Metallic implantable grafts and method of making same

• US 9,132,001 B2
• Filed: 11/09/2012
• Issued: 09/15/2015
• Est. Priority Date: 11/19/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Banas, Christopher E., Palmaz, Julio C.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/673,168
• Publication Number:
  US 20130131784A1
• Time in Patent Office: 1,040 Days
• Field of Search: 623/1.15, 623/1.22, 623/1.28, 623/1.3, 623/1.31, 623/1.32, 623/1.33, 623/1.39, 623/1.4
• US Class Current: 1/1
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• 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: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C23C 14/0005 Separation of the coating from the substrate
• CPC Class Codes: Y10T 83/04 Processes

Abstract

Implantable medical grafts fabricated of metallic or pseudometallic films of biocompatible materials having a plurality of microperforations passing through the film in a pattern that imparts fabric-like qualities to the graft or permits the geometric deformation of the graft. The implantable graft is preferably fabricated by vacuum deposition of metallic and/or pseudometallic materials into either single or multi-layered structures with the plurality of microperforations either being formed during deposition or after deposition by selective removal of sections of the deposited film. The implantable medical grafts are suitable for use as endoluminal or surgical grafts and may be used as vascular grafts, stent-grafts, skin grafts, shunts, bone grafts, surgical patches, non-vascular conduits, valvular leaflets, filters, occlusion membranes, artificial sphincters, tendons and ligaments.

Claims

1. A method of making an implantable medical graft comprising the steps of:

a. Providing a generally tubular implantable medical graft having a continuous cross section, the generally tubular implantable medical graft comprising a graft-forming material selected from the group consisting of biocompatible metals and pseudometals, the graft forming material including circumferential corrugations defined by a radially undulating pattern of longitudinally alternating radially extending peaks and valleys in an abluminal wall surface of the graft-forming material and a radially undulating longitudinally alternating pattern of radially extending peaks and valleys in a luminal wall surface of the graft-forming material, wherein each peak in the luminal surface is longitudinally coincident with each peak in the abluminal surface and each valley in the luminal surface is longitudinally coincident with each valley in the abluminal surface, wherein the peaks and valleys are disposed along at least a portion of the longitudinal axis of the graft-forming material and at least one of a plurality of non-undulated circumferential regions is positioned at the end regions of the graft-forming material; and

b. forming a plurality of microperforations disposed through the corrugations defined by coincident peaks and the coincident valleys wherein the plurality of microperforations in combination with the corrugations provide recoverable compliance to the graft.

2. The method of claim 1, wherein forming the plurality of microperforations comprises:

a. Masking regions that are to remain; and

b. Removing material from the unmasked regions.

3. The method of claim 2, wherein removing material comprises etching.

4. The method of claim 3, wherein the etching method is selected from the group comprising wet chemical etching processing or dry chemical etching processing.

5. The method of claim 2, wherein removing material comprises machining.

6. The method of claim 5, wherein the machining method is selected from the group comprising laser ablation, electrical discharge machining, electrochemical machining, cutting, or grinding.

7. The method according to claim 1, further comprising the step of forming at least one of a plurality of openings with suture retention strength through the wall thickness of at least one non-undulating region of the graft-forming material.