WO2003003949A2 - Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel - Google Patents

Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel Download PDF

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Publication number
WO2003003949A2
WO2003003949A2 PCT/FR2002/002352 FR0202352W WO03003949A2 WO 2003003949 A2 WO2003003949 A2 WO 2003003949A2 FR 0202352 W FR0202352 W FR 0202352W WO 03003949 A2 WO03003949 A2 WO 03003949A2
Authority
WO
WIPO (PCT)
Prior art keywords
stent
valve
assembly
expansion
wall
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/FR2002/002352
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English (en)
French (fr)
Other versions
WO2003003949A3 (fr
Inventor
Jacques Seguin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to DE60233493T priority Critical patent/DE60233493D1/de
Priority to JP2003509965A priority patent/JP4364633B2/ja
Priority to US10/482,270 priority patent/US7252682B2/en
Priority to AU2002329324A priority patent/AU2002329324B2/en
Priority to EP02764940A priority patent/EP1401359B1/fr
Priority to AT02764940T priority patent/ATE440567T1/de
Priority to CA2450935A priority patent/CA2450935C/fr
Publication of WO2003003949A2 publication Critical patent/WO2003003949A2/fr
Anticipated expiration legal-status Critical
Publication of WO2003003949A3 publication Critical patent/WO2003003949A3/fr
Priority to US11/829,682 priority patent/US7780726B2/en
Priority to US12/578,818 priority patent/US8002826B2/en
Priority to US13/212,227 priority patent/US8628570B2/en
Priority to US14/138,229 priority patent/US9149357B2/en
Ceased legal-status Critical Current

