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
  • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
• • 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
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/02—Inorganic materials
  • A61L27/04—Metals or alloys
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/28—Materials for coating prostheses
  • A61L27/34—Macromolecular materials
• • 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
  • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
• • 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
  • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2220/0008—Fixation appliances for connecting prostheses to the body
  • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
• • 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
  • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2230/0063—Three-dimensional shapes
  • A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
• • 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
  • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2230/0063—Three-dimensional shapes
  • A61F2230/0073—Quadric-shaped
  • A61F2230/0078—Quadric-shaped hyperboloidal
• • 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
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0069—Sealing means
• • 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
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0069—Sealing means
  • A61F2250/007—O-rings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2430/00—Materials or treatment for tissue regeneration
  • A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves

Definitions

• Anchoring device for a prosthetic heart valve Anchoring device for a prosthetic heart valve.
• the field of the invention is that of the design and manufacture of medical devices intended to be implanted in the human body.
• the invention relates to a device for anchoring a prosthetic heart valve to be put by a doctor and / or a surgeon.
• Heart valves are elastic, non-contractile structures whose main purpose is to allow one-way blood circulation in the body. In particular, they prevent blood from flowing back into the heart or arteries.
• Heart valves There are four valves in the heart: the tricuspid valve, the pulmonary valve, the mid-valve and the aortic valve.
• the valves are attached and surrounded by a valvular ring at the heart or vessels from the heart.
• the pathologies related to dysfunction of these valves are referred to as valvulopathies. The most common pathologies are:
• the valve can not open properly
• valvulopathies affect 2% of the adult population. This proportion seems to be constantly increasing, in particular because of the aging of the population. Indeed, some valvulopathies can be acquired as those related to the taking of drugs such as amphetamines. other Valvulopathies are due to a congenital anomaly. However, the vast majority of these pathologies are related to the age and degeneration of valves. The treatment of choice is the replacement of the valve, which requires a very heavy surgery imposing to implement an extracorporeal circulation on the patient. The surgeon must then sew a valve on the decalcified valve ring. In addition to the cost, the complications and the risks associated with such an operation, this option only applies to patients whose physical condition is good enough to recover from such an operation. However, 20% to 30% of the patients concerned are at high risk of surgery and rejected surgery.
• a prosthetic heart valve Another possibility is to introduce, via a catheter, a prosthetic heart valve.
• a prosthetic heart valve Such prostheses are described in particular in application EP 1977718 A.
• this type of valve is contained in a self-expanding prosthesis of circular section. Compacted in the catheter, it deploys automatically at the level of the valve ring.
• This type of prosthesis can therefore treat a larger number of patients, avoiding the disadvantages of surgery, and without having to suture the patient.
• these prostheses circular section
• the valvular ring especially in the mitral and tricuspid position, has an oval section.
• the circular section of the prostheses is therefore not perfectly adapted to the anatomical reality for certain rings. Slight leaks of blood can occur, which does not completely restore the patient's physical condition.
• Another disadvantage is that, under the pressure exerted by the blood, the prosthesis can be dislodged from the ring which encloses it which can cause the patient's mortality.
• CA 2752660 A1 which describes a device for anchoring a prosthetic valve at the level of the valve annulus of a patient, is particularly known. Also known is the application US 2007/0005129 A1 which describes a circular device for anchoring prosthetic valves, comprising hooks for fixing the valves in the aorta.
• these devices present also a circular section which does not solve the incompatibility problems between the circular section of the prosthesis and the oval section of the ring. In addition, they do not allow to adapt the diameter of the prosthesis to variations in the annular diameter. The phenomenon of escape therefore remains.
• These devices can not be used for mitral and tricuspid valves and there are significant leaks in the aortic position.
• the invention particularly aims to overcome these disadvantages of the prior art.
• an object of the invention is to provide, in at least one embodiment, a device for maintaining a prosthetic heart valve at the level of the valve ring.
• the invention also aims to design, in at least one embodiment, a device for adapting the apparent diameter of the prosthesis to the anatomical conditions of the patient.
• Another object of the invention is to provide, in at least one embodiment, a sufficiently resistant device to accomplish its mission throughout the life of a patient.
• the invention also aims to propose, in at least one embodiment, such a device whose design and manufacture are simple.
• such a device comprises:
• a compressible and expandable sealed toric element an anchoring element having a compressible and expandable mesh structure and a ventricular collar and an atrial collar connected by a tubular portion; said toric element surrounding said tubular portion of said anchor member and said anchor member enclosing said valvular heart prosthesis.
