Methods of making medical devices

• US 8,647,700 B2
• Filed: 08/21/2012
• Issued: 02/11/2014
• Est. Priority Date: 01/31/2006
• 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, Andrew Parker, Banas, Christopher E.
• Primary Examiner(s): CHEN, BRET P
• Application Number:
  US13/590,613
• Publication Number:
  US 20120325774A1
• Time in Patent Office: 539 Days
• Field of Search: 427/2.1, 427/2.24, 427/2.25, 427/264, 427/271, 623/1.12, 623/1.15, 623/1.2, 623/1.31, 623/1.27
• US Class Current: 427/2.24
• 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

Scaffold-supported metal or pseudometallic film covers suitable for use as medical devices are disclosed together with methods of fabricating the devices. 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:

a. Providing a cover member;

b. Forming a scaffold on a surface of the cover member, by an additive methodology; and

c. Creating a plurality of openings passing through the cover member.

2. The method of claim 1, wherein the cover member is pre-fabricated.

3. The method of claim 1, wherein the step of providing the cover member further comprises the steps of:

i. Providing a deposition substrate;

ii. Forming a pattern associated with the deposition substrate corresponding to a geometry for the cover member; and

iii. Forming the cover member in association with the deposition substrate.

4. The method of claim 3, further comprising the step of releasing the joined cover and scaffold from the deposition substrate.

5. The method of claim 1, wherein the additive methodology comprises deposition.

6. The method of claim 1, wherein the additive methodology comprises lamination.

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

a. Providing a cover member;

b. Forming a scaffold in association with the cover member, by a subtractive methodology that imparts a pattern of support members to the cover member by removing at least some regions of the cover member to create thinner and thicker cover regions; and

c. Creating a plurality of openings passing through the cover member.

8. The method of claim 7, wherein the cover member is pre-fabricated.

9. The method of claim 7, wherein the step of providing the cover member further comprises the steps of:

i. Providing a deposition substrate;

ii. Forming a pattern associated with the deposition substrate corresponding to a geometry for the cover member; and

iii. Forming the cover member in association with the deposition substrate.

10. The method of claim 9, wherein the cover member is formed of a shape memory alloy having an austenite phase transition temperature greater than 37°

C.

11. The method of claim 9, wherein the cover member is sputter deposited.

12. The method of claim 7, wherein the subtractive methodology comprises etching.

13. The method of claim 12, wherein etching further comprises masking regions that will form the support members and exposing unmasked regions to an etchant.

14. The method of claim 13, further comprising forming a second cover member with a void plenum between the cover member and the second cover member.

15. The method of claim 14, further comprising the step of loading at least one pharmacologically agent into the void plenum between the cover member and the second cover member.