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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
    • A61F2/2403—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 pivoting rigid closure members
    • 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
    • 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
    • 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
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • the present invention relates to an assembly allowing the installation of a prosthetic valve in a body conduit, in particular a heart valve and in particular an aortic valve.
  • the installation of the stent thus allows the mounting of the valve in the body conduit, eliminating the need for an approach from the outside and therefore for direct surgical intervention.
  • This technique has the essential drawbacks of inducing a risk of damage to the valve by the balloon used to achieve the expansion of the stent, and of limiting the expansion force which it is possible to impart to the stent.
  • This limitation has repercussions on the anchoring of the stent, making it possible to move said assembly.
  • This limitation also has repercussions on the sealing of the stent at the level of the valve ring, which is particularly affected when calcified zones give the valve ring an irregular shape and / or a certain rigidity.
  • Another disadvantage of the prior art is that it directly links the commissures of the valves to the stent. As a result, an expansion of the stent, and therefore of the valve, different from that provided may result in poor coaptation of the valves and therefore a faulty operation of the valve.
  • the stent must therefore be subject to a predetermined expansion which prevents, or makes difficult, the adaptation of this stent to anatomical variability.
  • the prior art also has the disadvantages, in the event of implantation of an aortic valve, of requiring a very exact positioning of the stent in the aorta so that the valve is placed opposite the native valve ring, and induce a risk of blockage of the orifices of the coronary arteries opening at the level of the coronary ostia.
  • the present invention aims to remedy these various drawbacks.
  • the set which it concerns comprises, in a manner known per se: - the prosthetic valve to be implanted;
  • a radially expandable frame known as a "stent”, comprising at least one zone intended to be expanded to allow this stent, in the expanded state, to bear against the wall of the bodily duct to be fitted, this support socket allowing immobilizing this stent relative to this wall;
  • valve - means for mounting the valve relative to the stent making it possible to connect the valve to the stent so that the placement of the stent allows the valve to be mounted in the body conduit, expansion means such as a balloon catheter being provided to cause expansion of the stent at the site of implantation.
  • the valve and the stent are shaped so that the valve is located, when the expansion of the stent is carried out, outside the area or areas of the stent subjected to said expansion means.
  • the invention thus consists in separating the valve and this or these zones to be expanded, so that the expansion of the stent can be carried out with an expansion force suitable for perfect anchoring of this stent in the wall of the body conduit to be fitted. , and without any risk of destruction or alteration of the valve.
  • the stent comprises a valve mounting zone, which is separate from the zone or zones of the stent to be expanded, and said mounting means connect the valve to this mounting zone.
  • said mounting means are shaped such that the valve is axially movable relative to the stent between a non-implantation position in which it is outside of the area or areas of the stent to be expanded, and an implantation position, which it can reach after expansion of the stent in the body conduit, in which it is immobilized axially relative to the stent.
  • the valve can then form a separate sub-assembly from the stent before the placement of this stent in the body conduit, and can be placed in the stent once it has been implanted.
  • the valve is connected to the stent before the placement of this stent in the body conduit to be treated, and is therefore introduced into this conduit with the stent; said mounting means then comprise displacement means for, once the stent has been expanded, move the valve between said non-implantation position and said implantation position.
  • Said mounting means can then comprise one or more of the following arrangements:
  • these attachment members can be oriented radially with respect to the valve, so that they can be inserted into said wall during the radial deployment of the valve, or can be oriented tangentially with respect to the valve, so that they can be inserted into said wall during a pivoting of the valve about its axis or during a longitudinal movement relative to the stent;
  • conduits arranged in, or fixed on, the peripheral wall of the valve and rods arranged on the stent, or vice versa, these rods being able to be engaged and being able to slide through these conduits during the passage of the valve from its position non-implantation in its implantation position, means such as hooks which can be provided for immobilizing these conduits with respect to these rods in said implantation position; wires can be connected to the ends of said rods and can pass through said conduits, to easily guide these rods in these conduits.
  • valve mounting means relative to the stent are shaped so as to allow, beyond an expansion threshold of the stent, a different expansion of the valve and of the stent, so that a variation in the degree of expansion of the stent does not affect the degree of expansion of the valve.
  • the valve is thus not directly connected to the stent, and is in particular not connected to the stent at the commissures of its valves; it may have, in the expanded position of the stent, a predetermined diameter of its own, independent of the diameter of the stent. After implantation, the valve has therefore a configuration allowing its proper functioning whatever the degree of expansion of the stent, and this expansion of the stent can be adapted to the anatomical variability encountered at the implantation site.
  • the stent and / or the valve may include one or more elements limiting the maximum diameter of expansion of the valve, in particular at the commissural points of this valve. These elements can be longitudinal wires that the stent includes or a reinforcing element that includes the valve.
  • the valve has a peripheral wall of a diameter which is not constant in the axial direction, in particular a frustoconical shape whose diameter is reduced in the distal direction, and the zone of the stent intended to receive this peripheral wall of the valve has a shape corresponding to that of this peripheral wall.
  • the stent advantageously has a median portion of smaller diameter than its end portions. It can in particular have a general shape in two inverted truncated cones or in diabolo.
  • the stent thus has a distance from the wall of the body duct, in particular by a conical or diabolo shape, allowing the passage of body fluid to the coronary at the level of the coronary ostia.
  • the valve has a shape corresponding to the area of the stent at which it is intended to be mounted. advantageously,
  • the valve has a peripheral wall
  • the stent has, in the extension, on the distal side, of the area of the stent intended to receive the valve, a folding portion; this folding portion is movable between an extended position, in which it is in the extension of said zone on the distal side, and a folded position, in which it is placed against the internal face of the peripheral wall of the valve and traps this wall peripheral between it and said area of the stent, and - holding means are provided to maintain this folding portion in this folded position.