• the invention is based on a completely original approach of associating an anchoring element with another deformable element behaving as an adapter between the valve ring and a prosthetic valve of circular section.
• the shape of this deformable element is that of an open torus, able to accommodate a prosthetic valve in its hole.
• An open torus is defined by the revolution of a circle with a diameter called “minor diameter” around a straight line in its plane and not passing through its center.
• An open torus has a hole in its center.
• This toric element is expansive and compressive in a radial direction. It allows to adapt the diameter of the prosthesis to the anatomical configuration of each patient. Thus, the problems of leakage and displacement of the prosthetic valves, or even ejection out of the valve ring, are eliminated.
• the toric element makes it possible to show the deformations of the valvular ring related to the operation of the valve and / or the aging of the tissues. This characteristic also makes it possible to overcome the phenomenon of leakage due to the lack of adaptation of the diameters between the prosthetic valve and the valve ring.
• the anchoring element makes it possible to fix the prosthetic valve and the toric element more securely in the heart chamber. Thanks to its flanges that protrude from either side of the ring, the anchoring element is able to withstand the pressure exerted by the blood on the entire device and the prosthetic valve in particular. In addition, the collars maintain the toric element between them and prevent its movement in a longitudinal direction. Thus the toric element and the prosthetic valve can not move out of the ring.
• each flange has an outer diameter greater than or equal to the outer diameter of the toric element. This feature allows a particularly strong anchoring of the device and therefore a better maintenance of prosthetic valves on their implantation site.
• the device is slightly oversized with respect to the anatomical dimensions of the patient. This over-dimension of the elements of the device allows in particular to keep it in place by constant compression of the ring on the whole.
• the mesh structure allows the device surrounding the prosthesis to easily move from a retracted position, necessary for the installation of the prosthesis, to a functional deployed position. This mesh structure also allows compression of the prosthesis in order to introduce it into the catheter and allow its positioning without having recourse to surgery.
• said toric element also has a mesh structure covered with a film of polymer material.
• This overlap can be achieved either on the inner face of the toric element or on the outer face of the mesh. Covering with a film of polymer material prevents the passage of blood through the mesh of the toric element, between the annular wall and the outer wall of the cardiac prosthesis. More precisely, when the toric element is covered on its internal face, the mesh is left visible. When the O-ring element is covered on its outer face, the mesh is concealed by the film of polymer material.
• said polymeric material is selected from silicone, polytetrafluoroethylene (PTFE), polyurethane, polyamide, polyester, fluoric resin or by a combination of at least two of these materials. These materials have the advantage of being well tolerated by the body of the patient and being particularly tight. This cover with a waterproof polymer material helps eliminate the problem of leakage between the valve ring and the prosthetic valve. The device according to the invention therefore considerably improves the performance of current prosthetic valves.
• PTFE polytetrafluoroethylene
• polyurethane polyamide
• polyester polyester
• fluoric resin fluoric resin
• the anchoring device is never covered by any polymer material.
• the material constituting the device being left bare, the heart tissue is invaginated through the mesh constituting the anchoring element, which constitutes anfractuosities allowing the device to withstand cardiac contractions and blood pressure.
• This physiological and normal phenomenon of colonization of the device by the cardiac tissue makes it possible in particular to anchor the device more securely in the heart.
• said mesh structure is in at least one metal material having a shape memory or a shape memory polymer material.
• said shape memory metal material is chosen from nickel, titanium, cobalt, and the like, and the combination of at least two of these metals.
• said shape memory metal material is an alloy of nickel and titanium.
• said tubular portion of said anchoring element has a height h less than the minor diameter d of said toric element. These dimensions correspond to the device when it is deployed, is not subjected to any mechanical stress, and especially when it is not in place in the heart of a patient.
• the height h is defined as the height separating the two flanges of the anchoring element.
• This particular feature allows the anchor element to clipper the toric element between its flanges.
• the different elements constituting the device according to the invention are firmly held relative to each other.
• the absence of play between these elements contributes on the one hand to maintain the prosthesis in the device, and on the other hand to keep the entire device in the valve ring.
• said ring element has, on at least a portion of its outer periphery, an area of lower resistance to radial compression in situ.
• Ring compression in situ is that observed when the device is implanted in the heart of a patient.
• the zone of least resistance is in the middle zone of the toric element.
• This median zone can be defined as an evenly distributed zone on either side of the median plane defined by the major circle constituting the toric element.
