Tubular supporting prosthesis capable of growing

• US 8,636,793 B2
• Filed: 02/15/2008
• Issued: 01/28/2014
• Est. Priority Date: 02/16/2007
• Status: Active Grant

• Current Assignee: Universität Zürich
• Original Assignee: Universität Zürich
• Inventors: Zund, Gregor, Fliedner, Thilo, Baaijens, Frank, Hoerstrup, Simon-Philipp
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US12/527,132
• Publication Number:
  US 20110060401A1
• Time in Patent Office: 2,174 Days
• Field of Search: 623/1.2, 623/1.26
• US Class Current: 623/1.2
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C25F 3/22 of heavy metals

Abstract

The invention relates to a tubular supporting prosthesis capable of growing, comprising a mesh structure, wherein the mesh structure comprises 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, wherein the structural rings and/or the connecting members have at least one predetermined breaking point.

Claims

1. A tubular supporting prosthesis, comprising:

a mesh structure,

wherein the mesh structure comprises at least two structural rings which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal axis of the supporting prosthesis,

wherein the structural rings comprise at least one predetermined breaking point,

wherein said prosthesis is capable of growth, and

wherein the at least one predetermined breaking point comprises multiple layers of different biologically degradable materials, wherein the multiple layers of different biologically degradable materials are located only at the predetermined breaking point area, such that the rate of dissolution of the predetermined breaking point proceeds in a chronologically graduated manner.

2. The supporting prosthesis according to claim 1, wherein at least one structural ring of the mesh structure 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.

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

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 each other by a whole number.

5. The supporting prosthesis according to claim 2, wherein two neighboring structural rings are phase-shifted with respect 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 or 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 are made 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 material is a polymer selected from the following group:

polyglycolic acid (PGA), polylactic acid (PLA), polyhydroxyalkanoate (PHA), poly-4-hydroxybutyrate (P4HB), polycaprolactones (PLGA), polycarbonates, polyamides, polyanhydrides, polyamino acids, polyorthoesters, polyacetates, polycyanoacrylates as well as degradable polyurethanes and non-erodible polymers such as polyacrylates, ethylenevinylacetate 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, caprolactone, 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 desired combination of 3-hydroxybutyrates, 3-hydroxyvalerate, 3-hydroxyproprionate, 2-hydroxbutyrate, 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 2, wherein the at least one predetermined breaking point is disposed on or next to a middle line between neighboring crests and troughs of the periodic deformations of the structural ring.

12. The supporting prosthesis according to claim 1, comprising a mesh structure at each of two terminal ends of the supporting prosthesis relative to a longitudinal axis of the supporting prosthesis, wherein of the at least two structural rings, two structural rings disposed closest to a middle point of the longitudinal axis of the supporting prosthesis are connected with one another via elongated connecting members.

13. The supporting prosthesis according to claim 2,

wherein the mesh structure of two terminal ends of the supporting prosthesis relative to a longitudinal axis of the supporting prosthesis,

wherein of the at least two structural rings disposed closest to a middle point of the longitudinal axis of the supporting prosthesis are connected with one another via elongated connecting members,

wherein the length of the elongated connecting members is 0.75-3-fold of the amplitude A.

14. The supporting prosthesis according to claim 1, further comprising, on an inner side thereof, a heart valve or a vessel.

15. The supporting prosthesis according to claim 14, wherein the heart valve is sewed, glued, clamped or woven to the supporting prosthesis.

16. The supporting prosthesis according to claim 14, wherein the heart valve is the product of a tissue engineering method.

17. The supporting prosthesis according to claim 1, wherein the at least one predetermined breaking point is made of a non-metallic material.

18. The supporting prosthesis according to claim 1, wherein the at least one predetermined breaking point is formed such that it can be broken apart, dissolved or weakened by external influence.

19. The supporting prosthesis according to claim 18, 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.

20. The supporting prosthesis according to claim 19, wherein the sound waves are ultrasound and/or shock waves.

21. The supporting prosthesis according to claim 19, wherein the combination of magnetic field and electro-magnetic field is magnetic resonance imaging (MRI).

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

23. The supporting prosthesis according to claim 18, wherein external influence is applied from inside or outside of the body.

24. The supporting prosthesis according to claim 23, wherein the influence from within the body in applied with the help of an intravascular catheter or in a minimally invasive manner with the help of endoscopy.

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

26. The supporting prosthesis according to claim 1, wherein the connecting members comprise at least one predetermined breaking point.

27. The supporting prosthesis according to claim 2, wherein n=20-56.

28. The supporting prosthesis according to claim 2, wherein n=24-42.

29. The supporting prosthesis according to claim 13, wherein the length of the elongated connecting members is 1-2 fold of the amplitude A.

31. A tubular supporting prosthesis according to claim 1 or claim 30, wherein the prosthesis is coated with one or more biologically degradable materials, or one or more non-biologically degradable materials.

30. A tubular supporting prosthesis, comprising:

a mesh structure,

wherein the mesh structure comprises at least two structural rings which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal axis of the supporting prosthesis,

wherein the structural rings comprise at least one predetermined breaking point,

wherein said prosthesis is capable of growth, and

wherein the at least one predetermined breaking point comprises multiple layers of different biologically degradable materials, wherein at least one of the multiple layers of different biologically degradable materials, the multiple layers of different biologically degradable materials being located only at the predetermined breaking point, has a different rate of dissolution than one or more of the other multiple layers at the predetermined breaking point, such that the rate of dissolution of the predetermined breaking point proceeds in a chronologically graduated manner.