Endoluminal device exhibiting improved endothelialization and method of manufacture thereof

• US 7,625,594 B2
• Filed: 11/22/2004
• Issued: 12/01/2009
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Simon, Cristina, Banas, Christopher E., Palmaz, Julio C., Sprague, Eugene A., Wiseman, Roger W., Marton, Denes
• Primary Examiner(s): Meeks; Timothy H
• Assistant Examiner(s): Sellman; Cachet I
• Application Number:
  US10/994,770
• Publication Number:
  US 20050072544A1
• Time in Patent Office: 1,835 Days
• Field of Search: 427/2.24, 427/2.1, 427/2.25, 427/256, 427/261, 427/264, 427/294, 427/331, 427/372.2, 164/46, 623/1.15, 623/1.13
• US Class Current: 427/2.24
• 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 a shape memory material, comprising the steps of:

a) providing a generally cylindrical substrate having an outer surface capable of accommodating metal deposition thereupon;

b) vacuum depositing a metal onto the outer surface of the generally cylindrical substrate to form an unpatterned metal film on said outer surface of said generally cylindrical substrate, at least one of deposition chamber vacuum pressure, substrate temperature and bias voltage being controlled during the vacuum deposition to define a substantially homogeneous distribution of binding domains for endothelial cell attachment on the unpatterned metal film;

c) defining a pattern of a plurality of openings passing through the deposited unpatterned metal film on the outer surface of the generally cylindrical substrate; and

d) removing the generally cylindrical substrate from the patterned deposited metal film formed thereupon.

2. The method according to claim 1, wherein step b) further comprises controlling formation of heterogeneities at a surface of the unpatterned metal film which interfaces with the generally cylindrical substrate, the heterogeneities being selected from the group consisting of grain size, grain phase, grain material composition or surface topography.

3. The method according to claim 1, wherein the deposited patterned metal film obtained from step d) is characterized by having substantially homogeneous surface energy and electrostatic charge across a blood contact surface of the metal film.

4. The method according to claim 1, further comprising the step of controlling deposition chamber pressure to a pressure less than or equal to about 2×

10<sup>−

7</sup> Torr.

5. The method according to claim 1, further comprising the step of controlling the substrate temperature to between about 300 and 1100 degrees Centigrade.

6. The method according to claim 1, further comprising the step of controlling the bias voltage to between about −

1000 and +1000 volts applied to the generally cylindrical substrate.

7. The method according to claim 6, further comprising controlling the bias voltage to impart a hyperthermal energy of energetic species arriving at the surface of the substrate to between about 0.1 eV and about 700 eV.

8. The method according to claim 7 wherein the hyperthermal energy of the energetic species is between about 5 to about 50 eV.

9. The method according to claim 1, further comprising the step of pre-cleaning the generally cylindrical substrate by glow discharge.

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

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

12. The method according to claim 1, wherein the metal is selected from the group consisting of at least one of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, neobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum alloy, chromium-cobalt alloy, shape memory nickel-titanium alloy, and stainless steel.

13. 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) pre-cleaning the substrate in a vacuum deposition chamber by glow discharge;

c) vacuum depositing a biocompatible material onto the shaped exterior surface of the substrate while controlling formation of heterogeneities in surfaces of the biocompatible material by controlling at least one of deposition chamber vacuum pressure, substrate temperature and substrate bias voltage, to define a substantially homogeneous distribution of binding domains for endothelial cell attachment to the surface of the deposited biocompatible material, the substantially homogeneous distribution of binding domains comprising a substantially repeating pattern along a blood contact surface of the surface of the deposited biocompatible material, the repeating pattern having a border-to-border spacing between adjacent binding domains of between about 1 to 2 microns;

d) patterning the implantable medical device in the deposited biocompatible material; and

e) removing the substrate from the patterned implantable medical device.

14. The method according to claim 13, wherein the patterned implantable medical device obtained from step d) is characterized by having substantially homogeneous surface energy and electrostatic charge across a blood contact surface thereof.

15. The method according to claim 13, further comprising the step of controlling deposition chamber pressure to a pressure less than or equal to about 2×

10<sup>−

7</sup> Torr.

16. The method according to claim 13, further comprising the step of controlling the substrate temperature to between about 300 and 1100 degrees Centigrade.

17. The method according to claim 13, further comprising the step of controlling the bias voltage to between about −

1000 and +1000 volts applied to the generally cylindrical substrate.

18. The method according to claim 17, further comprising controlling the bias voltage to impart a hyperthermal energy of energetic species arriving at the surface of the substrate to between about 0.1 eV and about 700 eV.

19. The method according to claim 18, wherein the hyperthermal energy of the energetic species is between about 5 to about 50 eV.