  • the peripheral wall of the valve is thus pressed against the stent, which seals the valve relative to the stent.
  • said holding means consist of a wire made of a rigid material but having a degree of elastic flexibility, such as a metallic material, having a wavy shape and extending over the entire circumference of said folding portion.
  • the stent comprises a sheath made of an impermeable biocompatible material, covering it at least partially.
  • This sheath forms both a fixing base for the valve and a sealing means between the stent and the wall of the body conduit.
  • the sheath can advantageously have lateral openings which are suitable for facing the coronary ostia at the time of implantation and thus making it possible to avoid any area of stagnation or non-circulation of the blood.
  • this folding portion is constituted by an extension of said sheath, which forms a sleeve beyond said zone of the stent intended to receive the valve. A perfect seal is thus obtained between the valve and the stent.
  • the stent has, attached to said sheath, at least one inflatable peripheral chamber, which can be inflated so as to form a seal ensuring the seal between the stent and the wall of the body conduit to be fitted.
  • This seal is thus ensured notwithstanding the possible presence of calcified portions giving an irregular shape to a heart ring.
  • the stent has two inflatable peripheral chambers placed on either side of the portion of the stent intended to bear against a cardiac valve ring.
  • the stent may have a cylindrical portion, suitable for bearing against a cardiac valve ring, and a distal portion, connected to this cylindrical portion.
  • This distal portion forms at least in part said zone intended to receive the peripheral wall of the valve. It has the advantage that said wall of waterproof biocompatible material is located at this level. portion, away from the wall of the body conduit, which, in the case of implantation of an aortic valve, eliminates the risk of masking the coronary ostia.
  • the stent may also have a frustoconical or flared proximal portion, the diameter of which decreases in the distal direction, proper, in the case of the implantation of a heart valve, to bear against the wall of the ventricle or the corresponding atrium of the heart.
  • This proximal portion makes it possible to define the position of the stent, and therefore subsequently of the valve, relative to the implantation area. It also contributes to ensuring perfect immobilization of the stent.
  • the stent may also have an additional support portion connected by filiform rods to said distal portion or to said cylindrical portion, these filiform rods having lengths such that this additional support portion is placed beyond the coronary ostia.
  • the stent has hooks movable between a withdrawal position, which they occupy before expansion of the stent, and a deployment position, in which they are brought during the deployment of the stent and in which they are inserted in a wall defining the bodily duct.
  • the stent may also have a portion close to the valve ring, or facing or on this valve ring, having a high radial force, that is to say a radial force making it possible to erase local anatomical irregularities, as for example example of calcifications, and this in order to strengthen the tightness of the junction between the stent, the sheath and the wall of the treated duct.
  • This portion can be deployed using an expansion system with high radial force and not very compliant, for example a balloon.
  • Figure 1 is a side view of an expandable frame, called "stent” that it comprises;
  • Figure 2 is a longitudinal sectional view of a sheath which it comprises, according to a first embodiment;
  • Figure 3 is a longitudinal sectional view of a heart valve it comprises, according to this first embodiment;
  • Figure 4 is a view of a detail of the stent, on an enlarged scale;
  • Figure 5 is a view of another detail of the stent, on an enlarged scale, in a non-expanding state of the stent;
  • Figure 6 is a view of the same detail, in section along the line VI-VI of Figure 5;
  • Figure 7 is a view similar to Figure 5 in an expanded state of the stent;
  • Figure 9 is a longitudinal sectional view of the assembly according to the invention, after implantation in an aorta;
  • Figure 10 is a longitudinal sectional view of the sheath and the valve that comprises the assembly according to the invention, according to a second embodiment, with the catheter for bringing the valve in this sheath;
  • Figure 11 is a perspective view of the valve according to the second embodiment;
  • Figure 12 is a view similar to Figure 10, after installation of the valve;
  • Figure 13 is a view similar to Figure 9, of the assembly according to a third embodiment;
  • Figure 14 is a perspective view of the valve capable of being placed in the stent shown in Figure 13, and
  • Figures 15 to 17 are views of the assembly according to the third embodiment, in section along lines XV-XV, XVI-XVI and XVII-XVII respectively in Figure 13.
  • Figures 1 to 3 respectively represent an expandable frame 2, called “stent”, a sheath 3 and a prosthetic valve 4.
  • This stent 2, this sheath 3 and this valve 4 make up an assembly 1, visible in FIG. 9, allowing the placement of valve 4 in an aorta 100, showing the location of the coronary ostia 101 and the birth of the coronaries 104.
  • the stent 2 successively comprises, from one axial end to the other, in the proximal / distal direction, a tapered proximal portion 10, a proximal cylindrical portion 11, a distal tapered portion 12 , several connecting rods 13 and a distal cylindrical portion 14.
  • This stent 2 is made of metallic material, steel or a shape memory alloy.
  • This shape memory material may in particular be that known under the name "NITINOL”.
  • the portions 10 to 12 and 14 consist of a network of filaments forming juxtaposed meshes in the form of a diamond or, for the portion 10, in the form of a triangle.
  • the material constituting the stent 2 is such that these meshes can pass from a contracted configuration, in which the filaments are close to each other, giving the meshes an elongated shape, to an expanded configuration, visible in FIG. 1 and on the Figure 7 in detail, in which the filaments are spaced from each other.
  • the assembly 1 can be introduced into the aorta 100 by means of a catheter, up to the area at which the prosthetic valve 4 must be implanted; in the expanded configuration, the stent 2 bears against the aorta 100, the wall 102 of the ventricle and the native valve ring 103 in the manner shown in FIG. 9, so that it allows the implantation of the valve 4 in place of the native valve, the latter having been previously removed if necessary.
  • the portion 10 has a diameter which decreases in the distal direction, this portion 10 being shaped to, in the expanded state, bear against the wall 102 of the ventricle of the heart.
  • the portion 11 has, in the expanded state, a diameter such that it is able to bear against the native valve ring 103 and a radial force such that it can push back the native valve (or its residues after partial excision ) against the ring 103 so as to seal there.
  • This portion 11 has deployable hooks 15, visible more particularly in FIGS. 5 to 8. These hooks 15 allow the stent 2 to be anchored to the aorta 100 through the sheath 3.
  • each hook 15 extends in the longitudinal direction of a mesh, being pivotally connected to a proximal area 16 for connection of two proximal filaments 17.
  • This hook 15 has a free end 15a which is curved and tapered, and a face 15b turned towards the inside of the stent 2, of rounded shape.
  • the distal zone 18 of connection of the two other filaments 19 located on the side opposite to the base of the hook 15 is capable of coming to bear, during the expansion of the stent 2, on this face 15b, as can be deduced from the comparison of FIGS. 6 and 8.
