Tubular Supporting Prosthesis Having a Heart Valve, Particularly for Aortic Valve Replacement

• US 20100280597A1
• Filed: 02/15/2008
• Published: 11/04/2010
• Est. Priority Date: 02/16/2007
• Status: Active Grant

• Current Assignee: Universität Zürich
• Original Assignee: Universität Zürich
• Inventors: Hoerstrup, Simon-Philipp, Fliedner, Thilo, Zund, Gregor, Baaijens, Frank
• Granted Patent: US 8,617,237 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth

Abstract

The invention relates to a tubular supporting prosthesis, comprising two terminal regions relative to the longitudinal supporting prosthesis axis and a center region disposed between the two terminal regions, wherein every terminal region is provided with a mesh structure made of at least two structural rings, which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal supporting prosthesis axis. The center region is formed by elongated connecting members, which are connected to the structural rings respectively disposed adjacent to the center of the longitudinal supporting prosthesis axis. An aortic valve, which is produced by means of tissue engineering, is fastened and/or integrated in the center region.

Claims

1. A tubular supporting prosthesis comprising

two terminal regions relative to the longitudinal axis of the supporting prosthesis and a middle region disposed between the two terminal regions,

wherein each of said terminal regions comprises a mesh structure made of at least two structural rings which are connected to one another via connecting members and are disposed point symmetrically about the longitudinal axis of the supporting prosthesis,

wherein the region is formed by elongated connecting members which are connected with each of the structural rings disposed closest to the middle point of the longitudinal axis of the supporting prosthesis, and

wherein an aortic valve produced by means of tissue engineering is fixed and/or integrated into the middle region.

2. The supporting prosthesis according to claim 1, wherein at least one structural ring of the mesh region comprises n periodic deformations extending along the longitudinal axis of the supporting prosthesis and forming crests and troughs, said deformations comprising an amplitude A relative to the longitudinal axis of the supporting prosthesis,

wherein n=16-70, with a preferred range of n=20-56, and an especially preferred range of n=24-42.

3. The supporting prosthesis according to claim 2, wherein the deformations are sinusoidal, rectangular, saw-tooth or triangular shaped.

4. The supporting prosthesis according to claim 2, wherein the number of the periodic deformations of two respectively neighboring structural rings is identical or differs from one another by a multiple of a whole number.

5. The supporting prosthesis according to claim 2, wherein two neighboring structural rings are phase-shifted to one another such that crests of one structural ring are connected with troughs of a respectively neighboring structural ring via the connecting members.

6. The supporting prosthesis according to claim 1, wherein the connecting members are fashioned as rings, clamps, loops, threads, wires or struts, said loops, threads, wires or struts extending parallel to the longitudinal axis of the supporting prosthesis.

7. The supporting prosthesis according to claim 1, wherein the structural rings and/or the connecting members consist at least in part of a biologically degradable material.

8. The supporting prosthesis according to claim 7, wherein the biologically degradable material is chosen from at least one alloy, at least one polymer or at least one stainless steel with shape memory.

9. The supporting prosthesis according to claim 8, wherein the alloy with shape memory is a nickel-titanium alloy, an aluminium alloy, a magnesium alloy or an iron alloy.

10. The supporting prosthesis according to claim 7, wherein the biologically degradable polymer is polyglycolic acid (PGA), polylactic acid (PLA), polyhydroxyalkanoate (PHA), poly-4-hydroxybutyrate (P4HB), polycaprylactones (PLGA), polycarbonates, polyamides, polyanhydrides, polyamino acids, polyorthoesters, polyacetates, polycyanoacrylates as well as degradable polyurethanes and non-erodible polymers such as polyacrylates, ethylenvinylacetate polymers, other substituted cellulose acetates as well as derivatives thereof, polyesters of the hydroxycarboxy acids, polyanhydrides of the dicarboxyesters, copolymers of the hydroxycarboxy acids and of the dicarboxyesters, a synthetic polymer of at least one glycolide, lactide, p-dioxanone, caprylactone, trimethylenecarbonate and/or butyrolactone, polymers or copolymers of glycolic acid, lactic acid and sebacic acid, polyhydroxyalkanoate compositions of 2-, 3-, 4-or 5-hydroxy acids, e.g. poly-4-hydroxybutyrates, a poly-4-hydroxybutyrate-co-3-hydroxbutyrate, homopolymers and copolymers with any desirable combination of 3-hydroxybutyrates, 3-hydroxyvalerate, 3-hydroxyproprionate, 2-hydroxybutyrate, 4-hydroxybutyrate, 4-hydroxyvalerate, 3-hydroxyhexanoate, 3-hydroxyheptanoate, 3-hydroxyoctanoate, 3-hydroxynonanoate, 3-hydroxytridecanoate, 3-hydroxytetradecanoate, 3-hydroxypentadecanoate, 3-hydroxyhexadecanoate, 3-hydroxyheptadecanoate and 3-hydroxyoctadecanoate or a combination thereof.

11. The supporting prosthesis according to claim 1, wherein the structural ring and/or connecting members comprise at least one predetermined breaking point.

12. The supporting prosthesis according to claim 11, wherein the at least one predetermined breaking point is disposed on or next to the middle point between the crest and the trough of the periodically deformed structural ring.

13. The supporting prosthesis according to claim 11, wherein the at least one predetermined breaking point is made of one non-metallic material.

14. The supporting prosthesis according to claim 2, wherein the length of the elongated connecting members is 0.75-3-fold, preferably preferred 1-2 fold of the amplitude A.

15. The supporting prosthesis according to claim 12, wherein the at least one predetermined breaking point is fashioned such that it can be forced apart, dissolved or weakened by external influence.

16. The supporting prosthesis according to claim 15, wherein the external influence is chosen from:

sound waves;

at least one magnetic field;

a combination of magnetic field and electromagnetic field;

electromagnetic radiation;

electrical energy and any desired combination thereof.

17. The supporting prosthesis according to claim 16, wherein the sound waves are ultrasound and/or shock waves.

18. The supporting prosthesis according to claim 16, wherein the combination of magnetic and electromagnetic field is magnetic resonance imaging (MRI).

19. The supporting prosthesis according to claim 16, wherein the electromagnetic radiation is X-ray radiation or infrared radiation (thermal energy).

20. The supporting prosthesis according to claim 15, wherein the external influence is applied from inside or outside of the body.

21. The supporting prosthesis according to claim 20, wherein the influence from inside the body is applied with the help of an intravascular catheter or in a minimally invasive manner with the help of endoscopy.

22. The supporting prosthesis according to claim 8, wherein the biologically degradable polymer with shape memory is tert-butylacrylate, poly(ethyleneglycol)dimethacrylate or PCL combined with 2,4-toluenediisocyanate ethyleneglycol.