Stent with micro-latching hinge joints

• US 7,628,802 B2
• Filed: 01/17/2006
• Issued: 12/08/2009
• Est. Priority Date: 08/06/2002
• Status: Active Grant

• Current Assignee: Mirus LLC
• Original Assignee: Icon Medical Corp. (ICON Interventional Systems, Inc.)
• Inventors: White, Jason, Stern, David
• Primary Examiner(s): Isabella; David J
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US11/333,485
• Publication Number:
  US 20060111772A1
• Time in Patent Office: 1,421 Days
• Field of Search: 623 111- 154, 606/508
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: Y10T 403/32418 Plural distinct positions

Abstract

A stent is constructed using interconnected links having micro-mechanical latching mechanisms. The micro-mechanical latching elements allow relative rotational movement of interconnected links in one rotational direction but restrict relative rotational movement of the two links in the opposite direction. The micro-mechanical latch surface features are formed using micro-electronic mechanical systems (MEMS) manufacturing methods. The male surface of the latching components contains an array of ridges or protrusions, and the receiving surface contains a matching array of recesses. The array of ridges or protrusions and the corresponding recesses have uniformly dissimilar slopes that result in a substantially greater frictional force in one direction than in the opposite direction. The separation distance between the two surfaces is such that the male latch surface is engaged with the receiving surface recesses in the low stress “locked” state, preventing motion in the undesired direction. Each male ridge or protrusion can be underlined by a void that promotes elastic deflection when sliding in the desired direction and recovery into the ‘locked ’ state when aligned with the recesses.

Claims

1. A method of forming a permanently an expandable medical device, said medical device having a body section that is expandable from a first unexpanded diameter to a second expanded diameter, said second diameter greater than said first diameter, said method comprising the step of forming first and second links in said body section of said medical device, each of said links including at least one link segment, said link segment including a head portion and a support member, said support member having first and second ends, said first end of said support member rotatably connected to said head portion, said first end of said support member and said head portion including an engagement arrangement that has a plurality of engagement surfaces designed to incrementally limit a direction of rotation of said support member in a single direction relative to said head portion, said plurality of engagement surfaces allowing at least a portion of said body section to expand from said first to said second diameter of aid body section and to prevent at least a portion of said expanded body section from contracting in diameter once said support member has rotated a predetermined distance relative to said head portion, wherein said body section at least partially forms a stent.

2. The method as defined in claim 1, wherein said engagement arrangement of said first and second links is designed to limit a direction of rotation of said support member in a single direction relative to said head portion.

3. The method as defined in claim 2, wherein said engagement arrangement of said second link is designed to allow rotation of said support member in a plurality of directions in one portion of said engagement arrangement and designed to limit a direction of rotation of said support member in a single direction relative to said head portion in another portion of said engagement arrangement.

4. The method as defined in claim 1, wherein said engagement arrangement of said first and second links designed to allow rotation of said support member in a plurality of directions in one portion of said engagement arrangement and designed to limit a direction of rotation of said support member in a single direction relative to said head portion in another portion of said engagement arrangement.

5. The method as defined in claim 1, including the step of forming a ratcheting arrangement in said engagement arrangement, at least two of said engagement surfaces of said engagement arrangement at least partially formed from a plurality of teeth, bumps, and combinations thereof and a plurality of recesses.

6. The method as defined in claim 1, including the step of forming a flexible connector between said first and second links, said connector enabling said first and second links to change in distance from one another when said body section is expanded from said first to said second diameter.

7. The method as defined in claim 1, including the step of forming a second engagement arrangement in a second end of at least one support member, said second engagement arrangement designed to limit a direction of rotation of said support member in a single direction relative to another head portion.

8. The method as defined in claim 7, wherein said second engagement arrangement on said second end includes a ratcheting arrangement, said ratcheting arrangement including a plurality of engagement surfaces at least partially formed from a plurality of teeth, bumps, and combinations thereof and a plurality of recesses.

9. The method as defined in claim 1, wherein said body section is at least partially formed from a bio-degradable material.

10. The method as defined in claim 9, wherein said bio-degradable material includes a polymer.

11. The method as defined in claim 1, including the step of inserting, coating, and combinations thereof said body section with a pharmacological agent.

12. The method as defined in claim 1, wherein said step of forming said first and second links includes a process selected from the group consisting of micro machining, photo lithography, electroplating, sacrificial molding, vacuum molding, spin coating, and combinations thereof.

13. The method as defined in claim 1, wherein said step of forming said first and second links includes use of a masking technique to buildup a portion of said first and second links and to dissolve away a portion of said first and second links.

14. The method as defined in claim 1, wherein said first and second links are formed on said body section in a generally planar configuration prior to expansion of said body section, and including the step of repositioning said formed first and second links so that said body section is in a non-planar configuration when said body section is expanded from said first to said second diameter.