• This zone of least resistance aims to prevent the deformation of the toric element, under the constraint of the valve ring in operation, is anarchic. It is indeed preferable that the deformation of the toric element is in a radial direction relative to the axis longitudinal of the prosthetic valve to be implanted, and not along an axis parallel to this longitudinal axis.
• this feature allows the device according to the invention to better adapt to the anatomy of each patient, as well as the deformations of the ring during its operation and / or over time. This allows the device not to be ejected out of the ring during its operation. This also provides an additional degree of flexibility not to hinder the proper functioning of the prosthetic valve by unnecessarily stiffening the valve ring.
• this area of least resistance extends, in implantation situation, approximately 5 mm on either side of the median plane of the toric element. This zone must allow the toric element radial deformation less than or equal to 5 mm in implantation situation.
• said area of least radial compressive strength in a situation comprises a discontinuity of the mesh constituting said mesh structure of said ring element and / or the use of variable elasticity materials such as a nickel and titanium alloy.
• said ring element has, on at least a portion of the surface defining its hole, a zone of resistance increased to the radial compression in situation.
• said resistance zone is in the central zone of said toric element. The presence of this zone is intended to avoid transmitting to the prosthetic valve the forces and mechanical stresses experienced by the anchoring device, and in particular by the toric element. Thus, the operation of the prosthetic valve is not impaired. This feature also helps to maintain the valve within the device, at the level of the valve ring. The limitation of the radial forces exerted on the wall of the prosthesis prevents it from moving gradually and being ejected out of the ring.
• said zone of resistance to radial compression extends, in implantation situation, about 5 mm on either side of the median plane of the toric element, at its internal diameter.
• said zone of resistance increased with radial compression in a situation comprises a mesh that is tighter than the rest of the mesh constituting said mesh structure of said toric element.
• said zone of resistance increased in situ radial compression comprises a reinforcing strip.
• a strip of polymer material located at the internal diameter of the toric element, that is to say surrounding the hole of the torus into which the prosthetic valve is inserted, makes it possible to grip and limit the radial compression. of the prosthesis.
• said atrial collar and said ventricular collar of said anchor element are symmetrical.
• said atrial collar and said ventricular collar of said anchoring element are asymmetrical.
• the ventricular collar may, for example, be prolonged in order to be able to be plated at the level of the walls of the ventricle during implantation.
• the contact area being larger, the anchoring of the device is more solid.
• the collar should be shaped not to obstruct a possible orifice of a vein or artery opening or leaving the heart.
• said ring member has an outer diameter D2 of between 30 mm and 70 mm.
• the toric element can be designed in different dimensions. It is in particular possible to design devices whose O-ring element may have an external diameter D2 equal to 30 mm, 40 mm, 50 mm, 60 mm or 70 mm.
• each of said flanges of said anchoring element has an outer diameter D4 of between 40 mm and 70 mm.
• each of the flanges may have an external diameter D4 of 40 mm, 50 mm, 60 mm or 70 mm. These dimensions will also be chosen according to the anatomical destination of the cardiac prosthesis to be implanted, and the size and weight of the patient.
• the outer diameter D4 of each of the flanges, atrial and ventricular is greater than or equal to the outer diameter D2 of the toric element and preferably.
• the device according to the invention further comprises stabilizing hooks. The presence of these hooks in particular allows to hang more firmly the device in the valve ring and cardiac tissue more generally. These hooks are particularly useful when the device and the prosthesis have just been placed. Indeed, colonization of the anchoring device by the heart tissue is not instantaneous. The hooks then allow to anchor more securely the device according to the invention the time that the fabric develops around the anchoring device.
• At least some of said hooks are distributed at the outer diameter D2 of said toric element.
• the presence of hooks at the circumference of the toric element makes it possible to anchor it in the valvular ring.
• At least some of said stabilizing hooks are provided on at least one of said atrial or ventricular flanges. The presence of these hooks allows in particular to fix the device in the heart tissue.
• said hooks are distributed uniformly.
• a uniform distribution at the circumference of the toric element or on at least one of said collars of the anchoring element makes it possible to distribute the forces of tension which are exerted on the cardiac tissue on the one hand, and the elements of the device on the other hand.
• the hooks may be distributed at an angle of between 5 degrees and 30 degrees, preferably at an angle of 15 degrees, to the outer circumference of the ring element and / or to the outer diameter of the at least one of said atrial or ventricular flanges.
• stabilizing hooks when stabilizing hooks are provided on the toric element, said stabilizing hooks are uniformly distributed both at the median plane of said toric element but also on either side of said median plane. .
