Rubber toughened bioresorbable polymer peripheral scaffolds

• US 9,180,228 B2
• Filed: 10/03/2011
• Issued: 11/10/2015
• Est. Priority Date: 10/03/2011
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Stankus, John, Wang, Yunbing, Trollsas, Mikael, Hossainy, Syed Faiyaz Ahmed, Ngo, Michael H., Davalian, Dariush
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US13/252,120
• Publication Number:
  US 20130085563A1
• Time in Patent Office: 1,499 Days
• Field of Search: 623/1.15
• US Class Current: 1/1
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/141 Plasticizers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

Bioabsorbable scaffolds are disclosed with a rigid polymer component and a rubbery polymer component. The rubbery polymer component is miscible, partially miscible, or immiscible with the rigid polymer component.

Claims

1. A medical device, comprising:

a scaffold formed from a polymer tube,

configured for being plastically deformed when crimped to a balloon having a nominal inflation diameter,

the scaffold comprising a plurality of rings, each of the rings having ring struts interconnected at hinge portions, such that the ring struts and hinge portions form a unitary ring,

the scaffold having an expanded diameter when plastically deformed from a crimped state by the balloon inflated to the nominal inflation diameter, and

the hinge portions are plastically deformed when the scaffold is crimped to the balloon and when the scaffold is expanded by the balloon;

wherein the scaffold attains greater than 80% of its expanded diameter after being crushed to at least 50% of its expanded diameter; and

wherein the scaffold is made from a composition including a rigid bioresorbable polymer component having a glass transition temperature (Tg) greater than 37 deg C. and a rubbery polymer component having a Tg less than ambient temperature, wherein the rubbery polymer component is between 1 to 10 wt % of the composition.

9. The medical device of claim 1, wherein the rubbery polymer component is polycaprolactone (PCL).

2. A medical device, comprising:

a scaffold formed from a polymer tube,

configured for being plastically deformed when crimped to a balloon having a nominal inflation diameter,

the scaffold comprising a plurality of rings, each of the rings having ring struts interconnected at hinge portions, such that the ring struts and the hinge portions form a unitary ring,

the scaffold having an expanded diameter when plastically deformed from a crimped state by the balloon inflated to the nominal inflation diameter, and

the hinge portions are plastically deformed when the scaffold is crimped to the balloon and when the scaffold is expanded by the balloon;

wherein the scaffold attains greater than 80% of its expanded diameter after being crushed to at least 50% of its expanded diameter;

wherein the scaffold is made from a composition including a rigid bioresorbable polymer component having a glass transition temperature (Tg) greater than 37 deg C. and a rubbery polymer component having a Tg less than ambient temperature, wherein the rubbery polymer component is between 5 and 25 wt % of the composition; and

wherein the scaffold has a wall thickness of between 0.2 and 0.4 mm and a pre-crimp diameter of between 5-10 mm.

3. The stent of claim 2, wherein the rubbery polymer component is polyethylene glycol (PEG) having a weight average molecular weight (Mw) of 20 kDa or less.

4. The stent of claim 2, wherein the rubbery polymer component is PEG and the PEG is 5 to 10 wt % of the scaffold.

5. The stent of claim 2, wherein the rigid bioresorbable polymer is about 75 to 95 wt % of the scaffold and the rubbery polymer is 5 to 25 wt % of the scaffold.

6. The stent of claim 2, wherein the scaffold has a deploy-to-fracture diameter of about 10 mm and a wall thickness of 0.2 mm.

7. The stent of claim 2, wherein the scaffold has a deploy-to-fracture diameter of between 8 mm and 10 mm and a wall thickness of 0.2 mm.

8. The stent of claim 2, wherein the scaffold has a pre-crimp diameter of 6-8 mm, a deploy-to-fracture diameter of between about 8 mm and 10 mm and a wall thickness of 0.2 mm.