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 and the layer including a porous knit mesh formed of a monofilament yarn;
a plurality of naps distributed across at least the first face and projecting therefrom for adhering to tissue; and
a dissolvable matrix layer covering at least a portion of at least the second face of the reinforcing layer opposite the naps.
2. The device of claim 1 , wherein the knit mesh has a thickness from about 1.5 millimeters to about 2.2 millimeters.
3. The device of claim 1 , wherein the length of a nap from its base to summit of its spike is from about 1 millimeter to about 2 millimeters.
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 5 , wherein the knit mesh has a thickness from about 1.5 millimeters to about 2.2 millimeters.
7. The device of claim 5 , wherein the length of a nap from its base to summit of its spike is from about 1 millimeter to about 2 millimeters.
8. The device of claim 1 , wherein the dissolvable layer comprises one or more of a biodegradable component, an antibacterial component, an excipient, therapeutic drug, a plasticizer, and a binder component.
9. The device of claim 8 , 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.
10. The device of claim 9 , wherein the amount of the polymer is about 45 percent w/w of the total weight of the dissolvable layer.
11. The device of claim 8 , wherein the antibacterial component comprises a non-toxic antibacterial agent.
12. The device of claim 11 , wherein the amount of the antibacterial component is from about 0 to about 5% w/w of the dissolvable layer.
13. The device of claim 8 , wherein the therapeutic drug component is uniformly distributed in the dissolvable layer.
14. The device of claim 8 , 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.
15. The device of claim 1 , further comprising a bioadhesive layer.
16. The device of claim 15 , wherein the bioadhesive layer comprises one or more of gelatin, starch, modified starch, proteins, carbohydrates, glycoproteins, mucopolysaccharides, and hydrogels.
17. The device of claim 1 , wherein the monofilament yarn is formed of a polyester.
18. The device of claim 17 , wherein the monofilament yarn is formed of a polyethylene terephthalate.
19. The device of claim 1 , wherein the reinforcement device is formed of a material selected from the group consisting 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, and combinations thereof.