Method of using amnion allograft in heart valve replacement surgery

Abstract

Improved methods for heart valve replacement surgery are described. The methods utilize an allograft comprising a layer of amnion to improve the performance and reduce complications of heart valve replacement surgery and the allograft has a pre-made size and shape suitable for the application.

I/we claim: 
     
         1 . A method of improving a heart valve replacement surgery, comprising applying at least one of an amniotic fluid and an allograft comprising a layer of amnion over a suture line or incision, or an otherwise damaged tissue site resulting from the heart valve replacement surgery, or over or under the pericardium membrane of the subject, wherein the allograft has a pre-made size and shape suitable for the application. 
     
     
         2 . The method of  claim 1 , wherein the heart valve replacement surgery comprises at least one of mitral valve replacement surgery, aortic valve replacement surgery, tricuspid valve replacement surgery, and pulmonary valve replacement surgery. 
     
     
         3 . The method of  claim 1 , wherein the heart valve replacement surgery comprises aortic valve replacement surgery. 
     
     
         4 . The method of  claim 1 , wherein the heart valve replacement surgery comprises Ross Procedure. 
     
     
         5 . The method of  claim 1 , wherein a mechanical valve or a bioprosthetic valve is used in the heart valve replacement surgery. 
     
     
         6 . The method of  claim 1 , wherein the allograft is attached to a tissue of the subject with a 4.0 suture. 
     
     
         7 . The method of  claim 1 , wherein the allograft has a thickness of about 0.02 mm to 0.10 mm. 
     
     
         8 . The method of  claim 1 , wherein the allograft applied over or under the pericardium membrane has an oval shape, about 3 cm to 9 cm in length and about 2 cm to 6 cm in width. 
     
     
         9 . The method of  claim 1 , wherein the allograft consists of a single layer of amnion, two layers of amnion, or a layer of amnion and a layer of chorion. 
     
     
         10 . The method of  claim 1 , wherein the allograft is applied after the completion of the valve replacement and the pericardial cavity is washed with a saline solution comprising one or more anti-microbial agents. 
     
     
         11 . The method of  claim 1 , wherein the allograft further comprises one or more therapeutically active agents selected from the group consisting of anti-microbial agents, growth enhancing agents, anti-inflammatory agents, and other agents that prevent scarring, adhesions and tethering of internal organs and the heart. 
     
     
         12 . The method of  claim 1 , wherein the heart valve replacement surgery is a traditional heart valve replacement surgery or a minimally invasive heart valve replacement surgery. 
     
     
         13 . The method of  claim 1 , further comprising applying a second allograft comprising a layer of amnion over a skin incision at sternum resulting from the heart valve replacement surgery. 
     
     
         14 . The method of  claim 1 , wherein the amnion is obtained using a process comprising:
 a. obtaining informed consent from pregnant females;   b. conducting risk assessment on the consented pregnant females to select an amnion donor;   c. procuring after birth placenta from the amnion donor; and   d. obtaining the amnion from the placenta.   
     
     
         15 . A method of improving a heart valve replacement surgery, comprising applying an allograft comprising a layer of amnion over a skin incision at sternum resulting from the heart valve replacement surgery, wherein the allograft has a pre-made size and shape suitable for the application. 
     
     
         16 . The method of  claim 15 , wherein the allograft has a thickness of about 2 mm to 4 mm. 
     
     
         17 . The method of  claim 15 , wherein the allograft comprises multiple layers of amnion and optionally multiple layers of chorion. 
     
     
         18 . A kit comprising a plurality of allografts and instructions on how to use the allografts to improve a heart valve replacement surgery, wherein each of the plurality of allografts comprises a layer of amnion of a pre-made size and shape suitable for covering a suture line, an incision, or an otherwise damaged tissue site resulting from the heart valve replacement surgery, or for covering over or under the pericardium membrane of the subject. 
     
     
         19 . The kit of  claim 18 , wherein the amnion is obtained using a process comprising:
 a. obtaining informed consent from pregnant females;   b. conducting risk assessment on the consented pregnant females to select an amnion donor;   c. procuring after birth placenta from the amnion donor; and   d. obtaining the amnion from the placenta.   
     
     
         20 . The kit of  claim 18 , comprising an allograft having a thickness of about 0.02 mm to 0.10 mm, and an oval shape of about 3 cm to 9 cm in length and about 2 cm to 6 cm in width, and a second allograft comprising a plurality layers of amnion, and optionally one or more layers of chorion, wherein the second allograft has a thickness of about 2 mm to 4 mm, and a rectangular shape of about 10 cm by 5 cm.