valve prosthesis

• US 7,648,528 B2
• Filed: 09/07/2005
• Issued: 01/19/2010
• Est. Priority Date: 09/07/2004
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Laboratories Perouse
• Inventors: Styrc, Mikolaj Witold
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/661,940
• Publication Number:
  US 20080077234A1
• Time in Patent Office: 1,595 Days
• Field of Search: 623 21- 219
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A valve prosthesis includes a flexible plug and an annular bearing reinforcement which is embodied such that it is radially rigid and surgically implantable in the area of a heart valve. The valve prosthesis is provided with an interchangeable prosthetic valve, is independent of the bearing reinforcement, endoluminally placeable and includes a tubular support which is radially deformable between a folded setting position and an unfolded position for implanting into a bearing structure and the flexible plug connected to a tubular support. The bearing reinforcement forms an annular support devoid of any plug capable of univocally limiting a blood flow circulation.

Claims

1. A valve prosthesis comprising:

a radially-rigid annular carrier structure to be surgically implanted at a location of a heart valve, said carrier structure comprising an annular support without any shutter for restricting a flow of blood to only one direction; and

an interchangeable prosthetic valve independent of said carrier structure, said prosthetic valve being configured to be inserted through and positioned in said carrier structure by an endoluminal process, said prosthetic valve including;

a tubular support radially deformable relative to a main axis, said tubular support including a tubular lattice covered in a liquid-proof stretchable film configured to define a solid liquid-proof cylindrical wall, said tubular support being deformable between a folded position in which said tubular support is to be inserted into said carrier structure, and a deployed position in which said tubular support is positioned within said carrier structure such that an outer periphery of said tubular support bears against said carrier structure; and

a flexible shutter connected to said tubular support and deformable between an obstruction position in which said flexible shutter extends transversely with respect to said tubular support, and a release position in which said flexible shutter is contracted transversely with respect to said tubular support under action of the blood flowing through said tubular support;

wherein said tubular support and said flexible shutter of said prosthetic valve are held within said carrier structure in the deployed position of said tubular support so as to be jointly and independently removable from and relative to said carrier structure by an endoluminal process.

2. The valve prosthesis of claim 1, further comprising a rigid member extending generally along a generator line of said tubular support, said rigid member being connected to said tubular support at least two points spaced apart along a longitudinal axis of said tubular support.

3. The valve prosthesis of claim 2, wherein said rigid member has a projecting end for connection to a prop for holding said prosthetic valve in position.

4. The valve prosthesis of claim 1, wherein said tubular support has a cylindrical middle trunk and a frustoconical collar at each axial end of said middle trunk, each of said frustoconical collars being configured to flare from said middle trunk towards ends of said tubular support.

5. The valve prosthesis of claim 1, wherein said tubular support is resilient and is shaped to be urged resiliently from said folded position towards said deployed position.

6. The valve prosthesis of claim 1, wherein said tubular support has a trunk and converging legs extending from said trunk so as to form a tripod, said converging legs each having a distal end connected together at a connection point lying substantially on a center longitudinal axis of said tubular support.

7. The valve prosthesis of claim 1, wherein said flexible shutter includes three membranes deformable between a closed position in which the free edges of the membranes touch one another in pairs over at least half their length, and an open position in which the three membranes are spaced apart from one another to allow blood to pass therethrough.

8. The valve prosthesis of claim 1, wherein said carrier structure includes a rigid ring and a set of rigid pegs each extending from said ring parallel to a center axis of said ring.

9. The valve prosthesis of claim 1, wherein said carrier structure includes a surface textile sheet to allow said carrier structure to be sutured to a body.

10. A treatment kit comprising:

said valve prosthesis of claim 1; and

a catheter for positioning said prosthetic valve in said carrier structure.

11. The valve prosthesis of claim 1, wherein said tubular support is configured to be held within said carrier structure in said deployed position without sutures or fasteners by a force of said outer periphery of said tubular support bearing against said carrier structure.

12. The valve prosthesis of claim 1, wherein said prosthetic valve is entirely independent of said carrier structure.

13. A valve prosthesis comprising:

a radially-rigid annular carrier structure to be surgically implanted at a location of a heart valve, said carrier structure comprising an annular support without any shutter for restricting a flow of blood to only one direction; and

an interchangeable prosthetic valve independent of said carrier structure to be inserted through and positioned in said carrier structure by an endoluminal process, said prosthetic valve including;

a tubular support radially deformable relative to a main axis, said tubular support including a tubular lattice covered in a liquid-proof stretchable film configured to define a solid liquid-proof cylindrical wall, said tubular support having a cylindrical middle trunk and a frustoconical collar at each axial end of said middle trunk, each of said frustoconical collars being configured to flare from said middle trunk towards ends of said tubular support, said tubular support being deformable between a folded position in which said tubular support is inserted into said carrier structure, and a deployed position in which said tubular support is positioned within said carrier structure such that an outer periphery of said tubular support bears against said carrier structure; and

a flexible shutter connected to said tubular support and deformable between an obstruction position in which said flexible shutter extends transversely with respect to said tubular support, and a release position in which said flexible shutter is contracted transversely with respect to said tubular support under action of the blood flowing through said tubular support.

14. A valve prosthesis comprising:

a radially-rigid annular carrier structure to be surgically implanted at a location of a heart valve, said carrier structure comprising an annular support without any shutter for restricting a flow of blood to only one direction, said carrier structure including a rigid ring and a set of rigid pegs each extending from said ring parallel to a center axis of said ring; and

an interchangeable prosthetic valve independent of said carrier structure to be inserted through and positioned in said carrier structure by an endoluminal process, said prosthetic valve including;

a tubular support radially deformable relative to a main axis, said tubular support including a tubular lattice covered in a liquid-proof stretchable film configured to define a solid liquid-proof cylindrical wall, said tubular support being deformable between a folded position in which said tubular support is inserted into said carrier structure, and a deployed position in which said tubular support is positioned within said carrier structure such that an outer periphery of said tubular support bears against said carrier structure; and

a flexible shutter connected to said tubular support and deformable between an obstruction position in which said flexible shutter extends transversely with respect to said tubular support, and a release position in which said flexible shutter is contracted transversely with respect to said tubular support under action of the blood flowing through said tubular support.