Prosthetic cardiovascular valves and methods for replacing native atrioventricular valves with same

1. A method for replacing a defective heart valve, comprising the steps of:

(i) providing a prosthetic valve, said prosthetic valve comprising a base sheet member comprising a polymeric composition,

said base sheet member further comprising an open proximal cardiovascular structure engagement region that is configured to engage an AV valve annulus region, said open proximal cardiovascular structure engagement region being further configured to receive fluid flow therein,

said base sheet member further comprising a closed distal end region that restricts fluid flow therethrough and a plurality of elongated ribbon members that extend from said closed distal end region toward said open proximal cardiovascular structure engagement region, each of said plurality of elongated ribbon members comprising first and second edge regions and proximal and distal ends,

said plurality of elongated ribbon members being positioned circumferentially about said base sheet member where said open proximal cardiovascular structure engagement region is formed, and wherein said first edge regions of said plurality of elongated ribbon members are positioned proximate said second edge regions of said plurality of elongated ribbon members and form a plurality of fluid flow modulating regions between adjacent elongated ribbon members of said plurality of elongated ribbon members,

said base sheet member being configured to expand to an expanded valve configuration when said open proximal cardiovascular structure engagement region is engaged to said AV valve annulus region and said base sheet member receives first fluid flow therein that exhibits a positive flow pressure and contracts to a contracted valve configuration when said base sheet member receives second fluid flow that exhibits a negative flow pressure,

said plurality of fluid flow modulating regions being configured to open during said expansion of said base sheet member to said expanded valve configuration, wherein said plurality of fluid flow modulating regions allow said first fluid flow in said base sheet member to be transmitted through said plurality of fluid flow modulating regions, and close during said contraction of said base sheet member to said contracted valve configuration, wherein said plurality of fluid flow modulating regions restrict said second fluid flow through said plurality of fluid flow modulating regions and, thereby, through said base sheet member;

(ii) providing a catheter assembly adapted to access said AV valve annulus region of a heart, said catheter assembly comprising a portal catheter, catheter guide, anchor insertion device, anchor guidewire, anchor, valve insertion device and valve securing device,

said portal catheter comprising a catheter portal sheath comprising proximal and distal ends and an access portal therein that is sized and configured to receive and route therethrough said catheter guide, said anchor insertion device, said anchor guidewire, said anchor, said valve, insertion device and said valve securing device, said portal catheter further comprising a catheter control assembly adapted to control said portal catheter and, thereby said catheter guide, said anchor insertion device, said anchor guidewire, said anchor, said valve insertion device and said valve securing device when disposed therein,

said catheter guide comprising a guide head and a guide shaft having an internal guide lumen therein that is sized and configure to receive a first guidewire therein, said guide head being configured to pierce through biological tissue,

said anchor insertion device comprising an elongated member having an internal anchor insertion device lumen therein that is sized and configured to receive said anchor guidewire and anchor therein, said anchor insertion device further comprising an actuation mechanism adapted to control said elongated member, said anchor guidewire and anchor when disposed therein,

said anchor guidewire comprising proximal and distal ends, said anchor being disposed on said anchor guidewire distal end, said anchor being configured to engage cardiovascular tissue,

said valve insertion device comprising a valve insertion member and a base member comprising proximal and distal ends and a base member internal lumen therein that is adapted to receive pressurized air therein, said valve insertion device further comprising an expandable member disposed on said distal end of said base member, said expandable member being adapted to transition from a pre-deployment configuration to an expanded post-deployment configuration,

said valve securing device comprising a securing shaft comprising a proximal end and a mold-function distal end that is adapted to position said anchor in said cardiovascular tissue, engage said closed distal end region of said prosthetic valve and sever a guidewire, said valve securing device further comprising at least one valve securing device actuation mechanism that is adapted to control said mold-function distal end;

(iii) preparing a first catheter sub-assembly comprising said portal catheter, said catheter guide and said first guidewire;

