DEVICE AND METHOD FOR PROVIDING A STENT FOR IMPLANTATION

• US 20110152995A1
• Filed: 06/09/2009
• Published: 06/23/2011
• Est. Priority Date: 07/04/2008
• Status: Active Grant

• Current Assignee: Qvanteq AG
• Original Assignee: Qvanteq AG
• Inventors: Mader, Armin W., Zucker, Arik
• Granted Patent: US 8,904,846 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2250/0092 Means for cleaning prostheses

Abstract

A device and a method for providing a stent for implantation into a body lumen are provided, wherein the stent (3) has a proximal end (31) and a distal end (32), between which a stent lumen having a compressible diameter d extends. The device comprises a crimping apparatus (4), having elements (40) which are disposed about an axis and can be moved at least partially relative to each other radially to the axis, and an activator (42) for actuating the crimping apparatus (4). The elements (40) of the crimping apparatus comprise the stent (3) and can be moved radially by means of the activator (42) from a widened position, in which the stent (3) is not crimped, into a closed position, in which the diameter d of the stent (3) is compressed. According to the invention, a storage compartment comprising an inert medium or an inert filling is provided, which forms a jacket in which the stent (3) is stored in an inert manner at least the majority of the time, while the elements (40) enclose the stent (3) and are moved from the widened position into the closed position. The inert jacket can be interrupted during compression of the stent.

Claims

1. A device for providing a stent for implantation into a body lumen, wherein the stent has a proximal end and a distal end, with a stent lumen with a compressible diameter d extending therebetween and comprising

a crimping apparatus with elements, which are arranged around an axis and movable radially with respect to the axis relative to one another, and

an activator for actuating the crimping apparatus,

wherein the elements encompass the stent and are movable in the radial direction from a dilated position, in which the stent is uncrimped, into a closed position, in which the stent has a compressed diameter d, by the activator,

wherein provision is made for a storage space, which includes an inert medium or an inert filling and forms an envelope in which the stent is at least for most of the time stored in an inert fashion while the elements encompass the stent and are movable from the dilated position into the closed position.

2. The device as claimed in claim 1, wherein the crimping apparatus is arranged outside of the storage space of the stent.

3. The device as claimed in claim 1, further comprising a packaging, in which the stent is stored in an inert fashion, provided as the storage space.

4. The device as claimed in claim 3, wherein the packaging has a malleable wall.

5. The device as claimed in claims 3, wherein an access is provided for feeding the packaging with the stent between the elements of the crimping apparatus.

6. The device as claimed in claim 1, wherein at least the elements of the crimping apparatus are provided within the storage space in which the stent is arranged.

7. The device as claimed in claim 1, wherein the activator is arranged outside of the storage space in which the stent is provided.

8. The device of claim 1, further comprising a protective sheath provided between the stent and the elements.

9. The device as claimed in claim 1, wherein the elements have an inert surface, at least in those regions where they contact the stent.

10. The device as claimed in claim 1, wherein the elements at least in part include an inert material.

11. The device as claimed in claim 1, wherein the surface of the elements has a hydrophilic property.

12. The device as claimed in claim 1, wherein the storage space is provided by a container, which is filled with an inert gas that is heavier than air.

13. The device as claimed in claim 1, wherein the storage space is provided as a gas cloud that envelopes the stent or as a wetting film on the surface of the stent.

14. The device as claimed in claim 1, wherein the stent is for most of the time stored in an inert fashion such that provision can be made for a break in the inert envelope over a period of time during which there is no significant recontamination of the stent surface.

15. The device as claimed in claim 14, wherein the period during which the inert envelope is broken does not exceed approximately 15 minutes.

16. The device as claimed in claim 1, wherein at least a distal end of a catheter is provided within the storage space in order to hold the stent in the compressed state, wherein a balloon catheter or a tube catheter is assigned in a complementary fashion to a balloon-expanding or a self-expanding stent.

17. The device as claimed in claim 16, wherein the proximal end of the catheter protrudes out of the storage space through an access.

18. A method for providing a stent for implantation into a body lumen, wherein the stent has a proximal end and a distal end, with a stent lumen with a compressible diameter d extending therebetween, comprising:

storing the stent in a storage space including an inert medium or comprising an inert filling, which forms an envelope for the stent, and

compressing the stent using a crimping apparatus with moveable elements, which encompass the stent and are moved from a dilated position into a closed position, wherein the stent remains in the inert envelope or a break in the inert envelope is provided over a period of time during which there is no significant contamination of a surface of the stent or no significant increase in a contact angle of a water droplet on the surface of the stent.

19. The method as claimed in claim 18, wherein the inert envelope is broken during the compression of the stent.

20. The method as claimed in one of claims 18, further comprising carrying out a cleaning treatment before or during the inert storage of the stent, as a result of which, as a measure of the hydrophilicity, the contact angle of a water droplet situated on the surface is reduced compared to the contact angle before this treatment.

21. The method as claimed in claim 20, wherein the molecular-chemical contaminants originating from the atmosphere, mainly hydrocarbons, are significantly reduced on the surface of the stent during the cleaning treatment.

22. The method as claimed in claim 18, further comprising storing the stent in a packaging with an inert filling after the compression.

23. The method as claimed in claim 18, further comprising sterilizing the stent after the compression.

24. The method as claimed in claim 18, wherein during the progression of the method steps of the cleaning treatment, the storage, the compression, the packaging and optionally the sterilizing, the stent remains in the inert envelope or provision is made for a break in the inert envelope over a period of time during which there is no significant contamination on a surface of the stent or no significant increase in a contact angle of a water droplet on the surface of the stent.

25. The method as claimed in claim 18, wherein the storage space is provided by a packaging of the stent, which packaging is inserted into the crimping apparatus.

26. The method as claimed in claim 18, wherein the crimping apparatus is at least in part stored in an inert fashion and actuated from outside of the storage space.

27. The method as claimed in claim 18, wherein as a result of a treatment there is a significant reduction in molecular-chemical contaminants originating from the atmosphere, mainly hydrocarbons, on a surface of elements of the crimping apparatus, which elements contact the stent to compress the stent.

28. The method as claimed in claim 18, further comprising storing the stent is stored in a first inert medium or a first inert filling before the break in the inert envelope, and in a second inert medium or a second inert filling after the break in the inert envelope.

29. The method as claimed in claim 18, further comprising arranging the stent at a distal end of a catheter during the inert storage, wherein the stent is compressed onto a balloon at the distal end of the catheter in the case of a balloon-expanding stent, and wherein the stent is compressed by the crimping apparatus and subsequently inserted into the distal end of a tube catheter in the case of a self-expanding stent.