IP Library › Granted Patent US 10,952,845

Granted Patent B2

US 10,952,845 · App. 16/193,669 · Granted Mar 23, 2021

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

Inventor: Robert G Matheny (Norcross, GA)

Assignee: Co-Matrix Cardiovascular, Inc.

A61F2/2418 A61L27/3604 A61L27/3625 A61L27/3629 A61L27/3633 A61L27/50 A61L27/54 A61F2/2433 A61F2/2469 A61F2230/0067 A61F2230/0091 A61L2300/414 A61L2430/20

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Quick Facts

Patent No.: US 10,952,845
App. No.: 16/193,669
Granted: Mar 23, 2021
Kind: B2

External Links

USPTO Patent Center↗ Full Patent PDF↗

Abstract

A percutaneous transseptal surgical implantation method for replacing a defective atrioventricular (AV) valve with a conical shaped prosthetic valve formed from extracellular matrix (ECM) tissue. When the method is employed to replace a native mitral valve, the method positions the prosthetic tissue valve in the mitral valve region, whereby the valve does not obstruct the outflow tract of the aortic valve and prevents the leaflets of the aortic valve from coapting.

Claims (97)

1. A method for replacing a defective atrioventricular (AV) valve, comprising the steps of:

(i) providing a prosthetic tissue valve comprising a base valve member comprising an extracellular matrix (ECM) composition, said ECM composition comprising acellular ECM from a mammalian tissue source,

said base valve member further comprising an open proximal annulus engagement end configured to engage an AV valve annulus region and a base valve member distal end,

said base valve member further comprising a plurality of ribbon members that extend from said base valve member open proximal annulus engagement end to said base valve member distal end, each of said plurality of ribbon members comprising ribbon member proximal and distal ends, each of said plurality of ribbon members further comprising first and second edge regions,

said plurality of ribbon members being positioned circumferentially about said base valve member, wherein said first edge regions of said plurality of ribbon members are positioned proximate said second edge regions of said plurality of ribbon members and form a plurality of contiguous ribbon edge regions,

said ribbon member distal ends being positioned proximate each other in a constrained relationship, wherein fluid flow through said constrained ribbon member distal ends is restricted,

said base valve member being configured to expand to an expanded valve configuration during positive fluid flow through said base valve member and contract to a contracted valve configuration during negative fluid flow,

said plurality of contiguous ribbon edge regions being configured to open during said expansion of said base valve member to said expanded valve configuration, wherein said positive fluid flow is allowed to be transmitted through said plurality of contiguous ribbon edge regions, and close during said contraction of said base valve member to said contracted valve configuration, wherein said negative fluid flow through said base 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, anchor insertion device, anchor guidewire, anchor, valve insertion device and valve securing device,

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 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 shaft comprising guide shaft proximal and distal ends, an internal guide shaft lumen therein that is sized and configure 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 anchor insertion device comprising an elongated member comprising 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 anchor guidewire 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, a base member comprising proximal and distal ends and 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 multi-function distal end that is adapted to position said anchor in said cardiovascular tissue, engage said plurality of ribbon members and sever guidewires, said valve securing device further comprising at least one valve securing device actuation mechanism that is adapted to control said multi-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 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 and said first guidewire of said first catheter sub-assembly 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 the 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 of said left ventricle;

(xii) attaching said anchor to myocardium of said subject's heart at said oredetermined anchor attachment point between said anterior and posterior papillary muscles;

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

(xiv) positioning said prosthetic tissue valve on said expandable member of said valve insertion device;

(xv) inserting said valve insertion device with said prosthetic tissue 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, and positioning said prosthetic tissue valve therein;

(xvi) expanding said expandable member of the valve insertion device, wherein said expandable member expands to said expanded post-deployment configuration and, thereby, said base valve member transitions to said expanded valve configuration, whereby said prosthetic tissue valve is disposed adjacent said AV valve annulus region;

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

(xviii) inserting said valve securing device into and through said access portal of said catheter portal sheath, and into an interior region of said prosthetic tissue valve;

(xix) ensnaring said ribbon member distal ends with said multi-function distal end of said valve securing device and connecting said ribbon member distal ends to said anchor, whereby said base valve member distal end is engaged to said myocardium;

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

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

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

(xxiii) 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 said step of routing said anchor insertion device through said access portal of said catheter portal sheath and into said left ventricle of said subject's heart further comprises routing said anchor insertion device through said AV valve annulus region.

5. The method of claim 4 , wherein said step of routing said anchor insertion device through said access portal of said catheter portal sheath, into said left ventricle and through said AV valve annulus region further comprises routing said anchor insertion device through a native AV valve disposed in said AV valve annulus region.

6. The method of claim 1 , wherein, when said prosthetic tissue valve is disposed adjacent said AV valve annulus region, said open proximal annulus engagement end of said base valve member is disposed adjacent an AV valve annulus in said AV valve annulus region.

7. 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 open proximal annulus engagement end of said base valve member to said AV valve annulus region.

8. 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.

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

10. The method of claim 1 , wherein said prosthetic tissue valve is configured to induce modulated healing of damaged cardiovascular tissue of said AV valve annulus region concomitantly with stress-induced hypertrophy of said prosthetic tissue valve when said base valve member open proximal annulus engagement end and, thereby, said prosthetic tissue valve 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 prosthetic tissue valve comprising adaptive remodeling of said prosthetic tissue valve, wherein said prosthetic tissue valve remodels and forms functioning valve structures that are similar to native valve structures.

11. The method of claim 1 , wherein said base valve member further comprises a microneedle anchoring mechanism, said microneedle anchoring mechanism comprising a plurality of microneedles adapted to engage biological tissue, said microneedle anchoring mechanism being disposed proximate said open proximal annulus engagement end of said base valve member.

12. The method of claim 1 , wherein said base valve member further comprises a structural ring, said structural ring being configured to receive said plurality of ribbon members therein.

13. The method of claim 1 , wherein said mammalian tissue source is selected from the 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.

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

15. 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 an open proximal annulus engagement 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 to an expanded valve configuration during positive fluid flow through said sheet member and contract to a contracted valve configuration during negative fluid flow,

said plurality of linear interstices being configured to open during said expansion of said sheet member to said expanded valve configuration, 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 to said contracted valve configuration, wherein said negative fluid flow through said sheet member is restricted;

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