(iv) selecting a vein in communication with a subject's heart, said vein providing access to an AV waive annulus region of said subject's heart;

(v) placing an incision through tissue proximate said vein and through said vein, wherein an opening is provided in said vein;

(vi) inserting said first catheter sub-assembly through said incision and into and through said vein, and into a right atrium of said subject's heart;

(vii) advancing said first catheter sub-assembly into a left atrium of said subject's heart;

(viii) retracting said catheter guide and said first guidewire through said access portal of said catheter portal sheath and out of said subject's body;

(ix) inserting said anchor insertion device and said anchor guidewire into said access portal of said catheter portal sheath;

(x) routing said anchor insertion device through said access portal of said catheter portal sheath and into a left ventricle of said subject's heart;

(xi) positioning said anchor of said anchor guidewire at a predetermined anchor attachment point between anterior and posterior papillary muscles;

(xii) attaching said anchor to myocardium of said subject's heart at said predetermined anchor attachment point;

(xiii) withdrawing said anchor insertion device through said access portal of said catheter portal sheath, wherein said anchor and said anchor guidewire remain connected to said myocardium;

(xiv) securing said open proximal cardiovascular structure engagement region and, thereby said proximal ends of said plurality of elongated ribbon members of said prosthetic valve to an expandable proximal guide ring, said expandable proximal guide ring being adapted to transition from a guide ring pre-deployment configuration to a guide ring expanded post-deployment configuration;

(xv) positioning said prosthetic valve on said expandable member of said valve insertion device, wherein said anchor guidewire is routed into and through said prosthetic valve closed distal end region;

(xvi) inserting said valve insertion device with said prosthetic valve engaged thereto into and through said access portal of said catheter portal sheath along said anchor guidewire and into said AV valve annulus region of said subject's heart;

(xvii) positioning said prosthetic valve in said AV valve annulus region;

(xviii) expanding said expandable member of said valve insertion device, wherein said expandable member expands to said expanded post-deployment configuration and, thereby, said base sheet member of said prosthetic valve expands to said expanded valve configuration and said expandable proximal guide ring expands to said guide ring expanded post-deployment configuration, whereby said prosthetic valve is disposed adjacent said AV valve annulus region;

(xix) retracting said valve insertion device through said access portal of said catheter portal sheath and out of said subject's body;

(xx) inserting said valve securing device into and through said access portal of said catheter portal sheath, and into an interior region of said base sheet member of said prosthetic valve;

(xxi) ensnaring said closed distal end region of said prosthetic valve with said multi-function distal end of said valve securing device;

(xxii) connecting said closed distal end region of said base sheet member of said prosthetic valve to said anchor, whereby said prosthetic valve is engaged to said myocardium;

(xxiii) positioning said multi-function distal end of said valve securing device at a predetermined anchor guidewire severing point proximate said anchor;

(xxiv) severing said anchor guidewire at said predetermined anchor guidewire severing point with said valve securing device;

(xxv) withdrawing said valve securing device and said severed anchor guidewire through said access portal of said catheter portal sheath;

(xxvi) inserting a suturing device into and through said access portal of said catheter portal sheath to said open proximal cardiovascular structure engagement region of said base sheet member of said prosthetic valve;

(xxvi) suturing said open proximal cardiovascular structure engagement region to the AV valve annulus region; and

(xxviii) withdrawing said catheter portal sheath out of said left atrium of said subject's heart and out of said subject's body.

2. The method of claim 1 , wherein said step of inserting said first catheter sub-assembly through said incision and into said right atrium of said subject's heart further comprises routing said first catheter sub-assembly up a common iliac vein and into an inferior vena cava.

3. The method of claim 1 , wherein said step of advancing said first catheter sub-assembly into said left atrium of said subject's heart further comprises routing said first catheter sub-assembly through a predetermined region of an atrial septum of said subject's heart.

4. The method of claim 1 , wherein during said method a rapid heart rate is induced in said subject's heart, wherein blood flow to and through said AV valve annulus region is reduced.