PERCUTANEOUSLY IMPLANTABLE FLAP STENT, DEVICE FOR APPLYING THE SAME AND METHOD FOR PRODUCING THE FLAP STENT

• US 20120101567A1
• Filed: 06/24/2010
• Published: 04/26/2012
• Est. Priority Date: 06/29/2009
• Status: Active Grant

• Current Assignee: BE Innovative GmbH
• Original Assignee: BE Innovative GmbH
• Inventors: Jansen, Josef
• Granted Patent: US 9,566,151 B2
• Time in Patent Office: Days
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

A valve stent includes a plurality of crown elements arranged coaxially one behind the other, each formed by several u-shaped bends with at least one base and two ends. The bases of one crown element are connected to the ends of another crown element via connection bars. To produce this valve stent, 3D droplet dosing technology is used to form a thin-walled sandwich structure. A device, suitable for application of a stent is provided with positioning wires having clamps at their ends which can be connected to the fixing hooks at the ends of the crown elements in force-locking manner.

Claims

1. A valve stent comprising:

a plurality of crown elements arranged coaxially one behind the other, each of said crown elements being formed by several u-shaped bends with at least one base and two ends and

connection bars, each of the connection bars connecting the base of one crown element to the ends of another crown element.

2. A valve stent, according to claim 1, wherein at least one of the crown elements comprise three u-shaped bends are connected to each other at the ends.

3. A valve stent, according to claim 1, wherein the crown elements arranged one behind the other form the valve stent.

4. A valve stent, according to claim 1, wherein each of the crown elements comprise bars and the connection bars are wider than the bars of the crown elements.

5. A valve stent, according to claim 1, wherein valve leaflets are arranged at a distal crown element.

6. A valve stent, according to claim 1, wherein curves of the crown elements have different shapes, wherein a proximal crown element is preferably flatter than a distal crown element of the plurality of crown elements.

7. A valve stent, according to claim 1, wherein the valve stent is self-expanding, wherein the valve stent in a folded state takes an expanded shape due to an elasticity thereof and/or it'"'"'s a shape memory thereof.

8. A valve stent, according to claim 1, wherein the valve stent flares conically from a proximal to a distal end.

9. A valve stent, according to claim 1, further comprising fixing hooks griping into a natural vessel wall.

10. A valve stent, according to claim 9, wherein the fixing hooks are arranged at the base of the distal crown element and are oriented against the flow direction.

11. A valve stent, according to claim 9, wherein the fixing hooks are arranged at the distal ends of a proximal crown element and are oriented with a flow direction.

12. A valve stent, according to claim 9, wherein the fixing hooks are made of the same material as the valve stent.

13. A valve stent, according to claim 1, wherein the fixing hooks are made of a shape memory alloy and are straight during application.

14. A valve stent, according to claim 1, further comprising flexible wires fixed with free ends to two adjacent connection bars.

15. A valve stent, according to claim 14, further comprising clamps, wherein the flexible wires are fixed with the clamps to the connection struts, wherein the clamps and/or the wires are made of a shape memory metal.

16. A valve stent, according to claim 1, further comprising a separate anchoring stent having at least one or more than one crown elements wherein the separate anchoring stent can be placed between the crown elements of the valve stent so that the separate anchoring stent is positioned within the valve stent.

17. A valve stent, according to claim 16, wherein the separate anchoring stent deviates from a circular cylindrical shape.

18. A valve stent, according to claim 16, wherein the separate anchoring stent can be connected to the valve stent via radial expansion of the valve stent.

19. A valve stent, according to claim 1, further comprising a bulb stent that forms artificial bulbs that widen a vessel in a bulb-shaped manner.

20. A valve stent, according to claim 19, wherein cross-shaped stent struts each form one bulb.

21. A valve stent, according to claim 19, further comprising another bulb stent to provide two bulb stents wherein the two bulb stents are axially offset to each other so that the two bulb stents form a diamond-shaped opening in a region of crossing points.

22. A valve stent, according to claim 19, further comprising another bulb stent to provide a plurality of bulbs wherein struts running in an axial direction form the bulbs.

23. A valve stent, according to claim 19, wherein the bulb stent is connected to the valve stent wherein the bulb stent and the connection strut of the valve stent are connected by threads or the bulb stent and the valve stent are welded or glued at points.

24. A valve stent, according to claim 1, further comprising:

fixing hooks; and

a separate anchoring stent having a crown element wherein the separate anchoring stent can be placed between the crown elements of the valve stent so that the separate anchoring stent is positioned within the valve stent and wherein the fixing hooks of the valve stent grab into the anchoring stent.

31. A valve stent, according to claim 1, wherein the valve stent is coated with a coating material, which exhibits hardenings preferably increasing or decreasing from the inside to the outside or hardenings at first increasing and then decreasing.

32. A valve stent, according to claim 31, wherein the coating material is a hyperbranched polymer or a base polymer for silanised polymers.

33. A valve stent, according to claim 31, wherein the stent struts are successively coated with plastics with a decreasing degree of hardness.

34. A valve stent, according to claim 31, wherein the stent struts are first coated with a soft polymer and subsequently with a comparatively harder polymer, wherein the leaflet is connected to the outer, comparatively harder layer.

25. A device for application of a stent having fixing hooks of crown elements or other stent struts, the device comprising:

positioning wires that have clamps connected at the ends in one or two pieces, which can be connected to the fixing hooks of the crown elements or other stent struts in a form-fitting or a force-locking manner.

26. A device according to claim 25, wherein the positioning wires can be introduced and moved at their ends within radially oriented coverings.

27. A device according to claim 25, wherein the positioning wires are glued to the fixing hooks or to another region of the stent.

28. A device according to claim 25, wherein additional flexible tubes which on the one hand supply glue to adhere the stents to an annulus and on the other hand can also be used as a guide to position the valve stent.

29. A device, according to claim 25, wherein a funnel-shaped device arranged around the lock, by which the valve stent can be inserted into the lock of the catheter.

30. A device, according to claim 25, further comprising an elastic flexible tube, in which the valve is arranged and diameter of which is dependent on an axially directed force.

35. A process to produce a valve stent for incorporating polymeric valve leaflets, the process comprising the steps of:

providing a valve stent with a valve stent surface; and

applying a thin-walled, if necessary, partially-formed sandwich structure with varying layer thickness and/or spatially varying degree of hardness to the valve stent surface using 3D droplet dosing technology.

36. A procedure, according to claim 35, wherein the valve leaflets are adapted to the valve stent in a slightly compressed state.

37. A procedure, according to claim 35, wherein the valve stent is first cut from a tube with a smaller diameter, wherein a bar is produced with an excess thickness and is then expanded to the desired diameter and cut exactly to size.