US 12,201,518 B2
Reinforced prosthetic valves
Robert G Matheny, Norcross, GA (US)
Assigned to CorMatrix Cardiovascular, Inc., Roswell, GA (US)
Filed by CorMatrix Cardiovascular, Inc., Roswell, GA (US)
Filed on Feb. 18, 2021, as Appl. No. 17/178,562.
Application 17/178,562 is a continuation in part of application No. 16/440,504, filed on Jun. 13, 2019, granted, now 11,160,903.
Application 17/178,562 is a continuation in part of application No. 16/129,968, filed on Sep. 13, 2018, granted, now 10,952,843.
Application 17/178,562 is a continuation in part of application No. 15/206,833, filed on Jul. 11, 2016, granted, now 10,188,510, issued on Jan. 29, 2019.
Application 17/178,562 is a continuation in part of application No. 14/960,354, filed on Dec. 5, 2015, granted, now 9,907,649, issued on Mar. 6, 2018.
Application 17/178,562 is a continuation in part of application No. 14/229,854, filed on Mar. 29, 2014, granted, now 9,308,084, issued on Apr. 12, 2016.
Prior Publication US 2021/0169647 A1, Jun. 10, 2021
Int. Cl. A61F 2/24 (2006.01); A61L 27/04 (2006.01); A61L 27/06 (2006.01); A61L 27/16 (2006.01); A61L 27/18 (2006.01); A61L 27/22 (2006.01); A61L 27/24 (2006.01); A61L 27/34 (2006.01); A61L 27/36 (2006.01); A61L 27/38 (2006.01); A61L 27/54 (2006.01)
CPC A61F 2/2418 (2013.01) [A61F 2/2457 (2013.01); A61L 27/042 (2013.01); A61L 27/047 (2013.01); A61L 27/06 (2013.01); A61L 27/16 (2013.01); A61L 27/18 (2013.01); A61L 27/225 (2013.01); A61L 27/227 (2013.01); A61L 27/24 (2013.01); A61L 27/34 (2013.01); A61L 27/3625 (2013.01); A61L 27/3633 (2013.01); A61L 27/367 (2013.01); A61L 27/3826 (2013.01); A61L 27/3834 (2013.01); A61L 27/3873 (2013.01); A61L 27/54 (2013.01); A61F 2210/0014 (2013.01); A61F 2230/0067 (2013.01); A61L 2300/402 (2013.01); A61L 2300/406 (2013.01); A61L 2300/408 (2013.01); A61L 2300/41 (2013.01); A61L 2300/414 (2013.01); A61L 2300/416 (2013.01); A61L 2300/42 (2013.01)] 23 Claims
OG exemplary drawing
 
1. A prosthetic valve for modulating fluid flow through an atrioventricular (AV) valve annulus region during cardiac cycles of a heart, said fluid flow exhibiting a plurality of fluid pressures during said cardiac cycles, said prosthetic valve comprising:
a continuous conical shaped biological tissue member and a support structure,
said biological tissue member comprising an adaptive tissue regeneration system adapted to induce modulated healing of cardiovascular tissue of said AV valve annulus region concomitantly with stress-induced hypertrophy of said biological tissue member when said biological tissue member is subjected to cardiac cycle induced physical stimuli,
said modulated healing of said cardiovascular tissue comprising inflammation modulation of said cardiovascular tissue and induced neovascularization, remodeling of said cardiovascular tissue and regeneration of new cardiovascular tissue and tissue structures with site-specific structural and functional properties,
said stress-induced hypertrophy of said biological tissue member comprising adaptive remodeling of said biological tissue member, wherein said biological tissue member forms functioning valve structures that are similar to native valve structures,
said adaptive tissue regeneration system of said biological tissue member comprising a material component and a physical structure component,
said material component comprising mammalian-based tissue derived from a mammalian tissue source,
said physical structure component comprising at least first and second biological tissue sheet members, said first and second biological tissue sheet members comprising a biological tissue multi-sheet structure,
said multi-sheet structure comprising an internal lumen adapted to transmit fluid flow therethrough, a proximal valve annulus engagement end and a distal end,
said proximal valve annulus engagement end being configured to engage said AV valve annulus region,
said proximal valve annulus engagement end of said multi-sheet structure comprising a circumferential ribbon connection region and a plurality of equally spaced ribbons projecting from said circumferential ribbon connection region toward said multi-sheet structure distal end,
each of said plurality of ribbons comprising proximal and distal ends, a first edge region extending from said proximal end of each of said plurality of ribbons to said distal end of each of said plurality of ribbons and a second edge region extending from said proximal end of each of said plurality of ribbons to said distal end of each of said plurality of ribbons,
said proximal end of each of said plurality of ribbons being connected to said circumferential ribbon connection region,
said plurality of ribbons being positioned circumferentially about said circumferential ribbon connection region, wherein said first edge regions of said plurality of ribbons are positioned proximate said second edge regions of said plurality of ribbons, wherein a plurality of fluid flow modulating regions is formed between adjacent ribbons of said plurality of ribbons,
said distal ends of said plurality of ribbons being disposed proximate each other in a joined relationship, wherein said fluid flow through said distal end of said multi-sheet structure is restricted while said fluid flow is allowed to be transmitted through said fluid flow modulating regions when in an open position,
said multi-sheet structure being configured to transition from an expanded position when said proximal valve annulus engagement end of said multi-sheet structure is engaged to said AV valve annulus region, receives said fluid flow therein, and said fluid flow exhibits a first fluid pressure of said plurality of fluid pressures, to a collapsed position when said fluid flow exhibits a second fluid pressure of said plurality of fluid pressures,
said plurality of fluid flow modulating regions being configured to transition from said open position when said multi-sheet structure is in said expanded position, wherein said plurality of fluid flow modulating regions allow said fluid flow to be transmitted through said multi-sheet structure, to a closed position when said multi-sheet structure is in said collapsed position, wherein said plurality of fluid flow modulating regions restrict said fluid flow through said multi-sheet structure,
said support structure comprising an annular ring and a plurality of elongated cardiovascular structure engagement members, each of said plurality of elongated cardiovascular structure engagement members comprising proximal and distal ends,
said annular ring being adapted to transition from a contracted pre-deployment configuration, wherein said annular ring is positioned in said multi-sheet structure lumen, to an expanded post-deployment configuration, whereby, said annular ring is positioned in said multi-sheet structure lumen proximate said proximal valve annulus engagement end, said multi-sheet structure is positioned in said expanded position, wherein said proximal valve annulus engagement end is disposed proximate said plurality of elongated cardiovascular structure engagement members,
said annular ring comprising a first edge region and a second edge region, said proximal ends of said plurality of elongated cardiovascular structure engagement members being connected to said annular ring first edge region and projecting longitudinally therefrom,
said distal ends of said plurality of elongated cardiovascular structure engagement members comprising tissue engaging means adapted to engage a cardiovascular structure,
said support structure being disposed in line with said proximal valve annulus engagement end between said first and second sheet members of said multi-sheet structure, whereby each of said plurality elongated cardiovascular structure engagement members extends through and out of said distal end of said multi-sheet structure.