EP-3399946-B1 - BIOROSTHETIC TISSUE REPAIR AND REINFORCEMENT

Inventors

• TIEN, TRACEY
• EBERHARDT, Carol
• GARDE, KSHITIJA
• WONG, BENJAMIN
• WANG, WEI
• HOWARD, Elliot
• MCLINLEY, Laura
• OLNEY, KARL
• WINTERS, Taylor

Dates

Publication Date

20260506

Application Date

20170105

Claims (15)

1. A method (100) of reinforcing a bioprosthetic tissue for use as a prosthetic valve leaflet, comprising: evaluating (108) a bioprosthetic tissue; identifying a naturally occurring defect in the bioprosthetic tissue; and characterized by selectively applying (110) an adhesive to a surface of the bioprosthetic tissue at the defect prior to implantation in a patient.
2. The method (100) of claim 1, wherein the step (110) of selectively applying includes preparing the adhesive by mixing a protein and glutaraldehyde as the adhesive is selectively applied.
3. The method (100) of claim 2, wherein the protein and the glutaraldehyde are separately contained until the adhesive is selectively applied.
4. The method (100) of claim 2, wherein the glutaraldehyde and the protein are mixed in a predetermined ratio.
5. The method (100) of claim 2, wherein the protein is albumin.
6. The method (100) of claim 1, wherein the adhesive is cyanoacrylate.
7. The method (100) of claim 1, wherein the step (110) of selectively applying the adhesive includes filling a fenestration with the adhesive such that the adhesive extends across the fenestration to contact tissue at a perimeter of the fenestration.
8. The method (100) of claim 1, wherein the defect is a separation of tissue layers and the step of selectively applying seals the layers together.
9. The method (100) of claim 1, further comprising after the step (110) of selectively applying the adhesive: assembling the tissue into a prosthetic valve (500), including suturing the bioprosthetic valve leaflets to a valve frame (506); and selectively applying an additive compound to the leaflets at suturing sites.
10. A valve assembly (500), comprising: a valve frame (506); and prosthetic valve leaflets (508) formed of bioprosthetic tissue assembled to the valve frame with mounting members (510), characterized in that at least one of the prosthetic valve leaflets including an adhesive applied at a select area (502, 504) including a naturally occurring defect on a surface of the leaflet.
11. The valve assembly (500) of claim 10, further comprising the adhesive applied to the prosthetic valve leaflet (508) at the select area of penetration openings formed by the mounting members (510).
12. The valve assembly (500) of claim 11, wherein the adhesive is less than 100 µm thick at the penetration openings.
13. The valve assembly (500) of any of claims 10 to 12, wherein the select area (502, 504) has a greater tensile strength than an untreated area of the leaflet.
14. The valve assembly (500) of any of claims 10 to 13, wherein the adhesive is comprised of protein and glutaraldehyde, wherein typically the protein is albumin.
15. The valve assembly (500) of any of claims 10 to 13, wherein the adhesive is cyanoacrylate.

Description

Background Various types and configurations of prosthetic heart valves are used to replace diseased natural human heart valves. The actual shape and configuration of any particularly prosthetic heart valve is dependent to some extent upon the valve being replaced (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). In general, the prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures used with either bioprosthesis or mechanical heart valves prosthesis. The bioprostheses or "tissue valves" are generally made of a suitable animal tissue or materials (e.g., harvested porcine valve leaflets, bovine or equine pericardial leaflets, synthetic material leaflets, etc.) that may be mounted onto a stationary metal or plastic frame, referred to as a "stent". Regardless of whether a stent is provided, bioprosthetic/synthetic heart valves are generally tubular (i.e., when the leaflets are "open", an internal passage is defined through which fluid (e.g., blood) can flow), and include a sewing or suture ring. Leaflets made of biological material can have naturally occurring defects including fenestrations or split on the cut edge of the leaflets. A leaflet including the defect will typically be discarded during production of the valve or the prosthetic heart valve including the defect will be discarded at some other time prior to use in a patient. Additionally, the biological material of the leaflets is penetrated with sutures to assemble the leaflets into the prosthetic heart valve. This can cause weakened points in the biological material. WO 2011/109450 A2 relates to a percutaneously deliverable heart valve and methods associated therewith. US 4 818 291 A relates to a silk-fibroin and human-fibrinogen adhesive composition. US 2002/173770 A1 relates to an adhesive delivery system. US 2007/027528 A1 relates to an elliptical implantable device. WO 92/12690 A1 relates to a heart valve with tissue alignment and clamping. WO 96/03159 A1 relates to an adhesive sealant composition. WO 2014/145811 A1 relates to valved aortic conduits. WO 2010/049160 A1 relates to methods and systems for stent-valve manufacture and assembly. In order to increase the amount of useable leaflets for prosthetic heart valves, repair of fenestrations, splits, and other defects in the leaflets is desired. Additionally, reinforcement of select areas of the valve, including along suture lines, is desirable. <Insert new page 1a> Summary The invention relates to a method of reinforcing a bioprosthetic tissue for use as a prosthetic valve leaflet and a valve assembly and is defined by the appended claims. One aspect provides a method of reinforcing or repairing a bioprosthetic tissue for use as a prosthetic valve leaflet. The method includes evaluating a bioprosthetic tissue, identifying a defect in the bioprosthetic tissue, and selectively applying an adhesive to a surface of the bioprosthetic tissue at the defect prior to implantation in a patient. Another aspect provides a method of constructing a prosthetic heart valve. The method includes fixating a bioprosthetic tissue, cutting the bioprosthetic tissue to form valve leaflets, assembling a prosthetic heart valve including suturing the valve leaflets to a valve frame, and selectively applying an additive compound to the valve leaflets at suturing holes. Another aspect provides a valve assembly including a valve frame, and prosthetic valve leaflets formed of bioprosthetic tissue assembled to the valve frame with mounting members, at least one of the prosthetic valve leaflets including an adhesive applied at a select area including a defect on a surface of the leaflet. Brief Description of the Drawings FIG. 1 is a flow diagram of an exemplary method of tissue reinforcement in accordance with aspects of the present disclosure;FIG. 2 is a flow diagram of an exemplary method of tissue reinforcement in accordance with aspects of the present disclosure;FIG. 3 is a flow diagram of an exemplary method of tissue reinforcement in accordance with aspects of the present disclosure;FIG. 4A is an illustration of a suture site of a tissue;FIG. 4B is an illustration of a suture site of a tissue with a localized reinforced area in accordance with aspects of the present disclosure; andFIG. 5 is an end view of an exemplary prosthetic heart valve including localized treatment areas in accordance with aspects of the present disclosure. Detailed Description Biologic tissue used in bioprosthetic valves can have select areas that are desirable to strengthen without changing the properties, such as flexibility, of the overall tissue. For example, tissue can include naturally occurring defects such as openings or fenestrations which do not affect the performance or function of the valve. The fenestration is a cosmetic defect and native porcine aortic root tissue is often discarded due to these naturally occurring fenestra