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

1. A method for replacing a defective atrioventricular (AV) valve, comprising the steps of: (i) providing a prosthetic tissue valve comprising a conical shaped sheet member, said sheet member comprising an extracellular matrix (ECM) composition, said ECM composition comprising acellular ECM from a mammalian tissue source, said sheet member further comprising a proximal end configured to engage an AV valve annulus region and a closed distal end, said closed distal end of said sheet member being configured to block fluid flow therethrough, said sheet member further comprising a plurality of linear interstices disposed between said sheet member open proximal annulus engagement end and said closed distal end, said sheet member being configured to expand during positive fluid flow through said sheet member and contract during negative fluid flow through said sheet member, said plurality of linear interstices being configured to open during said expansion of said sheet member, wherein said positive fluid flow is allowed to be transmitted through said plurality of linear interstices, and close during said contraction of said sheet member, wherein said negative fluid flow through said sheet member is restricted; (ii) providing a catheter assembly adapted to access said AV valve annulus region, said catheter assembly comprising a portal catheter, catheter guide, all-in-one (AIO) valve deployment device, anchor guidewire and anchor, said portal catheter comprising a catheter portal sheath comprising portal sheath proximal and distal ends and an access portal therein that is sized and configured to receive and route therethrough said catheter guide, said AIO valve deployment device, said anchor guidewire and said anchor, said portal catheter further comprising a catheter control assembly adapted to control said portal catheter and, thereby said catheter guide, said AIO valve deployment device, said anchor guidewire and said anchor when disposed therein, said catheter guide comprising a guide shaft comprising guide shaft proximal and distal ends, an internal guide shaft lumen therein that is sized and configured to receive a first guidewire therein and a guide head disposed on said guide shaft distal end, said guide head being configured to pierce through biological tissue, said AIO valve deployment device comprising a base member comprising proximal and distal ends and a base member internal lumen therein that is sized and configured to receive said anchor guidewire and anchor therein, said base member internal lumen being further configured to receive pressurized air therein, said AIO valve deployment device further comprising first and second actuation mechanisms adapted to control said base member, and said anchor guidewire and anchor when disposed therein, said AIO valve deployment device further comprising an expandable member disposed proximate said distal end of said base member, said expandable member being in communication with said base member internal lumen and adapted to transition from a pre-deployment configuration to an expanded post-deployment configuration when said pressurized air is received in said base member internal lumen, said AIO valve deployment device further comprising a gating mechanism disposed on said distal end of said base member, said gating mechanism comprising a door region comprising a plurality of door members that are adapted to transition from a closed, coapted configuration to an open configuration, when said anchor guidewire and said anchor are guided into and through said gating mechanism and exert a closure force on said anchor guidewire when said anchor guidewire is disposed in said gating mechanism door region, each of said plurality of door members comprising bladed edges that are adapted to sever said anchor guidewire, said plurality of door members of said gating mechanism being further adapted to engage said anchor guidewire and increase said closure force exerted thereon when said anchor guidewire is retracted through said gating mechanism, wherein said bladed edges of said plurality of door members sever said anchor guidewire, said anchor guidewire comprising anchor guidewire proximal and distal ends, said anchor being disposed on said anchor guidewire distal end, said anchor being configured to engage cardiovascular tissue; (iii) preparing a first catheter sub-assembly comprising said portal catheter, catheter guide and first guidewire; (iv) selecting a vein in communication with a subject's heart for accessing said AV valve annulus region; (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 of said first catheter sub-assembly through said access portal of said portal catheter sheath and out of said subject's body; (ix) positioning said prosthetic tissue valve on said expansion member of said AIO valve deployment device; (x) inserting said AIO valve deployment device with said prosthetic tissue valve engaged thereto into said access portal of said portal catheter sheath; (xi) routing said AIO valve deployment device with said prosthetic tissue valve engaged thereto through said access portal of said portal catheter sheath and into said AV valve annulus region, and positioning said prosthetic tissue valve therein; (xii) expanding said expandable member of said AIO valve deployment device, wherein said expandable member and, thereby, said prosthetic tissue valve transitions to an expanded, post-deployment configuration, whereby said prosthetic tissue valve is disposed adjacent said AV valve annulus region; (xiii) guiding said anchor guidewire into and through said gating mechanism of said AIO valve deployment device; (xiv) positioning said anchor of said anchor guidewire at a predetermined anchor attachment point between anterior and posterior papillary muscles of a left ventricle of said heart; (xv) attaching said anchor to a myocardium of said heart at said anchor attachment point between said anterior and posterior papillary muscles; (xvi) retracting said anchor guidewire through said gating mechanism of said AIO valve deployment device, whereby, said anchor guidewire is severed at a predetermined severing point by said gating mechanism: (xvii) withdrawing said AIO valve deployment device and severed anchor guidewire through said access portal of said portal catheter sheath; and (xviii) 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 the right atrium of said subject's heart further comprises routing said first catheter sub-assembly up an 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 the 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, when said prosthetic tissue valve is disposed adjacent said AV valve annulus region, said proximal end of said prosthetic tissue valve sheet member is disposed adjacent an AV valve annulus in said AV valve annulus region.

5. The method of claim 1 , wherein prior to the step of withdrawing said catheter portal sheath from said left atrium, a suturing device is guided into and through said access portal of said catheter portal sheath and employed to securely stitch said proximal end of said prosthetic tissue valve to a mitral valve region.

6. 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.

7. The method of claim 1 , wherein said vein comprises a femoral vein.

8. The method of claim 1 , wherein said sheet member is configured to induce modulated healing of damaged cardiovascular tissue of said AV valve annulus region concomitantly with stress-induced hypertrophy of said sheet member when said sheet member is engaged to said AV valve annulus region and subjected to cardiac cycle induced physical stimuli, said modulated healing comprising inflammation modulation of said damaged cardiovascular tissue and induced host tissue proliferation, remodeling of said damaged cardiovascular tissue and regeneration of new cardiovascular tissue and tissue structures with site-specific structural and functional properties, said stress-induced hypertrophy of said sheet member comprising adaptive remodeling of said sheet member, wherein said sheet member remodels and forms functioning valve structures that are similar to native valve structures.

9. The method of claim 1 , wherein said sheet member further comprises an anchoring mechanism, said anchoring mechanism being disposed proximate said proximal end of said sheet member.

10. The method of claim 1 , wherein said sheet member further comprises a structural ring, said structural ring being configured to receive said closed distal end therein.

11. The method of claim 1 , wherein said mammalian tissue source is selected from a group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, placental tissue and cardiac tissue.

12. The method of claim 1 , wherein said ECM composition further comprises at least one exogenously added growth factor selected from a group consisting of a transforming growth factor-alpha (TGF-a), transforming growth factor-beta (TGE-3), fibroblast growth factor-2 (FGF-2), and vascular endothelial growth factor (VEGF).