System and method for applying material to a stent

• US 10,456,245 B2
• Filed: 06/01/2017
• Issued: 10/29/2019
• Est. Priority Date: 05/16/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Paul P., McWilliams, Chris, Cady, Connor, Kratochvil, Cody Jeremiah, Kratochvil, Dylan Joseph
• Primary Examiner(s): Yuan, Dah-Wei D.
• Assistant Examiner(s): Bowman, Andrew J
• Application Number:
  US15/611,406
• Publication Number:
  US 20170325976A1
• Time in Patent Office: 880 Days
• Field of Search: 623 116
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials

Abstract

Methods for applying polymeric material to a stent are disclosed. A mandrel is coupled to a stent body. The stent body comprises an inner surface defining a cavity and an outer surface opposing the internal surface. The stent body also has a length along an axis defined by the mandrel between a first end of the stent body and a second end of the stent body. An electrospun material is applied to at least a portion of the stent external surface and to at least a portion of the mandrel to form a coating sheet. A portion of the coating sheet extends from at least one of the first end or second end of the stent to the mandrel. One or both of the stent and the mandrel are moved to apply at least some of the portion of the coating sheet onto the internal surface of the stent body.

Claims

1. A method of applying an electrospun material to an inner surface of a stent, the method comprising:

coupling a mandrel to a stent body;

wherein the stent body comprises an inner surface defining a cavity and an outer surface opposing the inner surface, and

wherein the stent body has a length along an axis defined by the mandrel between a first end of the stent body and a second end of the stent body;

applying an electrospun material to at least a portion of the stent outer surface and to at least a portion of the mandrel to form a coating sheet;

wherein a portion of the coating sheet extends from at least one of the first end or second end of the stent to the mandrel; and

moving one or both of the stent and the mandrel to apply at least some of the portion of the coating sheet onto the inner surface of the stent body.

2. The method of claim 1, wherein coupling the mandrel to the stent body comprises:

attaching the stent body to a valve holder; and

threading the valve holder onto the mandrel.

3. The method of claim 2, wherein attaching the stent body to the valve holder comprises suturing the stent body to the valve holder.

4. The method of claim 2, wherein:

the stent body comprises a plurality of commissure ends;

the valve holder comprises a plurality of stabilizing legs; and

attaching the stent body to the valve holder comprises attaching each of the plurality of commissure ends to one of the plurality of stabilizing legs.

5. The method of claim 2, further comprising adhering the valve holder to the mandrel.

6. The method of claim 1, wherein:

the mandrel comprises a secondary frame portion; and

the portion of the coating sheet extends from at least one of the first end or second end of the stent to the secondary frame portion of the mandrel.

7. The method of claim 1, further comprising attaching the mandrel to a rotary tool.

8. The method of claim 1, further comprising orienting a spinneret so that the spinneret is directed substantially toward the stent body and substantially perpendicular to the axis defined by the mandrel.

9. The method of claim 8, further comprising placing a voltage between the spinneret and the mandrel.

10. The method of claim 1, wherein applying the electrospun material further comprises concurrently rotating both the mandrel and the stent body about the axis defined by the mandrel and oscillating both the mandrel and the stent body along the axis defined by the mandrel.

11. The method of claim 1, wherein moving one or both of the stent and the mandrel produces an inverted portion of the coating sheet extending inside the cavity of the stent.

12. The method of claim 1, wherein:

the portion of the coating sheet comprises an excess portion that extends axially beyond the second end of the stent body such that that the excess portion is not applied onto the inner surface of the stent body; and

the method further comprises folding the excess portion back to apply at least some of the excess portion onto the outer surface of the stent body.

13. The method of claim 1, further comprising:

providing a filter covering a portion of the stent; and

applying an electrospun material to at least a portion of the outer surface of the stent that is not covered by the filter.

14. A method of applying an electrospun material to an inner surface of a stent, the method comprising:

coupling a mandrel to a stent body;

wherein the stent body comprises an inner surface defining a cavity and an outer surface opposing the inner surface, and

wherein the stent body has a length along an axis defined by the mandrel between a first end of the stent body and a second end of the stent body; and

coupling a secondary frame to the mandrel;

applying an electrospun material to at least a portion of the stent outer surface and to at least a portion of the secondary frame to form a coating sheet;

wherein a portion of the coating sheet extends from at least one of the first end or second end of the stent to the secondary frame; and

moving one or both of the stent and the secondary frame to apply at least some of the portion of the coating sheet onto the inner surface of the stent body.

15. The method of claim 14, wherein:

the stent has a stent diameter;

the secondary frame has a secondary frame diameter; and

the stent diameter is greater than the secondary frame diameter.

16. The method of claim 14, further comprising positioning the stent body so that the stent body is between the secondary frame and the valve holder.

17. The method of claim 14, further comprising positioning the stent body so that the secondary frame extends within the cavity of the stent body.

18. The method of claim 14, wherein applying the electrospun material further comprises concurrently rotating both the stent body and the secondary frame about the axis defined by the mandrel and oscillating both the stent body and the secondary frame along the axis defined by the mandrel.

19. The method of claim 14, wherein moving one or both of the stent and the secondary frame produces an inverted portion of the coating sheet extending inside the cavity of the stent.

20. The method of claim 14, wherein:

the portion of the coating sheet comprises an excess portion that extends axially beyond the second end of the stent body such that that the excess portion is not applied onto the inner surface of the stent body; and

the method further comprises folding the excess portion back to apply at least some of the excess portion onto the outer surface of the stent body.

21. A method of applying an electrospun material to an inner surface of a stent, the method comprising:

providing a stent defining an axis and having

an inner surface,

an outer surface,

a first end,

a second end, and

a central cavity;

extending a mandrel axially within the central cavity of the stent;

rotating the stent and the mandrel along the axis;

applying an electrospun material to at least a portion of the outer surface of the stent, and to at least a portion of the mandrel, while the stent and the mandrel are rotating along the axis, so that a sheet of the electrospun material is formed, tapering from at least one of the first end or the second end of the stent to the mandrel;

moving either or both of the stent and the mandrel along the axis so that at least a portion of the sheet of the electrospun material is inverted within the central cavity of the stent; and

covering at least a portion of the inner surface of the stent with the portion of the sheet of the electrospun material.