AMNION AND CHORION CONSTRUCTS AND USES THEREOF IN MINIMALLY INVASIVE SURGERIES
A construct for use in a minimally invasive surgery is described. The construct contains an allograft having at least one layer of human amnion and chorion tissues, and is adapted for insertion into a small incision or a cannula employed in the minimally invasive surgery for access to the surgical site. The allograft has a shape appropriate for covering the surgical site. Methods of preparing the construct and using it in a minimally invasive surgery are also described. The products and methods improve the performance of the minimally invasive surgery, e.g., by reducing adhesions, scar formation while also reducing inflammation and risk of post-operative infection.
1 . A construct for use in a minimally invasive surgery, the construct comprising an allograft comprising at least one layer of human amnion and chorion tissues, wherein the construct is adapted for insertion into a small incision or a cannula employed in the minimally invasive surgery for access to the surgical site, and the allograft has a shape appropriate for covering the surgical site.
2 . The construct of claim 1 , further comprising a rigid or semi rigid frame of a shape appropriate for insertion through the small incision or the cannula, the frame being disposable or implantable and resorbable.
3 . The construct of claim 2 , wherein the frame comprises a plurality of spokes emanating from the center of the allograft and secured to the patch along the lengths of the spokes, the spokes being movable between a collapsed position proximate each other and an expanded position extending radially from the center of the patch, and the spokes being biased to the expanded position.
4 . The construct of claim 2 , wherein the frame is collapsible.
5 . The construct of claim 2 , wherein the frame is semi-spherical, cylindrical, or generally cylindrical with a C-shaped cross-section.
6 . The construct of claim 1 , further comprising a central shaft, the allograft being movable between a collapsed position enwrapping the central shaft along its longitudinal axis and an expanded position contacting only one end of the central shaft at the center of the patch, wherein the central shaft is disposable or implantable and resorbable.
7 . The construct of claim 1 , having one or more rounded or flattened corners.
8 . The construct of claim 1 , further comprising one or more therapeutic agents to further improve the performance and reduce the complications of the minimally invasive surgery.
9 . A method of preparing a construct for use in a minimally invasive surgery, the method comprising drying an allograft comprising at least one layer of human amnion and chorion tissues over a frame of a shape appropriate for insertion into a small incision or a cannula employed in the minimally invasive surgery for access to the surgical site.
10 . The method of claim 9 , wherein the frame comprises a plurality of spokes, upon drying, the spokes emanating from the center of the allograft and secured to the patch along the lengths of the spokes, the spokes being movable between a collapsed position proximate each other and an expanded position extending radially from the center of the patch, and the spokes being biased to the expanded position.
11 . The method of claim 9 , wherein the frame is collapsible.
12 . The method of claim 9 , wherein the frame is semi-spherical, cylindrical, or generally cylindrical with a C-shaped cross-section.
13 . The method of claim 9 , further comprising placing a central shaft at the center of the patch, upon drying, the allograft being movable between a collapsed position enwrapping the central shaft along its longitudinal axis and an expanded position contacting only one end of the central shaft at the center of the patch, and the central shaft being disposable or implantable and resorbable.
14 . The method of claim 9 , wherein the human amnion and chorion tissues are obtained by 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 amnion and chorion tissues from the placenta.
15 . In a method of performing a minimally invasive surgery, the improvement comprising inserting a construct of claim 1 into the small incision or the cannula employed in the minimally invasive surgery to thereby cover the surgical site with the allograft.
16 . In the method of claim 15 , the improvement further comprising applying one or more allografts comprising at least one layer of human amnion and chorion tissues over one or more suture lines and incisions resulting from the minimally invasive surgery to form a cover and barrier over the suture lines and the incisions.
17 . In the method of claim 15 , wherein the construct further comprises a rigid or semi rigid frame of a shape appropriate for insertion through the small incision or the cannula, the frame being disposable or implantable and resorbable.
18 . In the method of claim 15 , the improvement further comprising applying an amniotic fluid to the surgical site to thereby cover the surgical site with the amniotic fluid.
19 . A kit comprising
(a) a construct for use in a minimally invasive surgery; and
(b) instructions on how to use the construct in the minimally invasive surgery,
wherein the construct comprises an allograft comprising at least one layer of human amnion and chorion tissues, the construct is adapted for insertion into a small incision or a cannula employed in the minimally invasive surgery for access to the surgical site, and the allograft has a shape appropriate for covering the surgical site.
20 . The kit of claim 19 , wherein the frame comprises a plurality of spokes emanating from the center of the allograft and secured to the patch along the lengths of the spokes, the spokes being movable between a collapsed position proximate each other and an expanded position extending radially from the center of the patch, and the spokes being biased to the expanded position.