second embodiment in position in an aorta 108.
• This device B according to the second embodiment differs from the device A according to the first embodiment in that the aortic stent comprises two or three means of connection of the device to the coronary arteries here constituted by windows 3 which are practical openings in the aortic stent 5. These windows are preferably arranged in the tapered part of the stent 5.
• the windows 3, like the internal branches 2, make it possible to perfuse the coronaries and to facilitate the positioning of the prosthesis in the aorta.
• Figure 7 illustrates a replacement device C of an aortic root according to a third embodiment and Figure 8 illustrates the replacement device according to this third embodiment in position in an aorta 108.
• This device C according to the third embodiment differs from the devices according to the first and second embodiment (devices A and B) in that the aortic valve assembly 7 is arranged in the high position (after the aortic root) in the part tubular 52 of the "new ascending aorta" intraventricular stent 5.
• This arrangement of the aortic valve applies to cases with windows or limbs.
• the branches (or windows) to the coronaries of this device can be positioned outside or through the aortic valve assembly 7.
• Figure 9 illustrates a sectional view of the device A, B, C in an aorta 108.
• the device according to the first, the second mode or the third embodiment can advantageously be used with an envelope of felt, 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 wrap increases the seal in the distal portion of the device.
• the device can advantageously be implemented with an external bag with the tapered part 51 which can be filled on demand with a polymeric substance making it possible to increase the distal sealing zone.
• the aortic stent 5 extends from the intraventricular stent 1 and includes a first part 51 extending from the intraventricular stent 1 and a tubular part 52 extending from the first part 51.
• the latter is made up of several meshes which have different mechanical properties.
• radial force is meant a resistance of the mesh in a radial direction of the device with respect to its longitudinal axis.
• the different parts are substantially cylindrical at least in pieces so that they all include an axis of revolution from which the radial direction is defined.
• the first part 51 of the stent 5 consists of a first mesh
• the tubular part 52 consists of a second mesh
• the intraventricular stent 1 consists of a third mesh
• the first mesh, the second mesh and the third mesh having different mechanical properties.
• the first mesh advantageously has a radial force greater than the radial force of the second mesh, the first mesh being configured to provide the flexibility necessary for the curvature of the aortic root in which the first part 51 is intended to be positioned.
• the first mesh comprises a Z mesh.
• the second mesh is advantageously configured to make it possible to obtain different lengths of the tubular part 52. It is preferably a spiral mesh. Such a conformation is adaptable and allows with a suitable launcher to compress or stretch the stent 5, thus making it possible to obtain different lengths for the tubular part 52 in order to best adapt to the anatomy of the patient.
• the third mesh is advantageously a tighter mesh than the first and second meshes in order to ensure a seal in the area where it is placed.
• This is a tight quadrangular mesh. Indeed, in this area, it is essential to have a strong seal.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Gastroenterology & Hepatology (AREA)
• Pulmonology (AREA)
• Prostheses (AREA)

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• 2020
  • 2020-05-20 FR FR2005214A patent/FR3110385B1/fr active Active
• 2021
  • 2021-05-20 US US17/926,820 patent/US20230200984A1/en active Pending
  • 2021-05-20 WO PCT/FR2021/050916 patent/WO2021234314A1/fr not_active Ceased
  • 2021-05-20 EP EP21733495.2A patent/EP4153095A1/de active Pending

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