Systems, Apparatus and Methods for Sealing Perivalvular Leaks

• US 20150073548A1
• Filed: 09/11/2014
• Published: 03/12/2015
• Est. Priority Date: 09/11/2013
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G.
• Granted Patent: US 9,737,399 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

An expandable member that is configured to engage an interior region of a prosthetic valve and capable of transitioning from a pre-deployment configuration at a pre-deployment temperature, where the expandable member is capable of being positioned in the valve at an interior valve region when the valve is disposed in a cardiovascular structure, to a post-deployment configuration when the expandable member is subjected to cardiovascular tissue temperature, where an outer surface region of the valve proximate the interior valve region is placed in intimate contact with host cardiovascular tissue of the cardiovascular structure at a first position and seals perivalvular leaks present at the first cardiovascular structure position.

Claims

1. A perivalvular leak sealing apparatus, comprising:

a biocompatible, expandable member that is configured to engage an interior region of a prosthetic cardiovascular valve, said valve having an outer surface,

said expandable member comprising a biocompatible shape memory alloy, said expandable member being capable of transitioning from a pre-deployment configuration at a first temperature, wherein said expandable member is capable of being positioned in said valve at a first interior valve region when said valve is disposed in a cardiovascular structure, said cardiovascular structure comprising host cardiovascular tissue having a first tissue temperature,

to a post-deployment configuration when said expandable member is disposed proximate said cardiovascular tissue and subjected to said first tissue temperature, wherein, when said expandable member is disposed in said first interior valve region of said valve, a first outer surface region proximate said first interior valve region is disposed in intimate contact with said host cardiovascular tissue of said cardiovascular structure at a first cardiovascular structure target position, and wherein a perivalvular leak present at said first cardiovascular structure target position is sealed.

2. The sealing apparatus of claim 1, wherein said biocompatible shape memory alloy comprises Nitinol®

.

3. A perivalvular leak sealing apparatus, comprising:

a biocompatible, expandable member that is configured to engage an interior region of a prosthetic cardiovascular valve, said valve having an outer surface,

said expandable member comprising a bioremodelable extracellular matrix (ECM) material from a mammalian tissue source,

said expandable member being capable of transitioning from a pre-deployment configuration, wherein said expandable member is capable of being positioned within said valve at a first interior valve region when said valve is disposed in a cardiovascular structure,

to a post-deployment configuration, wherein, when said expandable member is disposed in said first interior valve region of said valve, a first outer surface region of said valve proximate said first interior valve region is disposed in intimate contact with host cardiovascular tissue of said cardiovascular structure at a first cardiovascular structure target position and abates at least one perivalvular leak present at said first cardiovascular structure target position during a first sealing stage, and wherein, after a first period of time after said first valve region is placed in said intimate contact with said host cardiovascular tissue of said cardiovascular structure at said first cardiovascular structure target position, said expandable member remodels and further abates said perivalvular leak.

4. The sealing apparatus of claim 3, wherein said mammalian tissue source comprises a tissue source selected from the group consisting of the small intestine submucosa, urinary bladder submucosa, stomach submucosa and mesothelial tissue.

5. The sealing apparatus of claim 3, wherein said expandable member comprises a flexible, porous structure.

6. The sealing apparatus of claim 3, wherein said ECM material comprises an exogenously added supplemental biologically active agent.

7. The sealing apparatus of claim 6, wherein said biologically active agent comprises a hemostatic agent.

8. The sealing apparatus of claim 7, wherein said hemostatic agent comprises thrombin.

9. The sealing apparatus of claim 7, wherein said hemostatic agent comprises fibrinogen.

10. The sealing apparatus of claim 7, wherein said hemostatic agent is selected from the group comprising fibronectin, plasminogen, aprotinin, α

-2-antiplasmin, α

-2 macroglobulin, α

-1-antitrypsin, epsilon-aminocaproic acid, and tranexamic acid.

11. The sealing apparatus of claim 6, wherein said biologically active agent comprises chitosan.

12. The sealing apparatus of claim 6, wherein said biologically active agent comprises a HMG-CoA reductase inhibitor selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin

13. The sealing apparatus of claim 6, wherein said biologically active agent comprises a growth factor selected from the group consisting of a platelet derived growth factor (PDGF), transforming growth factor-α

(TGF-α

), transforming growth factor beta (TGF-β

), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF) and vascular epithelial growth factor (VEGF).

14. The sealing apparatus of claim 3, wherein said expandable member comprises a microneedle support member comprising a plurality of biodegradable microneedles.

15. The sealing apparatus of claim 14, wherein said biodegradable microneedles comprise drug-eluting members.

16. A perivalvular leak sealing apparatus, comprising:

a biocompatible, expandable member that is configured to engage an interior region of a prosthetic cardiovascular valve, said expandable member comprising a biocompatible polymeric material selected from the group consisting of polyhydroxyalkonates (PHAs), polylactides (PLLA) and polyglycolides (PLGA) and their copolymers, for example poly(ε

-caprolactone-co-glycolide) and polyanhydrides,

said expandable member being capable of transitioning from a pre-deployment configuration, wherein said expandable member is capable of being positioned within said valve at a first interior valve region when said valve is disposed in a cardiovascular structure,

to a post-deployment configuration, wherein, when said expandable member is disposed in said first interior valve region of said valve, a first outer surface region of said valve proximate said first interior valve region is disposed in intimate contact with said host cardiovascular tissue of said cardiovascular structure at a first cardiovascular structure target position, and wherein a perivalvular leak present at said first cardiovascular structure target position is sealed.