Gradually self-expanding stent

• US 8,764,813 B2
• Filed: 12/23/2008
• Issued: 07/01/2014
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Jantzen, Alexandra E., Irwin, Nathaniel A., Melsheimer, Jeffry S.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Woznicki, Jacqueline
• Application Number:
  US12/342,302
• Publication Number:
  US 20100161033A1
• Time in Patent Office: 2,016 Days
• Field of Search: 623/1.38, 623/1.3, 623/1.31, 623 111- 113
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A gradually self-expanding stent includes a first plurality of stent cells including a first plurality of circumferentially adjacent structural members in mechanical communication with each other. The stent also includes a second plurality of stent cells including a second plurality of circumferentially adjacent structural members in mechanical communication with each other. The circumferentially adjacent structural members of the first and second plurality of stent cells have a compressed configuration and an expanded configuration. A restraining material is attached to each of the circumferentially adjacent structural members defining each of the second plurality of stent cells such that it substantially covers an entirety of each of the second plurality of stent cells in the compressed configuration. Over time, the restraining material releases the structural members defining each of the second plurality of stent cells, thereby allowing the second plurality of stent cells to assume the expanded configuration.

Claims

1. A self-expanding stent, comprising:

a stent structure comprising a first plurality of stent cells, each of said first plurality of stent cells comprising first and second bends, said first and second bends facing each other and being longitudinally spaced apart, a plurality of structural members interconnecting said first and second bends, wherein each structural member has a length, wherein each of said first plurality of stent cells is defined by said first and second bends and said lengths of said plurality of structural members, wherein said stent cells have a compressed configuration and an expanded configuration; and

a biodegradable restraining material attached to said first plurality of stent cells along the entire length of said structural members in said compressed configuration, said restraining material extending across an entirety of an area defined by said first and second bends and said plurality of structural members of each of said first plurality of stent cells, said restraining material thereby extending longitudinally across each of said areas between said first and second bends and circumferentially across each of said areas between said plurality of structural members disposed adjacent each other,

whereby said restraining material initially restrains said first plurality of stent cells in said compressed configuration, and wherein as said restraining material biodegrades over time throughout each of said areas, said restraining material releases said plurality of structural members of said first plurality of stent cells over time, thereby allowing said first plurality of stent cells to assume said expanded configuration.

2. The self-expanding stent according to claim 1, wherein said stent structure further comprises a second plurality of stent cells having an open and unrestrained structure.

3. The self-expanding stent of claim 2, wherein said second plurality of stent cells are dispersed amongst said first plurality of stent cells in a longitudinally uniform arrangement.

4. The self-expanding stent of claim 2, wherein said second plurality of stent cells are dispersed amongst said first plurality of stent cells in a circumferentially uniform arrangement.

5. The self-expanding stent of claim 4, wherein said restraining material gradually releases said plurality of structural members defining said first plurality of stent cells over different time periods in different stent cells of said first plurality of stent cells.

6. The self-expanding stent of claim 4, wherein said second plurality of stent cells is disposed at a longitudinally central portion of said stent structure.

7. The self-expanding stent of claim 6, wherein a proportion of said first plurality of stent cells to said second plurality of stent cells in said central portion is substantially equal.

8. The self-expanding stent according to claim 1, wherein said restraining material does not extend around the circumference of said stent structure in a continuous manner.

9. The self-expanding stent of claim 1, wherein said restraining material comprises a plurality of layers having varying degradation rates.

10. The self-expanding stent of claim 1, wherein said restraining material comprises one layer having a substantially uniform degradation rate.

11. A self-expanding stent, comprising:

a stent structure comprising a plurality of stent cells comprising interconnected structural members, said structural members each having a length;

a proximal end portion extending toward a longitudinal center of a said stent structure from a proximal end thereof by an amount based on an overall length of said stent structure;

a distal end portion extending toward said longitudinal center of said stent structure from a distal end thereof by an amount based on an overall length of said stent structure; and

a central portion disposed between said proximal and distal end portions,

wherein stent cells of said proximal and distal end portions are comprised of a first plurality of stent cells, and stent cells of said central portion are comprised of both said first plurality of stent cells and a second plurality of stent cells,

wherein each stent cell in said first and second plurality of stent cells comprises first and second bends, said first and second bends facing each other and being longitudinally spaced apart, and being interconnected by said structural members, wherein each of said first and second plurality of stent cells is defined by said first and second bends and said plurality of structural members,

wherein said first plurality of stent cells have an open and unrestrained structure,

wherein said first and second plurality of stent cells have a compressed configuration and an expanded configuration; and

a biodegradable restraining material attached to said second plurality of stent cells along the entire length of said structural members in said compressed configuration, said restraining material extending across an entirety of an area defined by said first and second bends and said plurality of structural members of each of said second plurality of stent cells, said restraining material thereby extending longitudinally across each of said areas between said first and second bends and circumferentially across each of said areas between said plurality of structural members disposed adjacent each other, and

wherein said restraining material initially restrains said second plurality of stent cells in said compressed configuration, wherein as said restraining material degrades over time throughout each of said areas, said restraining material releases said plurality of structural members of said second plurality of stent cells over time, thereby allowing said second plurality of stent cells to assume said expanded configuration.

12. The self-expanding stent of claim 11, wherein a proportion of said first plurality of stent cells to said second plurality of stent cells in said central portion is substantially equal.

13. The self-expanding stent of claim 11, wherein said central portion further comprises an intermediate portion, wherein said restraining material of said second plurality of stent cells disposed in said intermediate portion is configured to release said first and second structural members less quickly than said restraining material for stent cells of said second plurality of stent cells disposed outside of said intermediate portion.