• said stabilizing hooks have a length of between 1 mm and 3 mm, and a thickness of between 0.1 mm and 1 mm.
• said stabilizing hooks have a length of 3 mm and a thickness of 1 mm. 5.
• Figure 1 shows a schematic top view of the toric element of a first embodiment in its expanded state
• Figure 2 illustrates a side view of the O-ring in its deployed state
• - Figure 3 shows a side view of the anchoring element according to the invention, in its expanded state
• FIG. 4 illustrates a side view of the assembled device according to this first embodiment, in its deployed state
• Figure 5 shows a side view of the device of the assembled device according to this first embodiment and housing a prosthetic valve
• Figure 6 shows a schematic side view of a second embodiment of the device according to the invention.
• the general principle of the invention is based on the design of a device for anchoring a prosthetic valve within a valve ring, said device further behaving as an adapter between the circular section of such a prosthesis with the globally oval section of the valvular ring of a patient.
• a device therefore comprises a toric element, in the form of an open torus.
• the prosthetic valve is housed in the hole of this element.
• the toric element is compressible and expandable in a radial direction. This feature allows the element to deform to fit the patient's anatomy. It also adapts when the valve ring deforms, either during its operation or over time.
• This toric element cooperates with an anchoring element which makes it possible to root the device in the cardiac tissue.
• prostheses according to the invention are manufactured according to any method well known to those skilled in the art.
• the method of manufacturing such prostheses is not the subject of the present application.
• these prostheses may be manufactured from a wire of shape memory metal material to form two tubular mesh elements.
• the wire of shape memory metal material is twisted manually on a model to form a tubular element with a grid structure.
• the cutting of the tubular element to the appropriate dimensions can be done manually or by laser to obtain a clean cut of the ends of the wire.
• One of these tubular elements will then be shaped to form the anchoring element and the other of these tubular elements will then be shaped to form the toric element.
• the conformation can be done by applying a high temperature, locally, and by exerting a mechanical stress on the tubular element to be able to modify its curvature.
• the temperature to be applied must be sufficiently high to cause the deformation of the material without inducing the melting of the wire of metallic material. This temperature depends on the nature of the material, the qualitative and quantitative composition of the metal alloy ...
• FIGS. 1 to 5 an embodiment of the invention is presented.
• the components of the device are shown in Figures 1 to 5 in their expanded state and free of any mechanical stress.
• Figure 1 shows a top view of the toric element 2.
• This element is in the form of an open torus, that is to say a torus provided with a central hole.
• a torus is generated by the rotation of a minor circle around a line. The diameter of this circle is called minor diameter.
• the ring element shown in FIG. 1 has an internal diameter D1, which corresponds to the diameter of the hole of the core 21, and an external diameter D2.
• This diameter D2 may be between 40 mm and 70 mm, depending on the anatomical destination and the patient to be treated.
• the height of the torus is equal to the minor diameter d of the minor circle.
• the internal diameter D1 is compressive.
• the diameters D1 and D2 are shown in FIG. 1 slightly offset for greater readability.
• the toric element may be entirely covered with a waterproof polymer material 22, such as polytetrafluoroethylene (PTFE).
• PTFE polytetrafluoroethylene
• the element 2 also comprises a reinforcing strip 23, this band also also consisting of PTFE.
• the reinforcement strip 23 surrounds the hole 21 and makes it possible to limit the radial deformation at the level of the median zone. This reinforcement band makes it possible to prevent the diameter D1 from exceeding 30 mm in its median zone when the device is implanted.
• the element 2 is provided with stabilization hooks 5 for anchoring the element 2 in the heart tissue, and more precisely in the valve ring of the heart of a patient.
• These hooks 5 are placed on the outer circumference of the toric element 2. They have a length equal to 3 mm, a thickness of less than 1 mm and are made of the same material as the device 1.
• the distribution of the hooks is uniform and is made at an angle alpha a between 5 degrees and 10 degrees, preferably at an angle of 15 degrees.
• the hooks may also be uniformly distributed on either side of the median plane P of the torus as shown in Figure 2 (shown in dashed line).
• one third of the totality of the hooks is below the median plane P, about 3 mm from the plane, one third is at the median plane P and the third of the remaining brackets is below the plane.
• median P about 3 mm also.
• the hooks above and below the median plane P are equidistant from the plane line. The fact that the hooks are uniformly distributed over the entire circumference and on either side of the median plane P makes it possible to anchor the toric element 2 more securely to the patient's valvular ring.
