Expandable implantable conduit

• US 10,588,746 B2
• Filed: 03/07/2014
• Issued: 03/17/2020
• Est. Priority Date: 03/08/2013
• Status: Active Grant

• Current Assignee: Carnegie Mellon University
• Original Assignee: Carnegie Mellon University
• Inventors: Bernstein, C. Douglas, Kalra, Arush
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US14/773,048
• Publication Number:
  US 20160015516A1
• Time in Patent Office: 2,202 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/30706 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: G05B 19/4099 Surface or curve machining, making 3D objects, e.g. desktop manufacturing
• CPC Class Codes: G05B 2219/42155 Model

Abstract

An expandable valved conduit for pediatric right ventricular outflow tract (RVOT) reconstruction is disclosed. The valved conduit may provide long-term patency and resistance to thrombosis and stenosis. The valved conduit may enlarge radially and/or longitudinally to accommodate the growing anatomy of the patient. Further, a method is disclosed for the manufacture of the valved conduit based in part on a plastically deformable biocompatible polymer and a computer-optimized valve design developed for such an expandable valved conduit.

Claims

1. An implantable device configured to be plastically deformed using a balloon catheter, the implantable device comprising a fluoropolymer conduit having a yield strength of 0.1 MPa to 3.0 MPa, an ultimate tensile strength greater than 4 MPa, and an internode distance of 10 microns to 60 microns at conditions suitable for implantation into a human or animal.

2. The implantable device of claim 1, wherein the fluoropolymer conduit has a thickness of 0.01 mm to 2 mm.

3. The implantable device of claim 1, wherein the fluoropolymer conduit has a density of 0.2 mg/mm³ to 2 mg/mm³ and an ultimate tensile strength of 5.0 MPa to 5.5 MPa.

4. The implantable device of claim 1, wherein the fluoropolymer conduit has a radial expandability of 20% to 200% above an initial conduit radius.

5. The implantable device of claim 1, wherein the fluoropolymer conduit has a longitudinal expandability of 10% to 200% above an initial conduit length.

6. The implantable device of claim 1, wherein the fluoropolymer conduit comprises at least a first layer and at least a second layer.

7. The implantable device of claim 1, wherein the fluoropolymer conduit further comprises a valve structure.

8. The implantable device of claim 1, wherein the fluoropolymer conduit is configured to be implanted into an adult patient at risk for or having vascular stenosis.

9. The implantable device of claim 1, wherein the fluoropolymer conduit is configured to be implanted into a pediatric patient.

10. The implantable device of claim 1, wherein the fluoropolymer conduit has a radial expandability of 100% to 400% above an initial conduit radius.

11. The implantable device of claim 1, wherein the conditions suitable for implantation into a human or animal are normal physiological conditions.

12. The implantable device of claim 1, wherein the conditions suitable for implantation into a human or animal comprise a temperature of 20 to 40 degrees Celsius.

13. The implantable device of claim 1, wherein the device is implanted into a human.

14. The implantable device of claim 1, wherein the fluoropolymer conduit has a radial expandability of 50% to 200% above an initial conduit radius.

15. The implantable device of claim 1, wherein the yield strength is from 2.5 MPa to 3.0 MPa, the ultimate tensile strength is greater than 5 MPa, and the internode distance is from 10 microns to 40 microns;

and wherein the fluoropolymer conduit has a thickness of 0.2 mm to 2 mm and a radial expandability of 100% to 200% above an initial conduit radius.

16. An implantable device comprising a fluoropolymer conduit having a yield strength of 0.1 MPa to 3.5 MPa, an ultimate tensile strength greater than 4 MPa, and an internode distance of 10 microns to 60 microns at conditions suitable for implantation into a human or animal.

17. The implantable device of claim 16, wherein the implantable device is configured to be plastically deformed using a balloon catheter.