Artificial valved conduits for cardiac reconstructive procedures and methods for their production

• US 10,624,737 B2
• Filed: 01/24/2017
• Issued: 04/21/2020
• Est. Priority Date: 07/29/2011
• Status: Active Grant

• Current Assignee: Carnegie Mellon University, University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: Carnegie Mellon University
• Inventors: Yoshida, Masahiro, Bernstein, C. Douglas, Dur, Onur, Pekkan, Kerem
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/413,571
• Publication Number:
  US 20170196685A1
• Time in Patent Office: 1,183 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/367 Muscle tissue, e.g. sphincter
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 29/49412 with assembly, disassembly or composite article making

Abstract

Artificial heart valve structures and methods of their fabrication are disclosed. The heart valve structures may be fabricated from a biocompatible polymer and include one or more heart valve leaflet structures incorporated within a conduit. The valve structures may incorporate one or more conduit sinuses, as well as a gap between the lower margin of the valve leaflets and the interior of the conduit. In addition, the valve structures may include one or more valve sinuses created in a space between the valve leaflets and the conduit inner surface. Computational fluid dynamics and mechanical modeling may be used to design the valve leaflets with optimal characteristics. A heart valve structure may also incorporate a biodegradable component to which cells may adhere The incorporated cells may arise from patient cells migrating to the biodegradable component, or the component may be pre-seeded with cells prior to implantation in a patient.

Claims

1. A valve structure comprising:

a conduit comprising an inner conduit surface; and

a leaflet structure having an open state and a closed state comprising;

a plurality of valve leaflets, each valve leaflet comprising a sinus structure having a sinus edge and a fan structure having a fan edge, wherein at least a portion of the sinus edge is affixed to a portion of the inner conduit surface at two or more points,

wherein, when the leaflet structure is in the open state, at least a portion of the fan edges of the plurality of valve leaflets and at least a portion of the inner conduit surface are mutually disposed to form a valve gap between the sinus edge and the inner conduit surface, and

wherein, when the leaflet structure is in the closed state, at least a portion of the fan edges of the plurality of valve leaflets are mutually disposed to form a single valve gap, or at least a portion of the fan edges of the plurality of valve leaflets and at least a portion of the inner conduit surface are mutually disposed to form a single valve gap.

2. The valve structure of claim 1, wherein the sinus edge comprises a plurality of first sinus edge components.

3. The valve structure of claim 1, wherein the fan edge comprises a fan edge steep portion proximate to the sinus edge, and a fan edge gradual portion.

4. The valve structure of claim 1, wherein at least a portion of the sinus structure and a section of the inner conduit surface are nonadjacent, thereby forming a valve sinus bounded at least in part by at least the section of the inner conduit surface and at least the portion of the sinus structure.

5. The valve structure of claim 1, wherein the valve leaflet has a ratio of a baseline width to a diameter of the conduit of about 1.3 to about 1.7.

6. The valve structure of claim 1, wherein the plurality of valve leaflets comprises two leaflets.