• the ring element 2 has at its outer diameter D2 a zone 24 of lesser resistance to radial compression.
• this zone can be obtained by a discontinuity of the mesh or by the use of a variable modulus of elasticity material such as a nickel or titanium alloy.
• This discontinuity can be obtained during the production of the toric element by forming a tubular element meshed so that its ends are turned outwardly towards each other.
• This zone of least resistance allows the element 2 to deform preferentially at its outer diameter D2 which contributes in a first step to insert more easily the device 1.
• This zone also allows the toric element 2 of adapt more easily to the anatomy of the valve ring.
• the ring deforms during the opening or closing of the valve
• the presence of the zone 24 allows the element to deform in a radial direction and not longitudinal relative to the axis of the prosthesis .
• This feature contributes to the maintenance of the element at the level of the ring. Indeed, if the deformation of the element 2 was anarchic, it could be more easily moved out of the ring.
• the radial compression should be facilitated for a variation of about 5 mm. Compression must be more difficult beyond this value. Otherwise, the toric element would be too deformable and not properly fulfill its function as an adapter between the valve ring and the prosthetic valve.
• Figure 3 shows a cross section of the anchoring element 3.
• This element has two flanges 31 and 33 separated by a tubular portion 32 of height h.
• the atrial 31 and ventricular flanges 33 are symmetrical. They have a diameter D4 which can be between 40 mm and 70 mm.
• the tubular portion 32 has a diameter D3, which is measured at the median plane P of the anchoring element 3 and which is equal to 10 mm.
• the anchoring element is preferably not covered by any polymer material.
• the light 34 of this portion 32 can accommodate a prosthetic valve.
• the anchoring element 3 is inserted into the opening 21 of the torus so that the toric element encloses the tubular portion 32.
• the height h of the anchoring element 3 is slightly smaller than the diameter d of the minor circle of the toric element 2. This characteristic results in a slight crushing of the toric element 2 between the flanges 31 and 33. This makes it possible to avoid that there is too much clearance between this element 2 and the element of FIG. anchorage 3. These elements therefore cooperate closely.
• the prosthetic valve 4 is better maintained by the device according to the invention.
• the atrial 31 and ventricular flanges 33 have stabilization hooks 5 at their surface in contact with the cardiac walls.
• hooks are identical to those described above: their length is 3 mm, their thickness is about 0.1 to 1 mm and their distribution is uniform to the surface of the flanges at an angle of about 15 degrees.
• the hooks are oriented toward the tubular portion 32 and form an angle of about 90 degrees with the surface of the collars.
• Figure 4 is a photograph of the device 1 assembled, seen from the side.
• Figure 5 is a side view of the device assembled and housing a prosthetic valve.
• the device 1 comprises an anchoring element 3 and a toric element 2.
• the ring element identical to that described in FIG. 1 and 2, has the shape of an open torus, and thus comprises a hole 21. Its diameter external D2 is about 50 mm and its internal diameter Dl is equal to 10 mm. The diameter of its minor circle is 21.5 mm.
• the toric element 2 is covered with a waterproof polytetrafluoroethylene (PTFE) polymer film 22. This film is not shown in Figure 4, to reveal the structure of the element 2.
• the element 2 is provided at its inner diameter Dl of a reinforcement strip 23 of PTFE. This tape, which measures 10 mm, extends at the median plane P and on the inner face of the toric element 2.
• this reinforcing strip 23 extends over 5 mm on either side of the median plane P.
• the plane median P is shown in dashed lines in FIGS. 4 and 5.
• the toric element also comprises a zone of weakness 24 at its outer diameter D2, constituted by a discontinuity of the mesh, as represented in FIG. 4.
• the anchoring element 3 has two atrial 31 and ventricular flanges 33 separated by a tubular portion 32.
• Its outer diameter D4 is about 70 mm, and the internal diameter D3 is equal to that of D1, or 10 mm.
• the height h of the tubular portion 32 is 20.5 mm, and is therefore slightly less than that of the toric element 2.
• the ratio D4 / D2 is here of 1, 4.
• the tubular portion 32 fits into the hole 21 of the toroidal element so that the element 2 sheaths the tubular portion 32.
• This combination of features allows the elements 2 and 3 to cooperate in a close manner, which makes it possible to maintain the valve firmly in the heart of the device, to avoid involuntary movements of the elements relative to each other and to coordinate the deformations of the device according to that of the ring and the opening of the valve.
• the prosthetic valve is in the form of a tube with a diameter of about 40 mm in its expanded and unconstrained state. Its radial expansion is limited by the compression of the device 1 so that it is firmly held inside the device 1.