  • the support of this zone 18 along this face 15b makes it possible to deploy the hook 15 radially towards the outside of the stent 2 and to maintain this hook 15 in the deployed position, in which its tapered end 15a is inserted into the wall of the ring 103.
  • the hooks can have a hook shape in order to prevent their removal.
  • the portion 12 is directly connected to the portion 11 and has a decreasing diameter in the distal direction.
  • This portion 12 is intended to extend at the level of the coronary ostia 101 and to receive the valve 4. Its frustoconical shape allows the sheath 3 to be kept away from the coronary ostia 101 and therefore to prevent any risk of covering the orifices 104 of the coronaries which lead into them.
  • the portion 12 further comprises a series of internal arms 25 visible more particularly in FIG. 4.
  • Each arm 25 is connected by its proximal end to a junction zone 16 of two proximal filaments 17 of a mesh, near the portion 11, and has a curved distal end 25a.
  • These arms 25 are inclined towards the inside of the portion 12 before the valve 4 is put into place on the stent 2, and FIG. 4 shows that, in this position, they can receive the valve 4.
  • This in fact comprises a peripheral wall 30 in which are arranged longitudinal tunnels 31 adapted to receive the arms 25; the latter can then be folded against the wall of the portion 12, either by deformation of the material constituting the arms 25 and / or the portion 12, or by shape memory when a shape memory material is used.
  • the connecting rods 13 connect the distal edge of the portion 12 to the proximal edge of the portion 14. They are regularly arranged on the periphery of the stent 2 and, as shown in FIG. 9, have a sufficient length so that the portion 14 is placed, after implantation, beyond the coronary ostia 101. The spacing of these rods 13 can be clamped by an annular element making it possible to limit the upper diameter of the valve 4 to a predefined size.
  • the portion 14 has for its part, in the expanded state, a diameter slightly greater than the internal diameter of the aorta 100, and bears against the wall of the latter once the stent 2 is put in place.
  • This portion 14 can be fitted with hooks 15.
  • the sheath 3 is made of a waterproof biocompatible material, such as pericardial tissue, of material known under the name "DACRON" or a polymer, such as polyurethane, and has portions 35, 36 and 37. These portions 35, 36 and 37 are adapted to be connected respectively to the portions 10, 11 and 12, and to closely match these portions 10 to 12, in the expanded state thereof.
  • the connection between the sheath 3 and the portions 10 to 12 is carried out, at the time of assembly of the assembly 1, by seams.
  • the connection can also be made by molding a polymeric material.
  • the sheath 3 On the proximal side, the sheath 3 has a flap 40 extending on the outer face of the portion 35.
  • This flap 40 comprises, near its free edge, an inflatable peripheral chamber 41.
  • This chamber 41 can be inflated so as to form a seal ensuring a seal between the sheath 3 and the wall of the ventricle 102, on the proximal side of the native valve ring 103.
  • the sheath 3 On the distal side, the sheath 3 has a flap 42 extending on the outer face of the portion 12.
  • This flap 42 comprises, near its free edge, an inflatable peripheral chamber 43, similar to the chamber 41 and capable of being inflated in the same way as the latter.
  • This chamber 43 provides a seal between the sheath 3 and the ring 103, on the distal side thereof.
  • This sleeve 45 includes a metal wire 46 extending over its entire circumference, this wire 46 having a wavy shape and being elastically deformable. The deformability of this wire 46 allows the sleeve 45 to pass from its extended position shown in FIG. 2 to its folded position shown in FIG. 9, in which it is held by elastic return of the wire 46. In this folded position, the sleeve 45 is placed against the internal face of peripheral wall 30 of valve 4 and traps this wall 30 between itself and said portion 12.
  • the valve 4 can be made of a biological material or a synthetic material or a combination of these two types of material. Its peripheral wall 30 has a frustoconical shape adapted to its narrow fitting in the portion 12 when the arms 25 are folded against this portion 12, which ensures perfect immobilization of the valve 4 in the stent 2.
  • the assembly of the assembly 1 is carried out by placing the sheath 3 on the stent 2 and the valve 4 on the arms 25, the stent 2 being in the contracted state.
  • the assembly 1 is then placed in a catheter allowing its introduction into the patient's body, this catheter including one or more inflatable balloons capable of deploying the portions 10, 11 and 14.
  • this catheter is brought into position in the aorta
  • the balloons are then inflated to deploy the portions 10, 11 and 14; the forced deployment of the portion 11, which they carry out, makes it possible to ensure the deployment of the hooks 15 and to cause the deployment of the portion 12, therefore of the valve 4.
  • the chambers 41, 43 are then inflated to ensure the sealing of the sheath 3 with respect to the ring 103, and the sleeve 45 is folded back inside the portion 12 to clamp the peripheral wall 30 of the valve 4 against this portion 12.
  • the valve 4 and the stent 2 are shaped so that the valve 4 is located outside of the zone or zones 10, 11, 14 to be expanded.
  • the expansion of the stent 2 can be carried out with an expansion force suitable for perfect anchoring of this stent 2 in the receiving walls 100, 102, 103, and without any risk for the valve 4.
  • the hooks 15 make it possible to ensure perfect immobilization of the assembly 1 in the aorta 100, and the chambers 41, 43, as well as the sleeve 45, make it possible to ensure perfect sealing of the assembly 1 relative to the 'aorta 100.
  • the valve 4 is not pre-mounted inside the stent 2 but is put in place once the expansion of the stent 2 has been carried out.
  • the sheath 3 then has internal tubes 50 arranged to protrude inside the stent 2 once this sheath 3 engaged on the stent 2. These tubes 50 can in particular be sewn or fixed by any other means to the sheath 3 after positioning of the latter on the stent 2.
  • each clip 51 has an internal arm 52 engaged longitudinally in the wall 30, and an external straight arm 53, extending along the external face of the wall 30.
  • the arms 53 terminate in curved ends and are connected to wires 55 engaged and able to slide in the tubes 50.
  • a catheter 80 is used to bring the valve 4 into position in the sheath 3.
  • the valve 4 is slidably engaged on the catheter 80, and the wires 55 are, after having passed through the tubes 50, engaged into the catheter 80 from the distal opening thereof and pass through this catheter 80 in order to be actuated from the outside.
  • the establishment and deployment of the valve 4 is achieved by pulling on the different wires 55 so as to engage the different arms 53 in the respective tubes 50.
  • the internal arms 52 can comprise (cf. FIG. 12) proximal hooks which make it possible to complete the deployment of the valve 4 by being hooked to the wall of the sheath 3, for example by means of the inflation of a balloon.
  • the stent 2 forms a central cage delimited by a ring 60 and by longitudinal wires 61, in which the valve 4 is inserted tightly.
  • a side wall 30 of tubular shape in which three lateral openings 65 are arranged. These openings 65 are positioned facing the coronary ostia 101 and allow a natural flow of blood, without risk of stagnation at the level of these coronary ostia 101.
  • the invention provides an assembly 1 for placing a valve 4 in a body conduit 100 having, compared with homologous assemblies of the prior art, the following advantages:

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial 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)
  • Prostheses (AREA)
PCT/FR2002/002352 2001-07-04 2002-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel Ceased WO2003003949A2 (fr)

Priority Applications (11)

Application Number Priority Date Filing Date Title
DE60233493T DE60233493D1 (de) 2001-07-04 2002-07-04 Anordnung zum einsetzen einer ventilprothese in ein körpergefäss
JP2003509965A JP4364633B2 (ja) 2001-07-04 2002-07-04 体内の管腔の中に人工弁を配置するためのアッセンブリー
US10/482,270 US7252682B2 (en) 2001-07-04 2002-07-04 Kit enabling a prosthetic valve to be placed in a body enabling a prosthetic valve to be put into place in a duct in the body
AU2002329324A AU2002329324B2 (en) 2001-07-04 2002-07-04 Kit enabling a prosthetic valve to be placed in a body enabling a prosthetic valve to be put into place in a duct in the body
EP02764940A EP1401359B1 (fr) 2001-07-04 2002-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel
AT02764940T ATE440567T1 (de) 2001-07-04 2002-07-04 Anordnung zum einsetzen einer ventilprothese in ein kírpergefäss
CA2450935A CA2450935C (fr) 2001-07-04 2002-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel
US11/829,682 US7780726B2 (en) 2001-07-04 2007-07-27 Assembly for placing a prosthetic valve in a duct in the body
US12/578,818 US8002826B2 (en) 2001-07-04 2009-10-14 Assembly for placing a prosthetic valve in a duct in the body
US13/212,227 US8628570B2 (en) 2001-07-04 2011-08-18 Assembly for placing a prosthetic valve in a duct in the body
US14/138,229 US9149357B2 (en) 2001-07-04 2013-12-23 Heart valve assemblies

