Endoluminal device exhibiting improved endothelialization and method of manufacture thereof

• US 6,820,676 B2
• Filed: 12/22/2000
• Issued: 11/23/2004
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Banas, Christopher E., Palmaz, Julio C., Sprague, Eugene A., Wiseman, Roger W., Marton, Denes, Simon, Cristina
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US09/745,304
• Publication Number:
  US 20010001834A1
• Time in Patent Office: 1,432 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.32, 623/1.44, 623/901, 204/192.15, 205/151, 205/165, 427/2.1, 427/2.24, 427/2.25, 427/295, 164/46, 164/76.1, 298/966, 216/8
• US Class Current: 164/46
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: C23C 14/0005 Separation of the coating from the substrate
• CPC Class Codes: C23C 14/16 on metallic substrates or on substrates of boron or silicon
• CPC Class Codes: C23C 14/18 on other inorganic substrates
• CPC Class Codes: C23C 14/22 characterised by the process of coating
• CPC Class Codes: C23C 14/30 by electron bombardment
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

An implantable endoluminal device which is fabricated from materials which present a blood or body fluid and tissue contact surface which has controlled heterogeneities in material constitution. An endoluminal stent which is made of a material having controlled heterogeneities in the stent material along the blood flow surface of the stent and the method of fabricating the stent using vacuum deposition methods.

Claims

1. A method of manufacturing an implantable endoluminal device capable of radially expanding from a first diameter to a second diameter comprising the steps of:

a. vacuum depositing a device-forming metal onto an unpatterned, exterior surface of a generally cylindrical substrate at a deposition rate that controls a formation of heterogeneities in the metal to form a generally tubular, unpatterned, substantially homogeneous metal film on the exterior surface of the substrate;

b. forming a pattern of openings through the deposited generally tubular, unpatterned, substantially homogeneous metal film to form the implantable endolumina) device, whereby the pattern of openings provide a plurality of geometric deformation regions that permit radial expansion of the implantable endoluntinal device; and

c. removing the iniplantable endoiwninal device from the substrate.

2. The method according to claim 1, further comprises the step of depositing a sacrificial material layer onto the substrate prior to step (a) and removing the sacrificial material layer in order to remove the implantable endoluminal device from the substrate in step (c).

3. The method according to claim 1, wherein step (a) is conducted by ion beam-assisted evaporative deposition.

4. The method according to claim 3, wherein the ion beam-assisted evaporative deposition is conducted in the presence of an inert gas.

5. The method according to claim 4, wherein the inert gas is selected from the group consisting of argon, xenon, nitrogen and neon.

6. The method according to claim 1, wherein step (a) is conducted by sputtering.

7. The method according to claim 1, wherein the deposition rate is at least about 20 nm/sec.

8. The method according to claim 1, wherein the deposition rate is between about 10-100 microns/hour.

9. The method according to claim 1, wherein during the deposition of the device-forming metal, a deposition chamber pressure is less than about 2×

10<sup>−

7</sup> torr.

10. The method according to claim 1, wherein during the deposition of the device-forming metal, the substrate is rotated.

11. The method according to claim 1, wherein during the deposition of the device-forming metal, a substrate temperature is between about 300 and 1100°

C.

12. A method of making an implantable medical device comprising the steps of:

a. providing a substrate having a shaped exterior surface capable of accommodating metal deposition thereupon;

b. vacuum depositing a biocompatible material onto the shaped exterior surface of the substrate at a deposition rate, with a substrate temperature, and at a deposition chamber pressure that controls a formation of heterogeneities on a surface of a biocompatible material layer; and

c. forming the implantable medical device from the, deposited biocompatible material, wherein the deposition rate is at least about 20 nm/sec. the deposition chamber pressure is less than about 2×

10<sup>−

7</sup> torr, and the substrate temperature is between about 300 and 1100°

C.

13. A method of making an implantable medical device comprising the stens of:

a. providing a substrate having a shaped exterior surface capable of accommodating metal deposition thereupon;

b. vacuum depositing a a biocompatible material onto the shaped exterior surface of the substrate at a deposition rate, with a substrate temperature, and at a deposition chamber pressure that controls a formation of heterogeneities on a surface of a biocompatible material layer; and

c. forming the implantable medical device from the deposited biocompatible material, wherein the deposition rate is between about 10-100 microns/hour, the deposition chamber pressure is less than about 2×

10<sup>−

7</sup> torr, and the substrate temperature is between about 300 and 1100°

C.

14. The method according to claim 13, wherein control of heterogeneities further comprises controlling at least one of grain size, grain phase, grain material composition, material composition and surface topography during vacuum deposition.