Bioabsorbable polymeric medical device

• US 8,460,364 B2
• Filed: 07/20/2007
• Issued: 06/11/2013
• Est. Priority Date: 07/20/2006
• Status: Active Grant

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: Orbusneich Medical Incorporated (Orbusneich Medical)
• Inventors: Cottone, Robert J., Ye, Shusheng, Pazienza, John
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US11/781,233
• Publication Number:
  US 20080051874A1
• Time in Patent Office: 2,153 Days
• Field of Search: 623/1.22, 623/1.38, 623/1.39
• US Class Current: 623/1.22
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

In embodiments there is described a cardiovascular tube-shaped lockable and expandable bioabsorbable scaffold having a low immunogenicity manufactured from a crystallizable bioabsorbable polymer composition or blend.

Claims

1. A bioabsorbable and flexible scaffold formed from expansion-crystallizable bioabsorbable polymer material and circumferential about a longitudinal axis so as to form a tube, said tube having a proximal open end and a distal open end, and being crimpable and expandable, and having a patterned shape in expanded form comprising:

a first multicomponent strut pattern helically coursing from said proximal open end to said distal open end of said tube;

a nested hoop structure comprising at least one through-hole; and

a second multicomponent strut pattern helically coursing from said proximal open end to said distal open end of said tube;

wherein a component of said first multicomponent strut pattern opposes from about 120°

to about 180°

a component of said second multicomponent strut pattern as each helically courses from said proximal open end to said distal open end of said tube.

2. The scaffold of claim 1 wherein the first multicomponent strut pattern is substantially the same in configuration throughout the scaffold.

3. The scaffold of claim 1 wherein the second multicomponent strut pattern is substantially the same in configuration throughout the scaffold.

4. The scaffold of claim 1 wherein the first and second multicomponent strut patterns are substantially the same in configuration throughout the scaffold.

5. The scaffold of claim 1 wherein the first multicomponent strut pattern that opposes from about 120°

to about 180°

the component of the second multicomponent strut pattern are substantially the same in configuration.

6. The scaffold of claim 5 wherein the components of the first and second multicomponent struts that oppose form a stylized H configuration.

7. The scaffold of claim 5 wherein the components of the first and second multicomponent struts that oppose form a stylized X configuration.

8. The scaffold of claim 5 wherein the components of the first and second multicomponent struts that oppose form a stylized S configuration.

9. The scaffold of claim 5 wherein the components of the first second multicomponent struts that oppose form a stylized 8 configuration.

10. The scaffold of claim 5 wherein the components of the first and second multicomponent struts that oppose form a stylized I configuration.

11. The scaffold of claim 1 further comprising a third multicomponent strut pattern helically coursing from said proximal open end to said distal open end of said tube.

12. The scaffold of claim 11 further comprising a fourth multicomponent strut pattern helically coursing from said proximal open end to said distal open end of said tube.

13. The scaffold of claim 12 further comprising a fifth multicomponent strut pattern helically coursing from said proximal open end to said distal open end of said tube.

14. The scaffold of claim 11, wherein all of the helices of the multicomponent strut patterns turns about said tube in the same handed direction.

15. The scaffold of claim 1 wherein each helix of both of the multicomponent strut patterns turns about said tube in a left-handed screw direction.

16. The scaffold of claim 1 wherein each helix of both of the multicomponent strut patterns turns about said tube in a right-handed screw direction.

17. The scaffold of claim 1 wherein at least one helix of both of the multicomponent strut patterns turns about said tube in a left-handed screw direction while another helix turns in a right-handed screw direction.

18. The scaffold of claim 1 further comprising a locking means.

19. A bioabsorbable and flexible stent circumferential about a longitudinal axis so as to form a tube, said tube having a proximal open end and a distal open end, and being crimpable and expandable, and having a patterned shape in expanded form comprising a plurality of helically coursing multicomponent strut patterns from said proximal open end to said distal open end of said tube, wherein a component of each said multicomponent strut pattern opposes from about 120°

to about 180°

another component of another multicomponent strut pattern as each helically courses from said proximal open end to said distal open end of said tube, and where said stent has at least one hoop structure nested between said multicomponent strut patterns comprising at least one through-hole and is manufactured from a racemic polymer which crystallizes under the strain of expansion of the stent.

20. The stent of claim 19 wherein each helix of the multicomponent strut patterns turns about said stent in a left-handed screw direction.

21. The stent of claim 19 wherein each helix of both of the multicomponent strut patterns turns about said stent in a right-handed screw direction.

22. The stent of claim 19 wherein at least one helix of the multicomponent strut patterns turns in a left-handed screw direction while another helix turns about said stent in a right-handed screw direction.

23. The stent of claim 19, wherein all of the helices of the multicomponent strut patterns turn about said stent in the same handed direction.