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0108898A FR2826863B1 (fr) 2001-07-04 2001-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel
FR0108898 2001-07-04

Related Child Applications (3)

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US10482270 A-371-Of-International 2002-07-04
US10/482,270 A-371-Of-International US7252682B2 (en) 2001-07-04 2002-07-04 Kit enabling a prosthetic valve to be placed in a body enabling a prosthetic valve to be put into place in a duct in the body
US11/829,682 Continuation US7780726B2 (en) 2001-07-04 2007-07-27 Assembly for placing a prosthetic valve in a duct in the body

Publications (2)

Publication Number Publication Date
WO2003003949A2 true WO2003003949A2 (fr) 2003-01-16
WO2003003949A3 WO2003003949A3 (fr) 2004-01-22

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PCT/FR2002/002352 Ceased WO2003003949A2 (fr) 2001-07-04 2002-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel

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US (5) US7252682B2 (enExample)
EP (1) EP1401359B1 (enExample)
JP (1) JP4364633B2 (enExample)
AT (1) ATE440567T1 (enExample)
AU (1) AU2002329324B2 (enExample)
CA (1) CA2450935C (enExample)
DE (1) DE60233493D1 (enExample)
ES (1) ES2335651T3 (enExample)
FR (1) FR2826863B1 (enExample)
WO (1) WO2003003949A2 (enExample)

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DE60233493D1 (de) 2009-10-08
FR2826863A1 (fr) 2003-01-10
CA2450935A1 (fr) 2003-01-16
JP2005505320A (ja) 2005-02-24
AU2002329324B2 (en) 2007-07-12
FR2826863B1 (fr) 2003-09-26
WO2003003949A3 (fr) 2004-01-22
ATE440567T1 (de) 2009-09-15
US8002826B2 (en) 2011-08-23
US7252682B2 (en) 2007-08-07
US20100036485A1 (en) 2010-02-11
US20140188220A1 (en) 2014-07-03
US7780726B2 (en) 2010-08-24
ES2335651T3 (es) 2010-03-31
EP1401359A2 (fr) 2004-03-31
US20080215143A1 (en) 2008-09-04
US20110301692A1 (en) 2011-12-08
US8628570B2 (en) 2014-01-14
US9149357B2 (en) 2015-10-06
EP1401359B1 (fr) 2009-08-26
JP4364633B2 (ja) 2009-11-18
US20050043790A1 (en) 2005-02-24
CA2450935C (fr) 2010-09-21

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