Device and method for providing a stent for implantation

• US 8,904,846 B2
• Filed: 06/09/2009
• Issued: 12/09/2014
• Est. Priority Date: 07/04/2008
• Status: Active Grant

• Current Assignee: Qvanteq AG
• Original Assignee: Qvanteq AG
• Inventors: Zucker, Arik, Mder, Armin W.
• Primary Examiner(s): TOLAN, EDWARD THOMAS
• Application Number:
  US13/002,380
• Publication Number:
  US 20110152995A1
• Time in Patent Office: 2,009 Days
• Field of Search: 72/38, 72/39, 72/40, 72/41, 72/42, 724/01, 723/701.3, 723/702.5, 724/02, 292/37, 292/82, 292/835, 534/53, 535/59, 623/1.11, 623/1.15
• US Class Current: 72/402
• 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 is hydrophilized and has a proximal end and a distal end, with a stent lumen with a compressible diameter extending therebetween, the device comprising:

a crimping apparatus with crimping 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 crimping 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, by the activator, and

the device further comprising an inert medium in a storage space, configured for receiving the stent, and which forms an envelope configured for storing the stent is stored in an inert fashion while the crimping 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, configured for storing the stent in an inert fashion in the inert medium, 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 claim 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 the storage space is provided by a container, which is filled with an inert filling that is heavier than air.

7. The device as claimed in claim 1, wherein the stent is for stored in an inert fashion so as to permit a break in the inert envelope over a period of time during which there is no significant recontamination of the stent surface.

8. 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.

9. The device as claimed in claim 8, wherein the proximal end of the catheter protrudes out of the storage space through an access.

12. The device method as claimed in claim 1, wherein the period during which the inert envelope is broken does not exceed approximately 15 minutes.

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

storing the stent in a storage space including an inert medium, configured for receiving the stent, which forms an envelope for the stent, and

compressing the stent using a crimping apparatus with moveable crimping 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.

11. The method as claimed in claim 10, wherein the inert envelope is broken during the compression of the stent.

13. The method as claimed in claim 10, further comprising storing the stent in a packaging with an inert filling after the compression.

14. The method as claimed in claim 10, further comprising sterilizing the stent after the compression.

15. The method as claimed in claim 10, wherein the storage space is provided by a packaging configured for storing the stent, which packaging is inserted into the crimping apparatus.

16. The method as claimed in claim 10, further comprising storing the stent 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.

17. The method as claimed in claim 10, 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.

18. The method as claimed in claim 10, further comprising performing a cleaning treatment before or during the storing step, as a result of which, as a measure of hydrophilicity, the contact angle of a water droplet situated on the surface is reduced compared to the contact angle before the treatment.

19. The method as claimed in claim 18, wherein the molecular-chemical contaminants originating from the atmosphere, mainly hydrocarbons, are significantly reduced on the surface of the stent during the cleaning treatment.

20. 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.