Sealant dressing with removable intermediate separating layer
The present invention is directed to medical devices having a first porous substrate layer with at least a surface coating thereon of a first co-reactive component and a second substrate layer with at least a surface coating layer of a second co-reactive component that reacts with the first co-reactive component, and a removable barrier layer positioned between the first substrate layer and second substrate layer and in contact with said first substrate layer and said second substrate layer.
1. A medical device comprising:
a. a first porous substrate layer having at least one major facing surface with at least a surface coating thereon of a first co-reactive component in a dry form;
b. a second substrate layer having at least one major facing surface with at least a surface coating layer of a second co-reactive component in a dry form that reacts with the first co-reactive component; and
c. a removable inert barrier film layer positioned between the first porous substrate layer and second substrate layer and in contact with at least one major facing surface or a surface coating, each, independently of one another, from said first porous substrate layer and said second substrate layer,
wherein said inert barrier film layer is removable from between the first porous substrate layer and the second substrate layer by pulling, and wherein at least one peripheral edge of the barrier layer extends beyond a peripheral edge of at least one of the first porous substrate layer and the second substrate layer.
2. A medical device according to claim 1 wherein the first porous substrate layer is a porous, non-woven mesh constructed from one or more synthetic polymers or copolymer, cellulosic materials, and blends thereof.
3. A medical device according to claim 2 wherein the second substrate layer is a porous, non-woven mesh constructed from one or more synthetic polymers or copolymer, cellulosic materials, and blends thereof.
4. A medical device according to claim 3 wherein at least one major surface of the first porous substrate layer is coated with a nucleophilic group-containing compound as the first co-reactive component.
5. A medical device according to claim 4 wherein the first porous substrate layer and second substrate layer are maintained in common relative positioning with a plurality of connection points or welds.
6. A medical device according to claim 5 , wherein first porous substrate layer and second substrate layer have edge periphery regions and said plurality of connection points or welds are provided on discreet points along at least one edge periphery region on each of the first porous substrate layer and second substrate layer.
7. A medical device according to claim 6 , wherein at least a plurality of connection points or welds are provided through said inert barrier film layer along an axis of the first porous substrate layer and said second substrate layer.
8. A medical device according to claim 5 , wherein the barrier layer has a slit along and through at least a length portion thereof corresponding to the plurality of connection points or welds that permits said inert barrier film layer to be removed from between said first porous substrate layer and second substrate layer by pulling without having to tear the barrier layer.
9. A medical device according to claim 3 , wherein a non-porous film is applied onto a top facing surface of the second substrate layer.
10. A medical device according to claim 3 wherein at least one major surface of the second substrate layer is coated with an electrophilic group-containing compound as the second co-reactive component.
11. A medical device according to claim 3 wherein the first porous substrate layer, the second substrate layer and the barrier layer are assembled in a sandwich configuration in which the layers are stacked.
12. A medical device according to claim 1 further comprising one or more packaging components, wherein the barrier layer is attached to the one or more packaging components and removed as the medical device is separated from the one or more packaging components.
13. A medical device according to claim 12 , wherein at least one of the one or more packaging components is a containment compartment that has two spatially separate sections for the first and second substrate layers.
14. A medical device according to claim 13 , wherein the containment compartment is a single section to retain the first and second substrate layers.
15. A medical device according to claim 1 , wherein at least one major surface of a substrate layer is coated with polyethylene glycol-N-hydroxysuccinimide.
16. A medical device according to claim 15 , wherein the polyethylene glycol-N-hydroxysuccinimide coated substrate is a tissue-facing surface.
17. A medical device according to claim 15 , wherein the substrate layer is coated on both sides and a polyethylene glycol-N-hydroxysuccinimide is coated on only one side of an opposing porous substrate.
18. A medical device according to claim 1 , wherein the second co-reactive component further comprises an activator for the first co-reactive component.
19. A medical device according to claim 18 , wherein the activator is selected from the group consisting of enzyme, buffering agent, carbodiimides, catalysts and combinations thereof.
20. A medical device according to claim 1 , wherein the second substrate layer is a non-porous film.
21. A medical device according to claim 1 , wherein the first porous substrate layer and second substrate layer are formed by folding a common substrate material along a hinge.
22. A method to achieve hemostasis with the medical device of claim 1 on a bleeding site comprising removing said inert barrier film layer from between said first porous substrate layer and second porous substrate layer by pulling and applying the medical device onto a bleeding tissue site.
23. A method according to claim 22 , wherein a polyethylene glycol-N-hydroxysuccinimide coated substrate is applied directly upon the bleeding tissue site.
24. A method for sealing tissue with the medical device of claim 1 comprising removing said inert barrier film layer from between said first porous substrate layer and second substrate layer by pulling and applying the medical device onto an injured tissue site.
25. A method according to claim 24 , wherein a polyethylene glycol-N-hydroxysuccinimide substrate is applied directly upon the injured tissue site.