Implantable medical devices with enhanced visibility, mechanical properties and biocompatability

• US 8,333,798 B2
• Filed: 09/30/2004
• Issued: 12/18/2012
• Est. Priority Date: 11/07/2003
• Status: Active Grant

• Current Assignee: Merlin MD Pte. Ltd.
• Original Assignee: Merlin MD Pte. Ltd.
• Inventors: Rudakov, Leon, O'Connor, Michael, Gandhi, Deepak
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US10/578,806
• Publication Number:
  US 20070067009A1
• Time in Patent Office: 3,001 Days
• Field of Search: 623/1.15, 623/1.34
• US Class Current: 623/1.15
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00149 Platinum or Pt-based alloys

Abstract

An implantable mechanical device for insertion into a passage, where the device is made from a platinum alloy selected from the group consisting of platinum:iridium alloy, platinum:tungsten alloy, platinum:rhodium:ruthenium alloy, platinum:rhodium alloy and platinum:nickel alloy.

Claims

1. A stent for insertion into a bodily vessel for treatment of an aneurysm or ischemic diseases,

wherein the stent is made from a platinum:

rhodium;

ruthenium alloy comprising a composition of about 75-80% of platinum, 12-18% of rhodium and 5-10% of ruthenium;

wherein the stent comprises a generally tubular structure having an exterior surface defined by a plurality of interconnected struts having a plurality of interstitial spaces therebetween, the stent having a sidewall thickness between about 0.0012 inches and 0.0028 inches;

wherein the plurality of interstitial spaces have been cut from a sheet of metal forming the stent;

wherein the stent is sized to be positioned entirely within an intracranial vessel; and

wherein the stent comprises a self-expandable latticework of struts, the struts being interconnected to form a plurality of rings, the stent further comprising first ring connectors and second ring connectors, the first ring connectors connecting only two adjacent rings, the two adjacent rings being axially spaced relative to each other, the second ring connectors connecting only three adjacent rings, the three adjacent rings being axially spaced relative to each other, wherein at a given circumferential position of the stent, all of the first and second ring connectors are axially spaced from each other, the struts (i) each having a thickness and width of less than 0.0028 inches, (ii) providing even wall coverage along the length of the stent, and (iii) providing a stent surface to length ratio from 1.1-1.3 mm²/mm, such that the stent expands with a force equal to or less than 4 atm and has a flexibility such that deflection of 1 mm from a neutral line occurs with less than 8 grams of force.

2. The stent according to claim 1, wherein said generally tubular structure is expandable from a first position to a second position, wherein said tubular structure expands radially outwardly to the second position such that the exterior surface of said structure engages with the inner surface of the bodily vessel so as to maintain a fluid pathway through said bodily vessel.

3. The stent according to claim 1, wherein the surface of the stent is modified by passive coatings.

4. The stent according to claim 3, wherein the coating comprises iridium oxide or titanium nitrate.

5. The stent according to claim 3, wherein the stent is coated with an external layer containing a pharmaceutically effective amount of therapeutic substances.

6. The stent according to claim 1, further comprising markers to enhance visibility and radiopacity of the device.

7. The stent according to claim 6, wherein the markers include end markers or center markers.

8. A delivery system for inserting a stent according to claim 1, within a bodily vessel, wherein the stent is self-expandable, the delivery system comprising a delivery catheter and the stent, wherein the stent is mounted onto a distal portion of the delivery catheter.

9. A stent according to claim 1, wherein the stent comprises a material ratio in the range of about 12% to about 16%.

10. A stent according to claim 1, wherein the stent has a profile of about 0.020 inches in compressed delivery mode.

11. A stent for insertion into a bodily vessel for treatment of an aneurysm or ischemic diseases,

wherein the stent is made from a platinum:

rhodium alloy comprising a composition of about 65-75% of platinum and 25-35% of rhodium;

wherein the stent comprises a generally tubular structure having an exterior surface defined by a plurality of interconnected struts having a plurality of interstitial spaces therebetween, the stent having a sidewall thickness between about 0.0012 inches and 0.0028 inches;

wherein the plurality of interstitial spaces have been cut from a sheet of metal forming the stent;

wherein the stent is sized to be positioned entirely within an intracranial vessel; and

wherein the stent comprises a self-expandable latticework of struts, the struts being interconnected to form a plurality of rings, the stent further comprising first ring connectors and second ring connectors, the first ring connectors connecting only two adjacent rings, the two adjacent rings being axially spaced relative to each other, the second ring connectors connecting only three adjacent rings, the three adjacent rings being axially spaced relative to each other, wherein at a given circumferential position of the stent, all of the first and second ring connectors are axially spaced from each other, the struts (i) each having a thickness and width of less than 0.0028 inches, (ii) providing even wall coverage along the stent, and (iii) providing a stent surface to length ratio from 1.1-1.3 mm²/mm, such that the stent expands with a force equal to or less than 4 atm and has a flexibility such that deflection of 1 mm from a neutral line occurs with less than 8 grams of force.

12. The stent according to claim 11, wherein said generally tubular structure is expandable from a first position to a second position, wherein said tubular structure expands radially outwardly to the second position such that the exterior surface of said structure engages with the inner surface of the bodily vessel so as to maintain a fluid pathway through said bodily vessel.

13. The stent according to claim 11, wherein the surface of the stent is modified by passive coatings.

14. The stent according to claim 13, wherein the coating comprises iridium oxide or titanium nitrate.

15. The stent according to claim 13, wherein the stent is coated with an external layer containing a pharmaceutically effective amount of therapeutic substances.

16. The stent according to claim 11, further comprising markers to enhance visibility and radiopacity of the device.

17. The stent according to claim 16, wherein the markers include end markers or center markers.

18. A delivery system for inserting a stent according to claim 11, within a bodily vessel, wherein the stent is self-expandable, the delivery system comprising a delivery catheter and the stent, wherein the stent is mounted onto a distal portion of the delivery catheter.

19. A stent according to claim 11, wherein the stent comprises a material ratio in the range of about 12% to about 16%.

20. A stent according to claim 11, wherein the stent has a profile of about 0.020 inches in compressed delivery mode.