Methods of making medical devices

• US 9,375,330 B2
• Filed: 02/11/2014
• Issued: 06/28/2016
• Est. Priority Date: 11/19/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Sims, Daniel D., Steinmetz, Jeffrey N., Mullens, Conor P., Wood, Alexander Parker, Banas, Christopher E.
• Primary Examiner(s): CHEN, BRET P
• Application Number:
  US14/177,978
• Publication Number:
  US 20140216637A1
• Time in Patent Office: 868 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: B29C 59/04 using rollers or endless belts
• CPC Class Codes: B29C 59/043 for profiled articles
• CPC Class Codes: C23C 14/24 Vacuum evaporation
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 156/1043 Subsequent to assembly

Abstract

Methods for making the medical devices consist of either providing or forming a scaffold, then depositing a metallic or pseudometallic film cover onto the scaffold in such a manner as to form an integral, substantially monolithic junction between the deposited cover material and the scaffold.

Claims

1. A method of making a medical device having a covered scaffold comprising the steps of:

providing a scaffold comprising a plurality of scaffold members separated by interstitial regions;

forming a cover member on a surface of the plurality of scaffold members by an additive methodology, the cover member extending across the interstitial regions; and

creating a plurality of openings passing through the cover member.

2. The method of claim 1, wherein the step of providing the scaffold further comprises the steps of:

forming a substrate pattern region on a surface of a substrate, the substrate pattern region comprising recesses corresponding to a desired pattern for the scaffold;

depositing a scaffold forming material on the surface of the substrate with the desired pattern to fill the substrate pattern regions; and

planarizing the substrate by removing the scaffold forming material to the surface of the substrate so that scaffold forming material remains in the substrate pattern regions to form the plurality of scaffold members.

3. The method of claim 2 further comprising the step of cleaning the surface of the planarized substrate and scaffold forming material.

4. The method of claim 3 where the step of cleaning the surface of the planarized substrate and scaffold forming material comprises using glow discharge cleaning.

5. The method of claim 1 where the step of forming the substrate pattern regions comprises:

engaging a patterning member with the substrate.

6. The method of claim 5 where the step of engaging a patterning member comprises either:

using an embossing die having pattern forming regions corresponding to the desired pattern for the scaffold;

or

using a gravure plate having pattern forming regions corresponding to the desired pattern for the scaffold.

7. The method of claim 1 further comprising the step of releasing the joined cover and scaffold from the deposition substrate.

8. The method of claim 1 where the additive methodology comprises deposition.

9. The method of claim 1 where the additive methodology comprises lamination.

10. The method of claim 1 where the step of providing scaffold comprises the step of using a pre-existing scaffold, and the step of forming the cover member comprises:

mounting the scaffold on a substrate;

forming a layer of sacrificial material over the scaffold on the substrate;

planarizing the layer of sacrificial material by removing sacrificial material sufficient to expose the surface of the plurality of scaffold members while leaving sacrificial material to cover the substrate in the interstitial regions between the plurality of scaffold members;

depositing a cover material over the sacrificial material to contact the exposed surface of the plurality of scaffold members; and

removing the substrate and the sacrificial material from the joined cover member and scaffold.

11. The method of claim 10 further comprising the step of cleaning the surface of the planarized sacrificial material and exposed surface of the scaffold members.

12. The method of claim 11 where the step of cleaning the surface of the planarized sacrificial material and exposed surface of the scaffold members comprises using glow discharge cleaning.

13. A method of making a medical device comprising:

forming a substrate pattern region on a surface of a substrate, the substrate pattern region comprising recesses corresponding to a desired pattern for a scaffold;

depositing a scaffold forming material on the surface of the substrate with the desired pattern to fill the substrate pattern regions;

planarizing the substrate by removing the scaffold forming material to the surface of the substrate so that scaffold forming material remains in the substrate pattern regions to form the plurality of scaffold members separated by interstitial regions;

forming a cover member on a surface of the plurality of scaffold members by an additive methodology, the cover member extending across the interstitial regions; and

creating a plurality of openings passing through the cover member.

14. The method of claim 13 further comprising the step of cleaning the surface of the planarized substrate and scaffold forming material.

15. The method of claim 14 where the step of cleaning the surface of the planarized substrate and scaffold forming material comprises using glow discharge cleaning.

16. The method of claim 13 where the step of forming the substrate pattern regions comprises:

engaging a patterning member with the substrate.

17. The method of claim 16 where the step of engaging a patterning member comprises either:

using an embossing die having pattern forming regions corresponding to the desired pattern for the scaffold;

or

using a gravure plate having pattern forming regions corresponding to the desired pattern for the scaffold.

18. A method of making a medical device having a covered scaffold comprising the steps of:

mounting a pre-existing scaffold on a substrate, the pre-existing substrate comprising a plurality of scaffold members separated by interstitial regions;

forming a layer of sacrificial material over the scaffold on the substrate;

planarizing the layer of sacrificial material by removing sacrificial material sufficient to expose the surface of the plurality of scaffold members while leaving sacrificial material to cover the substrate in the interstitial regions between the plurality of scaffold members;

depositing a cover material over the sacrificial material to contact the exposed surface of the plurality of scaffold members and extend across the interstitial regions;

creating a plurality of openings passing through the cover member; and

removing the substrate and the sacrificial material from the joined cover member and scaffold.

19. The method of claim 18 further comprising the step of cleaning the surface of the planarized sacrificial material and exposed surface of the scaffold members.

20. The method of claim 19 where the step of cleaning the surface of the planarized sacrificial material and exposed surface of the scaffold members comprises using glow discharge cleaning.