• the toric element 2, the anchoring element 3 and the prosthetic valve 4 are expansive and compressive in a radial direction.
• This feature allows the assembly to be compressed for insertion into the catheter which will place the assembly in the heart without having to open the patient's ribcage.
• This feature also allows device 1 and prosthesis 4 to cover their shape after the catheter has been removed.
• the elements 2, 3 and 4 have a mesh structure.
• This structure is visible in Figure 4 but is not shown in Figure 5 for reasons of clarity.
• the mesh structure can be made of a shape memory metal material, preferably in a nickel-titanium alloy. This type of material, and in particular the alloy of nickel and titanium, has the particularity of being easily compressible cold, which facilitates their insertion into the catheter. They are also able to recover their shape instantly at a higher temperature, including body temperature.
• the ventricular and atrial flanges 31 and 31 are provided with stabilizing hooks 5 at their surface in contact with the cardiac tissue. These hooks are identical to those described in Figure 2.
• the toric element 2 is also provided with hooks 5 at the central zone 24 of its outer circumference. As described above, the hooks 5 are distributed at an angle ⁇ of 30 degrees over the entire circumference of the element 2, at the median plane P but also on either side of this plane P, as explained above. In addition, they form an open angle of about 30 degrees with the wall of the O-ring element 2. The presence of these hooks makes it possible in particular to more securely fix the device and the prosthetic valve at the level of the valvular ring. and in the patient's heart chamber.
• FIG. 6 shows a side view of a second embodiment according to the invention.
• the device 100 according to the invention comprises a toric element 200 identical to that described in points 6.2 and 6.4.
• This toric element 200 is also covered with a sealed polymer film 202. It also has a zone of weakness 204 and a reinforcing band 203 made of PTFE, situated on the median plane P of the toric element 200 (shown in dashed line).
• This reinforcing strip is identical to the reinforcing strip 23 of the first embodiment.
• the anchoring element 300 differs from that described in points 6.3 and 6.4.
• This anchoring element 300 comprises two atrial flanges 301 and ventricular 303 separated by a tubular portion 302.
• the flanges are asymmetrical, shaped and dimension on either side of the median plane P.
• the flange The ear 301 has a generally circular shape with an outer diameter D4 which can be between 50 and 70 mm.
• the tubular portion has a diameter D3 of about 10 mm.
• the ventricular collar is asymmetrical in shape. It includes a longer portion 304 and a shorter portion 305.
• the portion 304 is intended to extend along the ventricular inner wall while the shorter portion 305 extends into the portion below the ring.
• This shape asymmetry makes it possible to anchor the device according to the invention more securely in the heart, since the surface in contact with the fabric is larger.
• the shorter portion 305 makes it possible not to close the aortic orifice, for example, when the device according to the invention is intended to anchor a prosthetic valve replacing the mitral valve.
• the elements 200 and 300 also comprise stabilizing hooks 500. These hooks 500 are distributed over the toric element and the ear flange as explained above. Briefly, the hooks 500 are distributed over the outer circumference of the toric element 200. Their distribution is at the same time at the median plane P of the element 200, but also on either side of this median plane P at an angle of 30 degrees. Hooks are also provided on the ear flange at an alpha angle of 30 degrees. They are oriented towards the tubular portion 302 of the element 300 and form with the surface of the collar an angle of 30 degrees.
• stabilizing hooks 500 are also provided at the ventricular flange 303. These hooks 500 are uniformly distributed at an angle of 30 degrees, and form with the surface of the collar an angle of 30 degrees. In another variant, it is also possible to provide additional stabilizing hooks at the long portion 304, to strengthen the anchoring of the device 100 in the heart tissue.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Cardiology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Transplantation (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Vascular Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Dermatology (AREA)
• Medicinal Chemistry (AREA)
• Epidemiology (AREA)
• Inorganic Chemistry (AREA)
• Prostheses (AREA)

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• 2012
  • 2012-01-13 FR FR1250357A patent/FR2985659B1/fr not_active Expired - Fee Related
• 2013
  • 2013-01-10 EP EP13700662.3A patent/EP2802292A1/de not_active Withdrawn
  • 2013-01-10 WO PCT/EP2013/050412 patent/WO2013104721A1/fr active Application Filing
  • 2013-01-10 US US14/371,801 patent/US9414910B2/en not_active Expired - Fee Related
• 2014
  • 2014-07-13 IL IL233637A patent/IL233637A0/en unknown

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