Reinforcement device with dissolvable layer and its use
A reinforcement device for reinforcing tissues having one or more structural deficiencies includes a longitudinally-extending reinforcing layer for treating the structural deficiency, a plurality of spiked naps distributed across the reinforcing layer and projecting therefrom for adhering to the tissue, and a dissolvable matrix layer covering at least a portion of the reinforcing layer and a portion of the plurality of spiked naps. The matrix layer increases the time before the spiked naps substantially adhere to the tissue, thereby allowing the practitioner additional time to position the reinforcement device.
1. A reinforcement device for reinforcing tissues having one or more structural deficiencies, comprising:
a longitudinally extending reinforcing layer for treating the structural deficiency, the layer having a first face and a second face;
a plurality of naps distributed across at least the first face and projecting therefrom for adhering to tissue; and
a dissolvable layer covering the plurality of naps, the layer adapted to increase the time before the naps substantially adhere to the tissue.
2. The device of claim 1 , wherein the reinforcing layer comprises a three-dimensional and open-worked, porous knit.
3. The device of claim 2 , wherein the knit comprises a monofilament polyester yarn.
4. The device of claim 1 , wherein the naps comprise a biocompatible polymer.
5. The device of claim 4 , wherein the biocompatible polymer is selected from one or more of polypropylene, polymers of p-dioxanone, polyglycolides, polyorthoesters, polymers of trimethylene carbonate, stereocopolymers of L-lactic acid and D-lactic acid, homopolymers of L-lactic acid, copolymers of lactic acid and a compatible comonomer.
6. The device of claim 1 , wherein the dissolvable layer comprises one or more of a biodegradable component, an antibacterial component, an excipient, a therapeutic drug, a plasticizer, and a binder component.
7. The device of claim 6 , wherein the biodegradable component is a polymer selected from hydroxy propyl methyl cellulose, hydroxyl propyl cellulose, starch and modified starch, pullulan, pectin, gelatin, and carboxy methyl cellulose.
8. The device of claim 7 , wherein the amount of the polymer is about 45 percent w/w of the total weight of the dissolvable layer.
9. The device of claim 6 , wherein the antibacterial component comprises a non-toxic antibacterial agent.
10. The device of claim 9 , wherein the amount of the antibacterial component is from about 0 to about 5% w/w of the dissolvable layer.
11. The device of claim 6 , wherein the therapeutic drug component is uniformly distributed in the dissolvable layer.
12. The device of claim 6 , wherein the plasticizer is selected from one or more of glycerol, propylene glycol, low molecular weight polyethylene glycols, phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, and citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin and castor oil.
13. The device of claim 1 , further comprising a bioadhesive layer.
14. The device of claim 13 , wherein the bioadhesive layer comprises one or more of gelatin, starch, modified starch, proteins, carbohydrates, glycoproteins, mucopolysaccharides, and hydrogels.
15. The device of claim 1 , wherein an individual nap has a coating of the dissolvable layer of a defined thickness, the thickness of the coating changing over time at a rate greater than the dissolvable layer.