PROFILE REDUCTION SEAL

• US 20130090729A1
• Filed: 10/05/2012
• Published: 04/11/2013
• Est. Priority Date: 10/05/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Gregg, Peter W., Paul, David J., Brandt, Brian D., Khokhar, Rajan
• Granted Patent: US 9,474,598 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2210/0076 multilayered, e.g. laminated structures
• 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 2250/0069 Sealing means
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

The disclosure pertains to profile reduction seals associated with heart valve replacements which may reduce or eliminate paravalvular regurgitation and methods of fabricating such seals. The generally cylindrical multilayer seals of the disclosure include a crown-like end and reinforcing elements which facilitate compression of the seal and associated device by minimizing bunching of the seal as it enters a delivery system.

Claims

1. A profile reduction seal for a heart valve replacement comprising:

a multilayer, generally cylindrical seal body having a distal end, a proximal end, and a lumen therebetween;

a plurality of reinforcing grommets disposed and distributed proximate the proximal end of the multilayer, generally cylindrical seal body; and

a distal reinforcing band disposed proximate the distal end of the multilayer, generally cylindrical seal body, wherein the proximal end of the multilayer, generally cylindrical seal body comprises a plurality of alternating projections and recesses.

2. The profile reduction seal of claim 1, wherein at least some of the plurality of reinforcing grommets are disposed within the plurality of projections of the proximal end of the multilayer, generally cylindrical seal body.

3. The profile reduction seal of claim 1, wherein at least some of the plurality of reinforcing grommets are disposed within the multilayer, generally cylindrical seal body and proximate the recesses of the proximal end of the multilayer, generally cylindrical seal body.

4. The profile reduction seal of claim 1, wherein at least some of the plurality of reinforcing grommets are disposed within the multilayer, generally cylindrical seal body and distal of the plurality of projections of the proximal end of the multilayer, generally cylindrical seal body and distal of the recesses of the proximal end of the multilayer, generally cylindrical seal body.

5. The profile reduction seal of claim 1, wherein the plurality of reinforcing grommets include one or more perforations, said one or more perforations extending through both the plurality of reinforcing grommets and the multilayer, generally cylindrical seal body.

6. The profile reduction seal of claim 1, wherein distal reinforcing band includes a plurality of perforations, said plurality of perforations extending through both the distal reinforcing band and the multilayer, generally cylindrical seal body.

7. The profile reduction seal of any of claims 1, wherein the multilayer, generally cylindrical seal body comprises a radially innermost outer layer comprising a polycarbonate and a polyurethane.

8. The profile reduction seal of any of claims 1, wherein the multilayer, generally cylindrical seal body further comprises a radially outermost outer layer comprising a polycarbonate and a polyurethane.

9. The profile reduction seal of any of claims 1, wherein the multilayer, generally cylindrical seal body comprises at least one inner layer disposed between the radially outermost outer layer and the radially innermost outer layer, said at least one inner layer disposed between the radially outermost outer layer and the radially innermost outer layer.

10. The profile reduction seal of claim 9, wherein the at least one inner layer disposed between the radially outermost outer layer and the radially innermost outer layer has a modulus of elasticity less than the modulus of elasticity of the radially innermost outer layer and less than the modulus of elasticity of the radially outermost outer layer.

11. The profile reduction seal of any of claims 9, wherein the at least one inner layer disposed between the radially outermost outer layer and the radially innermost outer layer has an elongation to break greater than the elongation to break of the radially innermost outer layer and greater than the elongation to break of the radially outermost outer layer.

12. The profile reduction seal of any of claims 1, wherein the plurality of reinforcing grommets comprises a woven fabric.

13. The profile reduction seal of any of claims 1, wherein the distal reinforcing band comprises a woven fabric.

14. A method of forming a profile reduction seal for a heart valve replacement comprising:

positioning a cleaned tapered seal-forming mandrel in a coating apparatus;

applying a first coating composition comprising a carrier and at least one polymer to the cleaned tapered mandrel;

removing the carrier from the first coating composition thereby forming a first coated mandrel;

positioning a distal reinforcing band to encircle the first coated mandrel;

positioning a plurality of grommets on the first coated mandrel;

applying a second coating composition comprising a carrier and at least one polymer to the first coated mandrel, the distal reinforcing band, and the plurality of grommets;

removing the carrier from the second coating composition thereby forming a second coated mandrel;

applying a third coating composition comprising a carrier and at least one polymer to the first coated mandrel;

removing the carrier from the third coating composition thereby forming a profile reduction seal precursor;

confirming that the profile reduction seal precursor is fully formed and meets thickness specifications;

trimming the profile reduction seal precursor to conform to dimensional specifications; and

removing the profile reduction seal from the tapered seal-forming mandrel.

15. The method of claim 14, wherein the coating apparatus is a spray coating apparatus.

16. The method of any of claims 14, wherein the first coating composition comprises a polycarbonate and a polyurethane.

17. The method of any of claims 14, wherein the second coating composition comprises a polycarbonate and a polyurethane.

18. The method of any of claims 14, wherein the third coating composition comprises a polycarbonate and a polyurethane.

19. The method of any of claims 14, wherein the first coating composition is different from the second coating composition.

20. The method of any of claims 14, wherein the second coating composition is different from the third coating composition.