Bioabsorbable Polymeric Medical Device

• US 20080051875A1
• Filed: 07/20/2007
• Published: 02/28/2008
• 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, Ye, Shusheng, Pazienza, John
• Granted Patent: US 8,460,362 B2
• Time in Patent Office: Days
• US Class Current: 623/1.16
• 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 flexible scaffold 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 unexpanded form comprising:

a first sinusoidal strut pattern comprising a series of repeated sinusoids defined by an apex section and a trough section, said repeated sinusoids coursing from said proximal open end to said distal open end of said tube;

a second sinusoidal strut pattern comprising a series of repeated sinusoids defined by an apex section and a trough section, said sinusoids of said second sinusoidal strut pattern being about 180°

out of phase to with respect to said apex and said troughs of said first sinusoidal strut pattern;

wherein said second sinusoidal strut pattern is connect to said first sinusoidal strut pattern at at least two points, and wherein said connection at said points is from an apex of a sinusoid of said first sinusoidal pattern to an apex of a sinusoid of said second sinusoidal pattern.

2. The scaffold of claim 1 wherein said first sinusoidal strut pattern and said second sinusoidal strut pattern are repeated multiple times, one after the other to form the scaffold.

3. The scaffold of claim 1 wherein said first sinusoidal strut pattern and said second sinusoidal strut pattern are the same.

4. The scaffold of claim 1 wherein said first sinusoidal strut pattern and said second sinusoidal strut pattern are different.

5. The scaffold of claim 1 wherein said scaffold is made of a biodegradable material.

6. The scaffold of claim 1 wherein said second sinusoidal strut pattern is connected to said first sinusoidal strut pattern at at least three points.

7. The scaffold of claim 1 wherein said second sinusoidal strut pattern is connected to said first sinusoidal strut pattern at at least four points.

8. The scaffold of claim 1 wherein said scaffold is made of a polymer.

9. The scaffold of claim 8 wherein said polymer is a poly-lactide polymer.

10. A biosorbable and flexible scaffold 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 unexpanded form comprising:

a first sinusoidal strut pattern comprising a series of repeated sinusoids defined by an apex section and a trough section, said repeated sinusoids coursing from said proximal open end to said distal open end of said tube;

a second sinusoidal strut pattern comprising a series of repeated sinusoids defined by an apex section and a trough section, said sinusoids of said second sinusoidal strut pattern being in phase with respect to said apex and said troughs of said first sinusoidal strut pattern;

wherein said second sinusoidal strut pattern is connected to said first sinusoidal strut pattern at at least two points, and wherein said connection at said points is from an apex of a sinusoid of said first sinusoidal pattern to an apex of a sinusoid of said second sinusoidal pattern.

11. The scaffold of claim 10 wherein said first sinusoidal strut pattern and said second sinusoidal strut pattern are repeated multiple times, one after the other form the scaffold.

12. The scaffold of claim 10 wherein said first sinusoidal strut pattern and said second sinusoidal strut pattern are the same.

13. The scaffold of claim 10 wherein said first sinusoidal strut pattern and said second sinusoidal strut pattern are different.

14. The scaffold of claim 10 wherein said scaffold is made of a biodegradable material.

15. The scaffold of claim 10 wherein said second sinusoidal strut pattern is connected to said first sinusoidal strut pattern at at least three points.

16. The scaffold of claim 10 wherein said second sinusoidal strut pattern is connected to said first sinusoidal strut pattern at at least four points.

17. The scaffold of claim 10 wherein said scaffold is made of a polymer.

18. The scaffold of claim 17 wherein said polymer is a poly-lactide polymer.