15. The method as defined in claim 14, including the step of connecting at least one free end of said first link to said second link to at least partially maintain said non-planar configuration of said body section.

16. The method as defined in claim 14, wherein said non-planar configuration of said body section includes a generally cylindrical expandable tubular-shape.

17. The method as defined in claim 1, wherein said engagement arrangement is a rotary ratchet arrangement having a wheel with angled teeth formed on its periphery.

18. A method of forming an expandable medical device, said medical device in the form of a stent having a body section that is expandable from a first unexpanded diameter to a second expanded diameter, said second diameter greater than said first diameter, said method comprising the step of forming first and second links in said body section of said medical device, each of said links including at least one link segment, said link segment including a head portion and a support member, said support member having first and second ends, said first end of said support member rotatably connected to said head portion, said first end of said support member and said head portion including an engagement arrangement having a plurality of engagement surfaces, a plurality of said engagement surfaces designed to incrementally limit a direction of rotation of said support member in a single direction relative to said head portion, said plurality of engagement surfaces allowing at least a portion of said body section to expand from said first to said second diameter of said body section and to prevent at least a portion of said expanded body section from contracting in diameter once said support member has rotated a predetermined distance relative to said head portion, said engagement arrangement of said first and second links including a ratcheting arrangement, said ratcheting arrangement including a plurality of engagement surfaces at least partially formed from a plurality of teeth, bumps, and combinations thereof and a plurality of recesses, at least a portion of said ratcheting arrangement designed to limit a direction of rotation of said support member in a single direction relative to said head portion.

19. The method as defined in claim 18, wherein said engagement arrangement of said first and second links is designed to limit a direction of rotation of said support member in a single direction relative to said head portion.

20. The method as defined in claim 19, including the step of forming a flexible connector between said first and second links, said connector enabling said first and second links to change in distance from one another when said body section is expanded from said first to said second diameter.

21. The method as defined in claim 20, including the step of forming a second engagement arrangement in said second end of said support member of said first and second links, said second engagement in said second end of said support member of said first and second links designed to limit a direction of rotation of said support member in a single direction relative to another head portion.

22. The method as defined in claim 21, wherein said body section is at least partially formed from said first and second links and including the steps of a) at least partially forming said body section from said first and second links in a generally planar configuration and subsequently repositioning said formed first and second links into a body section having a non-planar configuration, and b) connecting at least one free end of said first link to said second link to at least partially maintain said non-planar configuration of said body section.

23. The method as defined in claim 19, including the step of forming a second engagement arrangement in said second end of said support member of said first and second links, said second engagement in said second end of said support member of said first and second links designed to limit a direction of rotation of said support member in a single direction relative to another head portion.

24. The method as defined in claim 23, wherein said second engagement arrangement on said second end said support member of said first and second links includes a ratcheting arrangement, said ratcheting arrangement including a plurality of engagement surfaces at least partially formed from a plurality of teeth, bumps, and combinations thereof and a plurality of recesses.

25. The method as defined in claim 19, wherein said body section is at least partially formed from a bio-degradable material, said bio-degradable material includes a polymer.

26. The method as defined in claim 19, including the step of inserting, coating, and combinations thereof said body section with a pharmacological agent.

27. The method as defined in claim 19, including the steps of a) at least partially forming said body section from said first and second links in a generally planar configuration and subsequently repositioning said formed first and second links into a body section having a non-planar configuration, and b) connecting at least one free end of said first link to said second link to at least partially maintain said non-planar configuration of said body section.

28. The method as defined in claim 18, wherein said engagement arrangement of said second link is designed to allow rotation of said support member in a plurality of directions in one portion of said engagement arrangement and designed to limit a direction of rotation of said support member in a single direction relative to said head portion in another portion of said engagement arrangement.

29. The method as defined in claim 18, including the step of forming a flexible connector between said first and second links, said connector enabling said first and second links to change in distance from one another when said body section is expanded from said first to said second diameter.

30. The method as defined in claim 18, including the step of forming a second engagement arrangement in said second end of said support member of said first and second links, said second engagement in said second end of said support member of said first and second links designed to limit a direction of rotation of said support member in a single direction relative to another head portion.

31. The method as defined in claim 30, wherein said second engagement arrangement on said second end said support member of said first and second links includes a ratcheting arrangement, said ratcheting arrangement including a plurality of engagement surfaces at least partially formed from a plurality of teeth, bumps, and combinations thereof and a plurality of recesses.

32. The method as defined in claim 18, wherein said body section is at least partially formed from a bio-degradable material, said bio-degradable material includes a polymer.

33. The method as defined in claim 18, including the step of inserting, coating, and combinations thereof said body section with a pharmacological agent.

34. The method as defined in claim 18, including the steps of a) at least partially forming said body section from said first and second links in a generally planar configuration and subsequently repositioning said formed first and second links into a body section having a non-planar configuration, and b) connecting at least one free end of said first link to said second link to at least partially maintain said non-planar configuration of said body section.