14. The self-expanding stent of claim 13, wherein said restraining material of said stent cells disposed within said intermediate portion is thicker than said restraining material of said stent cells disposed outside of said intermediate portion.

15. The self-expanding stent of claim 13, wherein said intermediate portion comprises a proximal intermediate portion and a distal intermediate portion, wherein said proximal intermediate portion extends toward said longitudinal center of said stent structure from a distal end of said proximal end portion by a predetermined amount, and said distal intermediate portion extends toward said longitudinal center of said stent structure from a proximal end of said distal end portion by the predetermined amount, and wherein said predetermined amount is based on a length of said central portion.

16. The self-expanding stent of claim 15, wherein said predetermined amount is between 10 and 30 percent of the length of said central portion.

17. The self-expanding stent of claim 16, wherein said biodegradable material substantially covering said second plurality of stent cells disposed in said intermediate portion is made of a material that degrades at a slower rate than said biodegradable material substantially covering said stent cells disposed outside of said intermediate portion.

18. A self-expanding stent, comprising:

a proximal end portion extending toward a longitudinal center of a stent structure from a proximal end thereof by an amount based on an overall length of said stent structure;

a distal end portion extending toward said longitudinal center of said stent structure from a distal end thereof by an amount based on an overall length of said stent structure; and

a central portion disposed between said proximal and distal end portions, wherein stent cells of said proximal and distal end portions are comprised of a first plurality of stent cells, and stent cells of said central portion are comprised of both said first plurality of stent cells and a second plurality of stent cells, a proportion of said first plurality of stent cells to said second plurality of stent cells in said central portion being substantially equal,

wherein each stent cell in said first and second plurality of stent cells comprises first and second bends, said first and second bends facing each other and being longitudinally spaced apart, a plurality of structural members interconnecting said first and second bends, each structural member having a length, wherein each of said first and second plurality of stent cells is defined by said first and second bends and said plurality of structural members,

wherein said first plurality of stent cells have an open and unrestrained structure,

wherein said first and second plurality of stent cells have a compressed configuration and an expanded configuration; and

a biodegradable restraining material attached to said second plurality of stent cells along the entire length of said structural members in said compressed configuration, said restraining material extending across an entirety of an area defined by said first and second bends and said plurality of structural members of each of said second plurality of stent cells, said restraining material thereby extending longitudinally across each of said areas between said first and second bends and circumferentially across each of said areas between said plurality of structural members disposed adjacent each other, and

wherein said restraining material initially restrains said second plurality of stent cells in said compressed configuration, wherein as said restraining material degrades over time throughout each of said areas, said biodegradable material releases said plurality of structural members of said second plurality of stent cells over time thereby allowing said second plurality of stent cells to assume said expanded configuration.

19. A self-expanding stent, comprising:

a stent structure comprising braided structural members, said plurality of braided structural members each having a length and forming

a first plurality of stent cells, each of said first plurality of stent cells comprising first and second intersections, said first and second intersections facing each other and being longitudinally spaced apart, said plurality of said structural members interconnecting said first and second intersections, wherein each of said first plurality of stent cells is defined by said first and second intersections and said plurality of said structural members,

wherein said stent cells have a compressed configuration and an expanded configuration; and

a biodegradable restraining material attached to said first plurality of stent cells along the entire length of said structural members in said compressed configuration, said restraining material extending across an entirety of an area defined by said first and second intersections and said plurality of said structural members of each of said first plurality of stent cells, said restraining material thereby extending longitudinally across each of said areas between said first and second bends and circumferentially across each of said areas between said plurality of structural members disposed adjacent each other,

wherein said restraining material initially restrains said first plurality of stent cells in said compressed configuration, and wherein as said restraining material biodegrades over time throughout each of said areas, said restraining material releases said plurality of structural members of said first plurality of stent cells over time, thereby allowing said first plurality of stent cells to assume said expanded configuration.

20. The self-expanding stent according to claim 19, further comprising a second plurality of stent cells having an open and unrestrained configuration.

21. The self-expanding stent of claim 20, wherein said second plurality of stent cells is disposed at a longitudinally central portion of said stent structure.

22. The self-expanding stent of claim 20, wherein said second plurality of stent cells are dispersed amongst said first plurality of stent cells in a circumferentially and longitudinally uniform arrangement.

23. The self-expanding stent according to claim 19, wherein said restraining material does not extend around the circumference of said stent structure in a continuous manner.

24. The self-expanding stent of claim 23, wherein said restraining material gradually releases said plurality of structural members defining said first plurality of stent cells over different time periods in different stent cells of said first plurality of stent cells.

25. The self-expanding stent of claim 19, wherein said restraining material comprises one layer having a substantially uniform degradation rate.

26. A self-expanding stent, comprising:

a stent structure comprising a plurality of stent cells, each of said plurality of stent cells comprising first and second bends, said first and second bends facing each other and being longitudinally spaced apart, a plurality of structural members interconnecting said first and second bends, each structural member having a length, wherein each of said first plurality of stent cells is defined by said first and second bends and said plurality of structural members,

wherein said stent cells have a compressed configuration and an expanded configuration; and

a restraining material attached to said plurality of stent cells along the entire length of said structural members in said compressed configuration, said restraining material extending across an entirety of an area defined by said first and second bends and said plurality of structural members of each of said plurality of stent cells, said restraining material thereby extending longitudinally across each of said areas between said first and second bends and circumferentially across each of said areas between said plurality of structural members disposed adjacent each other,

wherein said restraining material initially restrains said plurality of stent cells in said compressed configuration, and wherein said area stretches over time from a restrained area in which said stent cells are in said compressed configuration, to a larger released area in which said stent cells are in said expanded configuration, wherein each of said areas stretches from said restrained area to said released area due to a radially outward force exerted on said restraining material by said plurality of structural members.